Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lone Star Circle of Care | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.
In this study, we will assess the effectiveness of a 6-month program delivered by phone by lightly-trained lay people to individuals with diabetes, with the goal of empathetic relationship building and engagement to support day-to-day challenges of managing diabetes and working towards self-management goals. We will recruit from a collaborating Federally Qualified Health Center (FQHC) and use a randomized controlled trial, comparing program to usual care. Telephone callers will be lay people (no formal health training) who will be recruited for authentic interest and empathetic skills and lightly trained on conversational skills, cultural nuances, and how best to support people's individual lifestyle goals on nutrition, exercise, sleep and medication adherence. Callers will encourage participants to seek additional help from their clinic or specific social services as needs arise that benefit from early escalation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program arm | Experimental | Usual Care+ Phase 1 (6 months, months 1-6), Program. Includes empathetic communications (phone & letter), health-promoting incentives, educational materials. Phase 2 (6 months, months 7-12) No Program. During this follow-up period they will receive monthly SMS texts with customized messages encouraging health promoting behaviors. |
|
| Control arm | Other | Usual Care+ Phase 1 (6 months, months 1-6), No Program. Phase 2 (6 months, months 7-12) Material components of program including health-promoting incentives and educational materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empathy in Action for life with diabetes. | Behavioral | In Phase 1 (Months 1-6) participants receive ("Program"):
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C (HbA1c) | Finger stick point-of-care portable device | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9) | Self-administered. Based on the nine DSM-V criteria listed under criterion A for Major Depressive Disorder. Responders are asked to rate the frequency of depression symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (Nearly every day). Items are summed to provide a total score (0-27). The total score serves as a marker of severity and distress (5-9 minimal depressive symptoms; 10-14 minor depression or dysthymia; 15-27 major depressive symptoms). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maninder Kahlon, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lone Star Circle of Care at Ben White Health Clinic | Austin | Texas | 78704 | United States | ||
| Lone Star Circle of Care at El Buen Samaritano |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39656459 | Derived | Kahlon MK, Aksan NS, Aubrey R, Clark N, Cowley-Morillo M, DuBois C, Garcia C, Guerra J, Pereira D, Sither M, Tomlinson S, Valenzuela S, Valdez MR. Glycemic Control With Layperson-Delivered Telephone Calls vs Usual Care for Patients With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448809. doi: 10.1001/jamanetworkopen.2024.48809. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Jan 6, 2023 |
Not provided
Randomized controlled trial, stratified by PHQ-9 baseline scores (cut-off ≥5), on a 1:1 ratio
Not provided
Not provided
Research staff responsible for biomedical data collection at the sites are blinded to the status of the participant as part of control or intervention group. Self-reported outcomes are reported by participants on a tablet.
|
| Control Phase 2 Materials Only | Behavioral |
|
|
| 6 months |
| Diastolic and systolic blood pressure (mmHg) | Direct measurement with automatic blood pressure cuff | 6 months |
| Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7) | Self-administered. Based on some of the DSM-V criteria for General Anxiety Disorder to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed to provide a total score (0-21) to inform severity (1-4 minimal symptoms; 5-9 mild symptoms; 10-14 moderate symptoms; 15-21 severe symptoms). | 6 months |
| General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12) | Self-administered. Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health. | 6 months |
| Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5) | Self-administered. It asks respondents to rate the frequency with which the five different medication-taking behaviors occur. Each items is scored on a five-point scale (5 = never, 4 = rarely, 3 = sometimes, 2 = often, 1 = very often), with higher scores indicating higher reported adherence. | 6 months |
| Perceived Diabetes Self-Management Scale (PDSMS) | Self-administered. The responses for the 8 items PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. | 6 months |
| Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item | Self-Administered. Respondents are asked to score their level of confidence (scale from 1, not at all confident, to 10, totally confident) at the present time in doing tasks related to diabetes management (e.g., diet behavior, physical activity, measuring blood glycemia and others). Higher scores indicate higher self-efficacy. | 6 months |
| Loneliness measured by scores on the 3-item UCLA Loneliness Scale | Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness. | 6 months |
| Diabetes distress measured by the 2-item Diabetes Distress Screening Scale | The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. Higher scores suggest higher diabetes distress. | 6 months |
| Austin |
| Texas |
| 78745 |
| United States |
| Lone Star Circle of Care at Collinfield | Austin | Texas | 78758 | United States |
| Lone Star Circle of Care at Northwest Austin | Austin | Texas | 78759 | United States |
| Lone Star Circle of Care at Bastrop | Bastrop | Texas | 78602 | United States |
| Lone Star Circle of Care at Cedar Park | Cedar Park | Texas | 78613 | United States |
| Lone Star Circle of Care at Lake Aire Medical Center | Georgetown | Texas | 78628 | United States |
| Lone Star Circle of Care at Pflugerville | Pflugerville | Texas | 78660 | United States |
| Lone Star Circle of Care at Texas A&M Health Science Center | Round Rock | Texas | 78665 | United States |
| Apr 27, 2023 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2023 | Apr 27, 2023 | ICF_003.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D000092862 | Psychological Well-Being |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided