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Patients with diabetes are often challenged by the routine of managing their diabetes, and may experience both stress and medical problems. Diabetes-related medical problems and stress often happen together and affect peoples' ability to live a full, happy and healthy life. Because of this, programs that help with medical problems and stress by teaching ways to better manage diabetes and stress may improve the lives of those with diabetes.
Many excellent programs are available in the VA and in the community that help persons with diabetes better manage their medical problems and stress, but often times Veterans have trouble finding these programs.
The purpose of the study is to see if a telephone-based coaching program improves the physical and emotional health of Veterans with diabetes more than use of a directory of community and VA resources and no coaching. The Veterans who receive the directory of community and VA resources will be given this at the beginning of the study and will access resources as they see fit. Those in the coaching program will be coached by a Veteran with knowledge of diabetes, mental health and community resources who will help them connect to care in the VA and/or community depending on their preference. Examples of resources available in the VA and community include mental health care and programs to help with diet, exercise and learning about how to better manage diabetes.
Veterans who are interested in participating and pass screening will be enrolled in the study for about 6 months. Each enrolled Veteran will have a 50% chance of being enrolled in the coaching group and a 50% chance of being enrolled in the directory group (like the flip of a coin). Both groups will be asked to complete several questionnaires about their health and well-being by telephone. This will occur at the beginning of the study and three and six months later. The questionnaires will take about an hour to complete each time.
Diabetes-related distress, the negative emotional impact of living with diabetes (DM), is a powerful predictor of psychosocial functioning, treatment adherence, and glycemic control. Practice guidelines and consensus statements call for innovative approaches to address DM-related distress. Despite availability of self-management and psychosocial interventions to reduce DM related distress, these interventions are underutilized due to constraints in time, finances, motivation, and resource-awareness. Interventions that leverage traditional medical care and community-based health promotion programs (e.g., DM self-management education (DSME) programs) may enhance the ability of Veterans with DM to engage with a broad and accessible range of resources. Ensuring that Veterans with DM receive adequate self-care support requires interventions that (1) attend to both medical care and diabetes-related distress and (2) improve Veterans' access and engagement with DSME and traditional medical/mental care. Integrating VA and community health services and DSME resources is innovative and affords great opportunities to enhance Veteran outcomes and build VA community partnerships. Engagement of Veterans and community organizations in developing and delivering care responds to the 2016 HSR&D high-priority domain of Health Care Systems Change and aligns with the 2017 VA Under Secretary's priorities of Greater Choice (offering community and VA resources), Efficiency (community and VA coordination), and Timeliness (telephone delivery).
This community-VA partnership and three-month Veteran peer coaching intervention (iNSPiRED) aims to enhance psychological well-being and diabetes self-management behavior in Veterans with DM by facilitating access to and use of healthcare and health promotion resources. The intervention focuses on reducing cognitive and practical barriers to use of services by engaging Veteran peers as coaches and navigators, and by encouraging engagement in health promotion and healthcare services in the VA and the greater community. A secondary goal, integral to the main goal, is to strengthen and integrate VHA partnerships with community-based organizations and Veteran Support Organizations (VSO's).
This is a single-blind, parallel group randomized trial of a 3-month peer navigation intervention for Veterans with DM and elevated levels of DM-related distress. The investigators will recruit Veterans with DM-related distress through existing help-seeking channels within and outside of the VA in partnership with community agencies, VSO's, and the Houston VAMC. Eligible Veterans will be assigned at random to the iNSPiRED intervention (peer navigation and coaching) versus usual care (written resource materials and encouragement to continue follow-up with healthcare providers). Consistent with the focus on the overall emotional impact of DM, the PRIMARY OUTCOME is DM-related distress (DM Distress Scale). In previous studies the DDS has shown strong relationships with psychological symptoms, self-management behaviors, and objective measures of glycemic control. SECONDARY OUTCOMES include anxiety symptoms (Generalized Anxiety Disorder Scale), depression symptoms (Patient Health Questionnaire-8), DM self-management behaviors (DM Self-Management Scale), and self-reported use and new use of VA or community resources. In addition to participant-level outcomes, the investigators will also assess STAKEHOLDER OUTCOMES through a mixed methods process evaluation. The objective will be to measure the impact of stakeholder engagement activities on development and sustainability of VA-community partnerships, trust and communication, and capacity building. Assessment of primary and secondary endpoints will occur at baseline, post-intervention, and at 6 months.
