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Clinical Trials/NCT06336122
NCT06336122
Recruiting
Not Applicable

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

University of Kentucky2 sites in 1 country76 target enrollmentNovember 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
University of Kentucky
Enrollment
76
Locations
2
Primary Endpoint
Number of participants with change in A1c
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
March 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brittany L Smalls

Associate Professor

University of Kentucky

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

Outcomes

Primary Outcomes

Number of participants with change in A1c

Time Frame: Collected at Baseline, 3 month, and 6 month follow up.

Obtained using point of care assessment

Secondary Outcomes

  • Diabetes Empowerment(Collected at Baseline, 3 month, and 6 month follow up.)
  • Quality of Life Index(Collected at Baseline, 3 month, and 6 month follow up.)
  • Depression Scale(Collected at Baseline, 3 month, and 6 month follow up.)
  • Diabetes Self-Management(Collected at Baseline, 3 month, and 6 month follow up.)
  • Social Support(Collected at Baseline, 3 month, and 6 month follow up.)
  • Problem Areas in Diabetes(Collected at Baseline, 3 month, and 6 month follow up.)
  • Acts of Daily Living(Collected at Baseline, 3 month, and 6 month follow up.)
  • Social Network Scale(Collected at Baseline, 3 month, and 6 month follow up.)

Study Sites (2)

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