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

NCT06336122 | Recruiting

• 2 other identifiers: 25-0304_1R01DK135885-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Appalachian Region; Peer Influence; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (12)

• Diabetes Empowerment

  Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.

• Quality of Life Index

  Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.

• Social Support

  Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.

• Depression Scale

  Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.

• Problem Areas in Diabetes

  Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.

Study Arms (4)

Peer Participant Group A

OTHER

Participants will self-select their peer coach and will receive contact once a week.

Behavioral: Peer Coach Training - Weekly

Peer Participant Group B

OTHER

Participants will self-selected their peer coach and will receive contact every 2 weeks

Behavioral: Peer Coach Training - Biweekly

Peer Participant Group C

OTHER

Participants will be matched with a peer coach and will receive contact once a week

Behavioral: Peer Coach Training - Weekly

Peer Participant Group D

OTHER

Participants will be matched with a peer coach and will receive contact every 2 weeks.

Behavioral: Peer Coach Training - Biweekly

Interventions

Peer Coach Training - Weekly BEHAVIORAL

Peer participants will be contacted by peer coaches on a weekly basis.

Peer Participant Group A; Peer Participant Group C

Peer Coach Training - Biweekly BEHAVIORAL

Peer participants will be contacted by peer coaches on a bi-weekly basis

Peer Participant Group B; Peer Participant Group D

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Health and Human Services: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• The University of Texas Medical Branch, Galveston: lead

Study Sites (2)

Barren River Area Development District

Bowling Green, Kentucky, 42101, United States

RECRUITING

UK HealthCare

Hazard, Kentucky, 41701, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Brittany L. Smalls, PhD

  University of Texas Medial Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany L. Smalls, PhD

CONTACT

409-772-1011; blsmalls@utmb.edu

Kindness C. Akwari, MS

CONTACT

502-627-0591; kcakwari@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: November 20, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (2)