If this project meets intended goals, the investigators will partner with VHA Office of Community Engagement and VHA Specialty Care to implement the intervention for DM and other chronic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNSPiRED | Experimental | Peer coaching intervention |
|
| Usual Care | Active Comparator | Directory of resources and encouragement to follow-up with Primary Care Physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNSPiRED | Behavioral | The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Distress Screening Scale (DDS17) | The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden ("Feeling angry, scared and/or depressed when I think about living with diabetes"), Physician-related Distress ("Feeling that my doctor doesn't take my concerns seriously enough"), Regimen-related Distress ("Not feeling confident in my day-to-day ability to manage diabetes"), and Interpersonal Distress ("Feeling that friends or family don't give me the emotional support that I would like"). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress. | Baseline, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, fruits and vegetable intake, fat intake, physical activity, blood-glucose testing, and foot care. and smoking. Minimum score 0. Maximum score 7 (for each area). Higher scores indicate better self care. Smoking in the last week is also assessed as a binary variable (see separate entry). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Use of VHA Resources (no to Yes) | The investigators will record the Veteran's self-report of use of VHA resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous Yes = care in VHA. No= no care in VHA. | Baseline, Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark E. Kunik, MD MPH | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37674395 | Background | Cully JA, Hundt NE, Fletcher T, Sansgiry S, Zeno D, Kauth MR, Kunik ME, Sorocco K. Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial. Psychiatr Serv. 2024 Mar 1;75(3):237-245. doi: 10.1176/appi.ps.20220582. Epub 2023 Sep 7. | |
| 36828990 | Background |
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Final data sets underlying publications from this research will be made available to the public in electronic form. The investigators will provide a de-identified, quantitative dataset compliant with VA data security policy to the public upon request to the principal investigator. Qualitative data cannot be shared because it has identifiable, sensitive information that cannot be practicably de-identified. Notices advising the public of the availability of the dataset will appear in all publications authored by our research team.
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After the data is analyzed and published
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One participant who provided informed consent withdrew prior to completing baseline/randomization.
Of the 1,614 Veterans considered for study entry (1,499 referred from VA sources, 110 referred from community sources, 5 referred from both VA and community sources), 1,109 were contacted, 503 were screened, and 219 were eligible/provided informed consent for study participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | iNSPiRED | Peer coaching intervention iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided. |
| FG001 | Usual Care | Directory of resources and encouragement to follow-up with Primary Care Physician Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Phase |
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| Follow-up Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | iNSPiRED | Peer coaching intervention iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Diabetes Distress Screening Scale (DDS17) | The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden ("Feeling angry, scared and/or depressed when I think about living with diabetes"), Physician-related Distress ("Feeling that my doctor doesn't take my concerns seriously enough"), Regimen-related Distress ("Not feeling confident in my day-to-day ability to manage diabetes"), and Interpersonal Distress ("Feeling that friends or family don't give me the emotional support that I would like"). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress. | Full sample | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, Month 6 |
|
Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iNSPiRED | Peer coaching intervention iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Homicidal ideation | Social circumstances | Non-systematic Assessment |
Connecting participants to medical care and resources for diabetes and mental health self-management was a primary component of the peer coaching intervention. The COVID-19 pandemic reduced the availability of these resources. The impact of reduced availability of resources on the study results is unknown.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalie E. Hundt | Michael E. DeBakey VAMC | 713-791-1414 | 10315 | natalie.hundt@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2022 | Jun 8, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2018 | Mar 29, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| D006295 | Health Resources |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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This is a single-blind, parallel group, randomized trial of a 3-month peer-navigation intervention for Veterans with DM and elevated levels of diabetes-related distress. Participants will be assigned at random (see below) to the intervention (peer navigation with follow-up) or usual care (print materials and encouragement to continue follow-up with health care providers). Assessment of primary, secondary and intermediate end points will occur pre-intervention at baseline and post-intervention at 3 and 6 months.
