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

Diabetes Mellitus, Type 2 Clinical Trial

— OASIS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336122
• Other study ID #: 83904_1
• Secondary ID: R01DK135885-01
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: Brittany L Smalles, PhD
• Phone: 859-323-4916
• Email: Brittany.Smalls[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Barren River Area Development District	Bowling Green	Kentucky
United States	UK HealthCare	Hazard	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Kentucky	Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with change in A1c	Obtained using point of care assessment	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Diabetes Empowerment	"Attitudes Towards Diabetes- DES". 5 point scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", where lower scores indicate greater feelings of empowerment.	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Quality of Life Index	"EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL.; "EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL.; "EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL.; "EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL.	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Social Support	"MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support.; "MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support.; "MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support.; "MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support.	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Depression Scale	"Geriatric Depression Scale: Short Form" is a binary survey where participants can select "yes" or "no". Each "yes" is a singular point, if a score >5 points it is suggestive about depression and warrant a follow-up comprehensive assessment. A score of greater than or equal to 10 is almost always indicative of depression.	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Problem Areas in Diabetes	"Problem Areas In Diabetes (PAID) Scale" a five point scale ranging from 0 "not a problem" to 4 "serious problem", where a higher score indicates more problems in diabetes management.	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Diabetes Self-Management	Diabetes Self-Management Questionnaire (DSMQ) is a four point scale ranging from 0 "does not apply to me" to 3 "applies to me very much". Higher scores indicate better diabetes management.	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Acts of Daily Living	"Lawton-Brody Instrumental Activities of Daily Living Scale (L.A.D.L) is a binary where "0" is low functioning and "1" is high functioning. Higher scores indicate higher functioning	Collected at Baseline, 3 month, and 6 month follow up.
Secondary	Social Network Scale	"Lubbens Social Network Scale - 6 (LSNS-6) is a five point scale ranging from "0" none to "5" nine or more. Higher scores indicate greater amount of social support.	Collected at Baseline, 3 month, and 6 month follow up.