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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK135885-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:
Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.
The Older Adults using Social Support to Improve Self-Care (OASIS) intervention is an asset-based approach, utilizing the unique social structure existing in Kentucky's rural Appalachian communities to address self-care behaviors as they relate to Type 2 Diabetes Mellitus (T2DM) management. The intervention will be composed of two groups: peer coaches who have managed T2DM (HbA1c < 7.5%), and peer participants who have unmanaged T2DM (HbA1c ≥ 7.5%). Peer coaches will undergo training prior to intervention initiation to develop coaching skills. Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. In addition to evaluating the effectiveness of a peer coaching model, the four groups will be evaluated allowing for a more detailed understanding of factors that influence self-care behaviors. Stakeholders will also be engaged at three time points: prior to the intervention, study mid-point, and at study conclusion. At study conclusion, a small cohort of both peer participants and peer coaches will be invited to contribute to stakeholder group interviews. Information exchange with stakeholders will aid in developing a robust understanding of influential factors and how to effectively promulgate the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Participant Group A | Other | Participants will self-select their peer coach and will receive contact once a week. |
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| Peer Participant Group B | Other | Participants will self-selected their peer coach and will receive contact every 2 weeks |
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| Peer Participant Group C | Other | Participants will be matched with a peer coach and will receive contact once a week |
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| Peer Participant Group D | Other | Participants will be matched with a peer coach and will receive contact every 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Coach Training - Weekly | Behavioral | Peer participants will be contacted by peer coaches on a weekly basis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with change in A1c | Obtained using point of care assessment | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Empowerment | "Attitudes Towards Diabetes - DES". 5 point scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", where lower scores indicate greater feelings of empowerment. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Quality of Life Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittany L. Smalls, PhD | Contact | 409-772-1011 | blsmalls@utmb.edu | |
| Kindness C. Akwari, MS | Contact | 502-627-0591 | kcakwari@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brittany L. Smalls, PhD | University of Texas Medial Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barren River Area Development District | Recruiting | Bowling Green | Kentucky | 42101 | United States |
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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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Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. Profile sheets that detail age, region of residence, hobbies etc. of each peer coach will be provided to peer participants who will then rank their top three choices. Matching will be completed by study personnel, and will be based mostly in region of residence.
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| Peer Coach Training - Biweekly | Behavioral | Peer participants will be contacted by peer coaches on a bi-weekly basis |
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"EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL. |
| Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Social Support | "MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Depression Scale | "Geriatric Depression Scale: Short Form" is a binary survey where participants can select "yes" or "no". Each "yes" is a singular point, if a score >5 points it is suggestive about depression and warrant a follow-up comprehensive assessment. A score of greater than or equal to 10 is almost always indicative of depression. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Problem Areas in Diabetes | "Problem Areas In Diabetes (PAID) Scale" a five point scale ranging from 0 "not a problem" to 4 "serious problem", where a higher score indicates more problems in diabetes management. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Diabetes Self-Management | Diabetes Self-Management Questionnaire (DSMQ) is a four point scale ranging from 0 "does not apply to me" to 3 "applies to me very much". Higher scores indicate better diabetes management. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Acts of Daily Living | "Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L) is a binary where "0" is low functioning and "1" is high functioning. Higher scores indicate higher functioning | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Social Network Scale | "Lubbens Social Network Scale - 6 (LSNS-6) is a five point scale ranging from "0" none to "5" nine or more. Higher scores indicate greater amount of social support. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Diabetes Knowledge Questionnaire | "Diabetes Knowledge Questionnaire (DKQ)" is a 24-item survey that has shown sensitivity to a diabetes knowledge intervention; additionally, it targets knowledge deficits which can be related to measurable outcomes, false statements, or common and/or serious misconceptions. Participants can select "yes", "no", or "don't know". | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Problem Solving Skills | "Diabetes Problem-Solving Inventory (DPSI)" includes 9 items that assess how individuals living with diabetes cope with challenges of T2D-related self-care. The inventory measures three components: healthy eating, physical activity, and stress management. Overall problem-solving rating is provided on a 5-point scale from 1 "(very poor strategy)" to 5 "(excellent strategy)". | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Brooks Medication Adherence | "Brooks Medication Adherence Scale" is a 6-item scale and is sensitive to changes in adherence due to intervention. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| Frailty | "Pictorial Fit-Frail Scale" measures frailty phenotype using a validated assessment that characterizes frailty by exhaustion, low physical activity, weakness, and low body mass index. Individuals are characterized as frail if they have affirmative responses to 3 or 4 of the items. By identifying frailty phenotype, individuals at increased risk for adverse health outcomes can be identified, which serves as an indicator for complex patient management. | Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention. |
| UK HealthCare | Recruiting | Hazard | Kentucky | 41701 | United States |
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| D004700 | Endocrine System Diseases |