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| Usual Care | Other | Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations |
|
| Baseline, Month 3, Month 6 |
| Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. Any smoking in the last week is assessed as a binary variable. Minimum score 0 (did not smoke). Maximum score 1 (smoked). See separate entry for SDSCA items that measure the number of days per week an activity is performed. Reported counts reflect number of participants who indicated smoking in the last week. | Baseline, Month 3, Month 6 |
| Change in Patient Health Questionnaire-8 (PHQ-8) | The PHQ-8 is an eight-item questionnaire that assesses the frequency of depression and mood-related symptoms (e.g., "Feeling down, depressed, or hopeless," "Trouble falling or staying asleep, or sleeping too much") over the past 2 weeks. Minimum score 0. Maximum score 24. Higher scores indicate worse depression. | Baseline, Month 3, Month 6 |
| Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | The GAD-7 is a 7-item questionnaire developed as a companion to the PHQ-9 to screen for generalized anxiety disorder and other common anxiety disorders. Items assess the frequency of anxiety symptoms (e.g., "Worrying too much about different things," "Feeling afraid as if something awful might happen") over the past 2 weeks. Minimum score 0. Maximum score 21. Higher scores indicate worse anxiety. | Baseline, Month 3, Month 6 |
| Change in Use of Community Resources (no to Yes) | The investigators will record the Veteran's self-report of any use of community-based resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous. Yes = care in the community. No= no care in the community | Baseline, Month 6 |
| Change in Patient Activation Measure (PAM) |
The Patient Activation Measure (PAM) is designed to measure the extent to which patients endorse subjective ability to self-manage their chronic health conditions. Items assess several aspects of self-management, including knowledge (e.g., "I know what each of my prescribed medications do"), skill (e.g., "I have been able to maintain the lifestyle changes for my health that I have made"), and confidence (e.g., "I am confident I can tell my health care provider concerns I have even when he or she does not ask"). Raw scores: Minimum 13. Maximum 52. Scaled scores ("Activation" scores): Minimum 0.0. Maximum 100.0. Higher scores indicate more patient activation. |
| Baseline, Month 3, Month 6 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a measures self-efficacy related to managing emotions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 24.82 Maximum score 63.45. Higher scores indicate higher self-efficacy. | Baseline, Month 3, Month 6 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a measures self-efficacy related to managing daily activities. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 26.02 Maximum score 59.26. Higher scores indicate higher self-efficacy. | Baseline, Month 3, Month 6 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a measures self-efficacy related to managing social interactions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 23.08 Maximum score 58.19. Higher scores indicate higher self-efficacy. | Baseline, Month 3, Month 6 |
| Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey | The investigators will measure stakeholder engagement from the researcher's perspective using a modified version of the PCORI WE-ENACT Researcher Survey, completed annually. One group of researchers (the primary investigator and three team members) involved in stakeholder engagement completed the survey together at each time point. The Outcome Measure Data Table includes the number of participants who completed the survey (1 group of researchers). | Baseline and every 12 months assessed up to month 48 |
| Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey | The investigators will measure engagement from the community partner perspective using the PCORI WE-ENACT Patient and Stakeholder Survey, completed annually. This measure includes items to describe engagement from the stakeholder's point of view. One or two key representatives from each community partner agency will participate. The Outcome Measure Data Table includes the number of participants who completed the survey. | Baseline and every 12 months assessed up to month 48. |
| Dawson DB, Mohankumar R, Puran D, Nevedal A, Maguen S, Timko C, Kunik ME, Breland JY. Weight Management Treatment Representations: A Novel Use of the Common Sense Model. J Clin Psychol Med Settings. 2023 Dec;30(4):884-892. doi: 10.1007/s10880-023-09946-4. Epub 2023 Feb 24. |
| 36253766 | Background | Chen GJ, Kunik ME, Marti CN, Choi NG. Cost-effectiveness of Tele-delivered behavioral activation by Lay counselors for homebound older adults with depression. BMC Psychiatry. 2022 Oct 17;22(1):648. doi: 10.1186/s12888-022-04272-9. |
| 36096091 | Background | Mishra RK, Park C, Momin AS, Rafaei NE, Kunik M, York MK, Najafi B. Care4AD: A Technology-Driven Platform for Care Coordination and Management: Acceptability Study in Dementia. Gerontology. 2023;69(2):227-238. doi: 10.1159/000526219. Epub 2022 Sep 12. |
| 36003211 | Background | Boykin DM, Wray LO, Funderburk JS, Holliday S, Kunik ME, Kauth MR, Fletcher TL, Mignogna J, Roberson RB 3rd, Cully JA. Leveraging the ExpandNet framework and operational partnerships to scale-up brief Cognitive Behavioral Therapy in VA primary care clinics. J Clin Transl Sci. 2022 Jul 20;6(1):e95. doi: 10.1017/cts.2022.430. eCollection 2022. |
| 35853418 | Background | Choi NG, Choi BY, Marti CN, Kunik ME. Depression/anxiety symptoms and self-reported difficulty managing medication regimen among community-dwelling older adults. Gen Hosp Psychiatry. 2022 Sep-Oct;78:50-57. doi: 10.1016/j.genhosppsych.2022.07.005. Epub 2022 Jul 15. |
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| BG001 | Usual Care | Directory of resources and encouragement to follow-up with Primary Care Physician Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
|
| Annual Income | Count of Participants | Participants |
|
| 17-item Diabetes Distress Scale (DDS17)--Total Score | The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden, Physician-related Distress, Regimen-related Distress, and Interpersonal Distress. Items are rated on a Likert scale indicating the extent to which each factor is distressing. The instrument is scored by computing the average value across items to obtain a total score. Minimum score 1. Maximum score 6. Higher scores indicate worse distress. | Mean | Standard Deviation | units on a scale |
