NCT06003634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

July 31, 2023

Last Update Submit

March 20, 2025

Conditions

Keywords

Appalachian RegionPeer InfluenceDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Change in A1c

    Obtained using Point of Care assessment

    Collected at Baseline, 3 month, and 6 month follow up.

Secondary Outcomes (8)

  • 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.

  • Social Support

    Collected at Baseline, 3 month, and 6 month follow up.

  • Depression Scale

    Collected at Baseline, 3 month, and 6 month follow up.

  • Problem Areas in Diabetes

    Collected at Baseline, 3 month, and 6 month follow up.

  • +3 more secondary outcomes

Study Arms (4)

Peer Participants (A)

EXPERIMENTAL

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

Peer Participants (B)

EXPERIMENTAL

Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period.

Behavioral: Peer Coaching - Peer Participants B

Peer Participants (C)

EXPERIMENTAL

Peer participants in group C will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period.

Behavioral: Peer Coaching - Peer Participants C

Peer Participants (D)

EXPERIMENTAL

Peer participants in group D will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period.

Behavioral: Peer Coaching - Peer Participants D

Interventions

Peer participants in group A will self select a peer coach and will be contacted weekly by peer coaches.

Peer Participants (A)

Peer participants in group B will self select a peer coach and will be contacted bi-weekly by peer coaches.

Peer Participants (B)

Peer participants in group C will be matched with a peer coach and will be contacted weekly by peer coaches.

Peer Participants (C)

Peer participants in group D will be matched with a peer coach and will be contacted bi-weekly by peer coaches.

Peer Participants (D)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 less than 7.5 for peer coaches
  • 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
  • Cognitive Impairment
  • Non-English Speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barren River Area Development District

Bowling Green, Kentucky, 42101, United States

RECRUITING

UK HealthCare

Hazard, Kentucky, 41701, United States

RECRUITING

Related Publications (1)

  • Smalls BL, Kruse-Diehr A, Ortz CL, Douthitt K, McLouth C, Shelton R, Taylor Z, Williams E. Older adults using social support to improve self-care (OASIS): Adaptation, implementation and feasibility of peer support for older adults with T2D in appalachia: A feasibility study protocol. PLoS One. 2024 Mar 18;19(3):e0300196. doi: 10.1371/journal.pone.0300196. eCollection 2024.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Brittany L Smalls, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin Jacobs, PhD

CONTACT

Austin P Jacobs, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 22, 2023

Study Start

November 20, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations