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

NCT ID: NCT06336122

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Peer Participant Group A

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

Group Type OTHER

Peer Coach Training - Weekly

Intervention Type BEHAVIORAL

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

Peer Participant Group B

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

Group Type OTHER

Peer Coach Training - Biweekly

Intervention Type BEHAVIORAL

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

Peer Participant Group C

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

Group Type OTHER

Peer Coach Training - Weekly

Intervention Type BEHAVIORAL

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

Peer Participant Group D

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

Group Type OTHER

Peer Coach Training - Biweekly

Intervention Type BEHAVIORAL

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

Interventions

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Peer Coach Training - Weekly

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

Intervention Type BEHAVIORAL

Peer Coach Training - Biweekly

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Brittany L Smalls

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barren River Area Development District

Bowling Green, Kentucky, United States

Site Status RECRUITING

UK HealthCare

Hazard, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brittany L Smalles, PhD

Role: CONTACT

859-323-4916

Zoe M Taylor, MSPH

Role: CONTACT

859-562-0757

Facility Contacts

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Michelle Hines

Role: primary

270-306-4036

Kay Douthitt, MD

Role: primary

Other Identifiers

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R01DK135885-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

83904_1

Identifier Type: -

Identifier Source: org_study_id

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