|
| Uses any diabetes medication | Count of Participants | Participants |
|
| Uses insulin | Count of Participants | Participants |
|
| Ever hospitalized for diabetes | Count of Participants | Participants |
|
| iNSPiRED |
Peer coaching intervention iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided. |
| OG001 | Usual Care | Directory of resources and encouragement to follow-up with Primary Care Physician Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations |
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| Secondary | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, fruits and vegetable intake, fat intake, physical activity, blood-glucose testing, and foot care. and smoking. Minimum score 0. Maximum score 7 (for each area). Higher scores indicate better self care. Smoking in the last week is also assessed as a binary variable (see separate entry). | Full sample. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, Month 6 |
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| Secondary | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. Any smoking in the last week is assessed as a binary variable. Minimum score 0 (did not smoke). Maximum score 1 (smoked). See separate entry for SDSCA items that measure the number of days per week an activity is performed. Reported counts reflect number of participants who indicated smoking in the last week. | Variation in cell sizes due to missing data. | Posted | Count of Participants | Participants | Baseline, Month 3, Month 6 |
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| Secondary | Change in Patient Health Questionnaire-8 (PHQ-8) | The PHQ-8 is an eight-item questionnaire that assesses the frequency of depression and mood-related symptoms (e.g., "Feeling down, depressed, or hopeless," "Trouble falling or staying asleep, or sleeping too much") over the past 2 weeks. Minimum score 0. Maximum score 24. Higher scores indicate worse depression. | Full sample | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, Month 6 |
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| Secondary | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | The GAD-7 is a 7-item questionnaire developed as a companion to the PHQ-9 to screen for generalized anxiety disorder and other common anxiety disorders. Items assess the frequency of anxiety symptoms (e.g., "Worrying too much about different things," "Feeling afraid as if something awful might happen") over the past 2 weeks. Minimum score 0. Maximum score 21. Higher scores indicate worse anxiety. | Full sample | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, Month 6 |
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| Secondary | Change in Use of Community Resources (no to Yes) | The investigators will record the Veteran's self-report of any use of community-based resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous. Yes = care in the community. No= no care in the community | Full sample | Posted | Number | participants | Baseline, Month 6 |
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| Other Pre-specified | Change in Use of VHA Resources (no to Yes) | The investigators will record the Veteran's self-report of use of VHA resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous Yes = care in VHA. No= no care in VHA. | Full sample | Posted | Number | participants | Baseline, Month 6 |
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| Other Pre-specified | Change in Patient Activation Measure (PAM) | The Patient Activation Measure (PAM) is designed to measure the extent to which patients endorse subjective ability to self-manage their chronic health conditions. Items assess several aspects of self-management, including knowledge (e.g., "I know what each of my prescribed medications do"), skill (e.g., "I have been able to maintain the lifestyle changes for my health that I have made"), and confidence (e.g., "I am confident I can tell my health care provider concerns I have even when he or she does not ask"). Raw scores: Minimum 13. Maximum 52. Scaled scores ("Activation" scores): Minimum 0.0. Maximum 100.0. Higher scores indicate more patient activation. | Full sample | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, Month 6 |
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| Other Pre-specified | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a measures self-efficacy related to managing emotions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 24.82 Maximum score 63.45. Higher scores indicate higher self-efficacy. | Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data. | Posted | Mean | Standard Deviation | T-score | Baseline, Month 3, Month 6 |
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| Other Pre-specified | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a measures self-efficacy related to managing daily activities. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 26.02 Maximum score 59.26. Higher scores indicate higher self-efficacy. | Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data. | Posted | Mean | Standard Deviation | T-scores | Baseline, Month 3, Month 6 |
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| Other Pre-specified | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a measures self-efficacy related to managing social interactions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 23.08 Maximum score 58.19. Higher scores indicate higher self-efficacy. | Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data. | Posted | Mean | Standard Deviation | T-scores | Baseline, Month 3, Month 6 |
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| Other Pre-specified | Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey | The investigators will measure stakeholder engagement from the researcher's perspective using a modified version of the PCORI WE-ENACT Researcher Survey, completed annually. One group of researchers (the primary investigator and three team members) involved in stakeholder engagement completed the survey together at each time point. The Outcome Measure Data Table includes the number of participants who completed the survey (1 group of researchers). | Posted | Count of Participants | Participants | Baseline and every 12 months assessed up to month 48 |
