Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06336122

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barren River Area Development District, Bowling Green, Kentucky, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Coach Training - Weekly

Behavioral

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

Peer Coach Training - Biweekly

Behavioral

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

Primary outcomes

  1. Number of participants with change in A1c

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

    Obtained using point of care assessment

Secondary outcomes

  1. Diabetes Empowerment

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

    "Attitudes Towards Diabetes - DES". 5 point scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", where lower scores indicate greater feelings of empowerment.

  2. Quality of Life Index

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

    "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.

  3. Social Support

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

    "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.

  4. Depression Scale

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

    "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.

  5. Problem Areas in Diabetes

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

    "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.

  6. Diabetes Self-Management

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

    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.

  7. Acts of Daily Living

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

    "Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L) is a binary where "0" is low functioning and "1" is high functioning. Higher scores indicate higher functioning

  8. Social Network Scale

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

    "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.

  9. Diabetes Knowledge Questionnaire

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

    "Diabetes Knowledge Questionnaire (DKQ)" is a 24-item survey that has shown sensitivity to a diabetes knowledge intervention; additionally, it targets knowledge deficits which can be related to measurable outcomes, false statements, or common and/or serious misconceptions. Participants can select "yes", "no", or "don't know".

  10. Problem Solving Skills

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

    "Diabetes Problem-Solving Inventory (DPSI)" includes 9 items that assess how individuals living with diabetes cope with challenges of T2D-related self-care. The inventory measures three components: healthy eating, physical activity, and stress management. Overall problem-solving rating is provided on a 5-point scale from 1 "(very poor strategy)" to 5 "(excellent strategy)".

  11. Brooks Medication Adherence

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

    "Brooks Medication Adherence Scale" is a 6-item scale and is sensitive to changes in adherence due to intervention.

  12. Frailty

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

    "Pictorial Fit-Frail Scale" measures frailty phenotype using a validated assessment that characterizes frailty by exhaustion, low physical activity, weakness, and low body mass index. Individuals are characterized as frail if they have affirmative responses to 3 or 4 of the items. By identifying frailty phenotype, individuals at increased risk for adverse health outcomes can be identified, which serves as an indicator for complex patient management.

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany L. Smalls, PhD

CONTACT

[email protected]

409-772-1011

Kindness C. Akwari, MS

CONTACT

[email protected]

502-627-0591

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • Department of Health and Human Services
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: OASIS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.