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Recruiting NCT06336122

OASIS: Peer Support for T2DM in Appalachia (Peer Participant)

No phase Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer Coach Training - Weekly, Peer Coach Training - Biweekly.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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.

Overview

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.

Interventions

  • Behavioral Peer Coach Training - Weekly
    Peer participants will be contacted by peer coaches on a weekly basis.
  • Behavioral Peer Coach Training - Biweekly
    Peer participants will be contacted by peer coaches on a bi-weekly basis

Primary outcome measures

  • Number of participants with change in A1c [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
Secondary outcome measures (12)
  • Diabetes Empowerment [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Quality of Life Index [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Social Support [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Depression Scale [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Problem Areas in Diabetes [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Diabetes Self-Management [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Acts of Daily Living [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Social Network Scale [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Diabetes Knowledge Questionnaire [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Problem Solving Skills [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Brooks Medication Adherence [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Frailty [Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • Barren River Area Development District — Bowling Green
  • UK HealthCare — Hazard

Identifiers

NCT: NCT06336122 · 25-0304_1 · R01DK135885-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