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| Other Pre-specified | Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey | The investigators will measure engagement from the community partner perspective using the PCORI WE-ENACT Patient and Stakeholder Survey, completed annually. This measure includes items to describe engagement from the stakeholder's point of view. One or two key representatives from each community partner agency will participate. The Outcome Measure Data Table includes the number of participants who completed the survey. | Posted | Count of Participants | Participants | Baseline and every 12 months assessed up to month 48. |
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| 2 |
| 110 |
| 12 |
| 110 |
| 1 |
| 110 |
| EG001 | Usual Care | Directory of resources and encouragement to follow-up with Primary Care Physician Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations | 0 | 108 | 11 | 108 | 0 | 108 |
| Death | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
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| Hospitalization | Cardiac disorders | Non-systematic Assessment |
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| Death | Cardiac disorders | Non-systematic Assessment |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hospitalization | General disorders | Non-systematic Assessment |
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| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Hospitalization | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hospitalization | Nervous system disorders | Non-systematic Assessment |
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| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| Baseline--Specific Diet (Fruits and Vegetables) |
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| Baseline--Specific Diet (Fat) |
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| Baseline--Physical Activity |
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| Baseline--Blood Glucose Testing |
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| Baseline--Foot Care |
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| Month 3--General Diet |
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| Month 3--Specific Diet (Fruits and Vegetables) |
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| Month 3--Specific Diet (Fat) |
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| Month 3--Physical Activity |
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| Month 3--Blood Glucose Testing |
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| Month 3--Foot Care |
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| Month 6--General Diet |
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| Month 6--Specific Diet (Fruits and Vegetables) |
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| Month 6--Specific Diet (Fat) |
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| Month 6--Physical Activity |
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| Month 6--Blood Glucose Testing |
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| Month 6--Foot Care |
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| Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3 | Mixed Models Analysis | 0.83 | Interaction Term | 0.07 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Specific Diet (Fat) - Treatment Effect - Month 3 | Mixed Models Analysis | 0.12 | alpha = 0.05 | Interaction Term | -0.44 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Physical Activity - Treatment Effect - Month 3 | Mixed Models Analysis | 0.17 | alpha = 0.05 | Interaction Term | 0.39 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Blood Glucose Testing - Treatment Effect - Month 3 | Mixed Models Analysis | 0.85 | alpha = 0.05 | Interaction Term | 0.06 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Foot Care - Treatment Effect - Month 3 | Mixed Models Analysis | 0.94 | alpha = 0.05 | Interaction Term | 0.02 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| General Diet - Treatment Effect - Month 6 | Mixed Models Analysis | 0.47 | alpha = 0.05 | Interaction Term | 0.19 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6 | Mixed Models Analysis | 0.82 | alpha = 0.05 | Interaction Term | 0.08 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Specific Diet (Fat) - Treatment Effect - Month 6 | Mixed Models Analysis | 0.66 | alpha = 0.05 | Interaction Term | -0.13 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Physical Activity - Treatment Effect - Month 6 | Mixed Models Analysis | 0.38 | alpha = 0.05 | Interaction Term | 0.25 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Blood Glucose Testing - Treatment Effect - Month 6 | Mixed Models Analysis | 0.68 | alpha = 0.05 | Interaction Term | -0.12 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Foot Care - Treatment Effect - Month 6 | Mixed Models Analysis | 0.40 | alpha = 0.05 | Interaction Term | 0.26 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Yes - Month 3 |
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| Yes - Month 6 |
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| Month 3 |
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| Month 6 |
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| Treatment Effect - Month 6 | Mixed Models Analysis | 0.38 | alpha = 0.05 | Interaction Term | 0.63 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Month 3 |
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| Month 6 |
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| Treatment Effect - Month 6 | Mixed Models Analysis | 0.18 | alpha = 0.05 | Interaction Term | 0.99 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Month 3 |
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| Month 6 |
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| Treatment Effect - Month 6 | Mixed Models Analysis | 0.68 | alpha = 0.05 | Interaction Term | 1.64 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Month 3 |
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| Month 6 |
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| Treatment Effect - Month 6 | Mixed Models Analysis | 0.62 | alpha = 0.05 | Interaction Term | 0.29 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Month 3 |
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| Month 6 |
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| Treatment Effect - Month 6 | Mixed Models Analysis | 0.58 | alpha = 0.05 | Interaction Term | -0.24 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |
| Month 3 |
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| Month 6 |
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| Treatment Effect - Month 6 | Mixed Models Analysis | 0.18 | alpha = 0.05 | Interaction Term | 0.72 | 2-Sided | Superiority | Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori. |