OASIS: Peer Support for T2DM in Appalachia

Study Overview
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Brief Summary
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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: Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management? If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training. Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting. 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.

Detailed Description
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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.

Official Title
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Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Peer Coaching - Peer Participants A
* Behavioral: Peer Coaching - Peer Participants B
* Behavioral: Peer Coaching - Peer Participants C
* Behavioral: Peer Coaching - Peer Participants D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 55 years Resident in Rural Kentucky Positive diagnosis of Type 2 Diabetes Mellitus HbA1c greater than 7.5 for peer participants HbA1c less than 7.5 for peer coaches Passing score on cognitive assessment administered by study personnel English Speaking Exclusion Criteria: Age less than 55 years Not a resident of a Rural Kentucky county Cognitive Impairment Non-English Speaking

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Participants (A)<br>Peer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period. | Behavioral: Peer Coaching - Peer Participants A<br>* Peer participants in group A will self select a peer coach and will be contacted weekly by peer coaches.<br>|
| Experimental: Peer Participants (B)<br>Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted biweekly during intervention period. | Behavioral: Peer Coaching - Peer Participants B<br>* Peer participants in group B will self select a peer coach and will be contacted bi-weekly by peer coaches.<br>|
| Experimental: Peer Participants (C)<br>Peer participants in group C will be matched with a peer coach by study personnel, and will be contacted weekly during intervention period. | Behavioral: Peer Coaching - Peer Participants C<br>* Peer participants in group C will be matched with a peer coach and will be contacted weekly by peer coaches.<br>|
| Experimental: Peer Participant (D)<br>Peer participants in group D will be matched with a peer coach by study personnel, and will be contacted biweekly during intervention period. | Behavioral: Peer Coaching - Peer Participants D<br>* Peer participants in group D will be matched with a peer coach and will be contacted bi-weekly by peer coaches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Change in A1c | Obtained using Point of Care assessment | Collected at Baseline, 3 month, and 6 month follow up. | 

Secondary Outcome Measures

| Outcome Measure | 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, 3 month, and 6 month follow up. | 
| Quality of Life Index | 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, 3 month, and 6 month follow up. | 
| 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, 3 month, and 6 month follow up. | 
| 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, 3 month, and 6 month follow up. | 
| 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, 3 month, and 6 month follow up. | 
| 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, 3 month, and 6 month follow up. | 
| Acts of Daily Living | Lawton-Brody Instrumental Activities of Daily Living Scale (L.A.D.L) is a binary where 0 is low functioning and 1 is high functioning. Higher scores indicate higher functioning. | Collected at Baseline, 3 month, and 6 month follow up. | 
| 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, 3 month, and 6 month follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appalachian Region, Peer Influence, Diabetes Mellitus, Type 2