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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK133553 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Minnesota | OTHER |
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This single-arm trial of the Diabetes Homeless Medication Support intervention for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.
This study has an overall goal to modify and pilot test a previously developed collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). The intervention was developed in English. This study is intended to test the modified intervention for DH who speak Spanish (DH-SH). The study team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH-SH.
This protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the D-Homes treatment manual through test cases (n=12). The study team hypothesizes that the D-Homes manual and study procedures will be feasible and acceptable to DH-SH as measured by self-report and post-treatment interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DH-Spanish Intervention | Experimental | Behavioral treatment by a diabetes wellness coach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Homelessness Medication Support Program in Spanish | Behavioral | There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention | Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction. | at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Control | We will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using blood samples collected via venipuncture. We will compare glycemic control from baseline to 16 weeks. | Baseline and 16 weeks |
| Health-related Quality of Life |
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Inclusion Criteria:
Age 18 yrs or older
Spanish-speaking
Recent homelessness by federal definition (HEARTH ACT)
Self-reported diagnosis of type 2 diabetes, later verified in medical record
Plan to stay in local area or be reachable by phone for the next 16 weeks
Willingness to work on medication adherence and diabetes self-care
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine D Vickery, MD | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24209600 | Background | Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26. | |
| 9523497 | Background | Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. doi: 10.1023/a:1008809610703. |
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Initial phone screener = 23 In person screening = 21 Excluded after in person screening = 9 for reason A1c below 7.5
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| ID | Title | Description |
|---|---|---|
| FG000 | DH-Spanish Intervention | Behavioral treatment by a diabetes wellness coach. Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DH-Spanish Intervention | Behavioral treatment by a diabetes wellness coach. Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed. |
| 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 | Acceptability of Intervention | Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction. | Posted | Mean | Standard Deviation | score on a scale | at 16 weeks |
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Adverse event data was collected for the entire 16 weeks of each participant's involvement in the study.
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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 | DH-Spanish Intervention | Behavioral treatment by a diabetes wellness coach. Diabetes Homelessness Medication Support Program in Spanish: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief diabetes education as needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Diaz Vickery | Hennepin Healthcare Research Institute | 612-873-6852 | katherine.vickery@hcmed.org |
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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 | Aug 21, 2023 | Aug 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2023 | Aug 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This will be an in-person, phone, or video based behavioral intervention. It will involve a diabetes wellness coach assisting participants to use behavioral activation and motivational interviewing to set goals related to diabetes self-care and co-morbidities or social conditions that get in the way of diabetes self-care. There will be encouragement to work on diabetes medication adherence and to address any un/under-treated behavioral health conditions.
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As measured by the 12 Item Short Form Survey (SF-12), a 12-question questionnaire. The SF-12 is analyzed for two summary scores - the physical component score (PCS-12) and the mental component score (MCS-12). The average score of each component is 50 for people in the United States, with a standard deviation of 10 points. Scores above 50 indicate higher than average health-related quality of life while scores below 50 indicate lower than average health-related quality of life. |
| Baseline and 16 weeks |
| Diabetes Medication Adherence | As measured by the Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes. We will compare ARMS-D scores from baseline to 16 weeks. | Baseline and 16 weeks |
| 10267258 | Background | Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Change in Glycemic Control | We will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using blood samples collected via venipuncture. We will compare glycemic control from baseline to 16 weeks. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline and 16 weeks |
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| Secondary | Health-related Quality of Life | As measured by the 12 Item Short Form Survey (SF-12), a 12-question questionnaire. The SF-12 is analyzed for two summary scores - the physical component score (PCS-12) and the mental component score (MCS-12). The average score of each component is 50 for people in the United States, with a standard deviation of 10 points. Scores above 50 indicate higher than average health-related quality of life while scores below 50 indicate lower than average health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 16 weeks |
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| Secondary | Diabetes Medication Adherence | As measured by the Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes. We will compare ARMS-D scores from baseline to 16 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 16 weeks |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
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| 16 weeks - MCS12 |
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