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

Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Peer Coach Training - Weekly; Behavioral: Peer Coach Training - Biweekly

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoe M Taylor, MSPH; Phone Number: 859-562-0757; Email: Zoe.Taylor@uky.edu
• Study Contact Backup: Name: Brittany L Smalles, PhD; Phone Number: 859-323-4916; Email: Brittany.Smalls@uky.edu

Study Locations

• United States
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Recruiting
      • Barren River Area Development District
      • Contact: Michelle Hines; Phone Number: 270-306-4036; Email: michelle@bradd.org
    • Hazard, Kentucky, United States, 41701
      • Recruiting
      • UK HealthCare
      • Contact: Kay Douthitt, MD; Email: key.douthitt@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Peer Participant Group A; Participants will self-select their peer coach and will receive contact once a week.	Behavioral: Peer Coach Training - Weekly; Peer participants will be contacted by peer coaches on a weekly basis.
Other: Peer Participant Group B; Participants will self-selected their peer coach and will receive contact every 2 weeks	Behavioral: Peer Coach Training - Biweekly; Peer participants will be contacted by peer coaches on a bi-weekly basis
Other: Peer Participant Group C; Participants will be matched with a peer coach and will receive contact once a week	Behavioral: Peer Coach Training - Weekly; Peer participants will be contacted by peer coaches on a weekly basis.
Other: Peer Participant Group D; Participants will be matched with a peer coach and will receive contact every 2 weeks.	Behavioral: Peer Coach Training - Biweekly; Peer participants will be contacted by peer coaches on a bi-weekly basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with change in A1c	Obtained using point of care assessment	Collected at Baseline, 3 month, and 6 month follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2; Peer Influence; Appalachian Region
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 83904_1; R01DK135885-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No