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OASIS: Peer Support for T2DM in Appalachia (OASIS)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Coaching - Peer Participants A
Peer Coaching - Peer Participants B
Peer Coaching - Peer Participants C
Peer Coaching - Peer Participants D
Sponsored by
Brittany L Smalls
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Appalachian Region, Peer Influence, Diabetes Mellitus, Type 2

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barren River Area Development DistrictRecruiting
  • UK HealthCareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Peer Participants (A)

Peer Participants (B)

Peer Participants (C)

Peer Participant (D)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants with Change in A1c
Obtained using Point of Care assessment

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 31, 2023
Last Updated
October 6, 2023
Sponsor
Brittany L Smalls
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT06003634
Brief Title
OASIS: Peer Support for T2DM in Appalachia
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brittany L Smalls
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Appalachian Region, Peer Influence, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer Participants (A)
Arm Type
Experimental
Arm Description
Peer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period.
Arm Title
Peer Participants (B)
Arm Type
Experimental
Arm Description
Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted biweekly during intervention period.
Arm Title
Peer Participants (C)
Arm Type
Experimental
Arm Description
Peer participants in group C will be matched with a peer coach by study personnel, and will be contacted weekly during intervention period.
Arm Title
Peer Participant (D)
Arm Type
Experimental
Arm Description
Peer participants in group D will be matched with a peer coach by study personnel, and will be contacted biweekly during intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Peer Coaching - Peer Participants A
Intervention Description
Peer participants in group A will self select a peer coach and will be contacted weekly by peer coaches.
Intervention Type
Behavioral
Intervention Name(s)
Peer Coaching - Peer Participants B
Intervention Description
Peer participants in group B will self select a peer coach and will be contacted bi-weekly by peer coaches.
Intervention Type
Behavioral
Intervention Name(s)
Peer Coaching - Peer Participants C
Intervention Description
Peer participants in group C will be matched with a peer coach and will be contacted weekly by peer coaches.
Intervention Type
Behavioral
Intervention Name(s)
Peer Coaching - Peer Participants D
Intervention Description
Peer participants in group D will be matched with a peer coach and will be contacted bi-weekly by peer coaches.
Primary Outcome Measure Information:
Title
Number of Participants with Change in A1c
Description
Obtained using Point of Care assessment
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Secondary Outcome Measure Information:
Title
Diabetes Empowerment
Description
"Attitudes Towards Diabetes- DES". 5 point scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", where lower scores indicate greater feelings of empowerment.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Quality of Life Index
Description
"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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Social Support
Description
"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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Depression Scale
Description
"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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Problem Areas in Diabetes
Description
"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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Diabetes Self-Management
Description
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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Acts of Daily Living
Description
"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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.
Title
Social Network Scale
Description
"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.
Time Frame
Collected at Baseline, 3 month, and 6 month follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany L Smalls, PhD
Phone
859-323-4916
Email
Brittany.Smalls@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe M Taylor, MSPH
Phone
859-562-0757
Email
Zoe.Taylor@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany L Smalls, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barren River Area Development District
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hines
Phone
270-306-4036
Email
michelle@bradd.org
Facility Name
UK HealthCare
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kay Douthitt
Email
key.douthitt@uky.edu

12. IPD Sharing Statement

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OASIS: Peer Support for T2DM in Appalachia

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