Clinical trial NCT06336122: OASIS: Peer Support for T2DM in Appalachia (Peer Participant)
Official title: Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Appalachian Region
Peer Influence
Diabetes Mellitus, Type 2
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-03-28
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 55 years
* Resident in Rural Kentucky
* Positive Diagnosis of Type 2 Diabetes Mellitus
* HbA1c greater than or equal to 7.5%
* 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
* No Type 2 Diabetes Mellitus Diagnosis
* HbA1c under 7.5%
* Cognitive Impairment
* Non-english speaking

Primary outcomes:
measure: Number of participants with change in A1c
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
Secondary outcomes:
measure: Diabetes Empowerment
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Quality of Life Index
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Social Support
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Depression Scale
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Problem Areas in Diabetes
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Diabetes Self-Management
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Acts of Daily Living
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
measure: Social Network Scale
timeFrame: Collected at Baseline, 3 month, and 6 month follow up.
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Barren River Area Development District
state: Kentucky
city: Hazard
country: United States
facility: UK HealthCare
state: Kentucky
Study officials:
References: