OASIS: Peer Support for T2DM in Appalachia

Sponsor
Brittany L Smalls (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003634
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
108
4
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Coaching - Peer Participants A
  • Behavioral: Peer Coaching - Peer Participants B
  • Behavioral: Peer Coaching - Peer Participants C
  • Behavioral: Peer Coaching - Peer Participants D
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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.
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peer Participants (A)

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

Experimental: Peer Participants (B)

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

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

Experimental: Peer Participants (C)

Peer participants in group C will be matched with a peer coach by study personnel, and will be contacted weekly during intervention period.

Behavioral: Peer Coaching - Peer Participants C
Peer participants in group C will be matched with a peer coach and will be contacted weekly by peer coaches.

Experimental: Peer Participant (D)

Peer participants in group D will be matched with a peer coach by study personnel, and will be contacted biweekly during intervention period.

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

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Change in A1c [Collected at Baseline, 3 month, and 6 month follow up.]

    Obtained using Point of Care assessment

Secondary Outcome Measures

  1. Diabetes Empowerment [Collected at Baseline, 3 month, and 6 month follow up.]

    "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 [Collected at Baseline, 3 month, and 6 month follow up.]

    "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 [Collected at Baseline, 3 month, and 6 month follow up.]

    "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 [Collected at Baseline, 3 month, and 6 month follow up.]

    "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 [Collected at Baseline, 3 month, and 6 month follow up.]

    "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 [Collected at Baseline, 3 month, and 6 month follow up.]

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

    "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.

  8. Social Network Scale [Collected at Baseline, 3 month, and 6 month follow up.]

    "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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age greater than or equal to 55 years

  • Resident in Rural Kentucky

  • Positive diagnosis of Type 2 Diabetes Mellitus

  • HbA1c greater than 7.5 for peer participants

  • HbA1c less than 7.5 for peer coaches

  • 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

  • Cognitive Impairment

  • Non-English Speaking

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brittany L Smalls
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Brittany L Smalls, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brittany L Smalls, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT06003634
Other Study ID Numbers:
  • 83904
  • R01DK135885-01
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brittany L Smalls, Associate Professor, University of Kentucky
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023