- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003634
OASIS: Peer Support for T2DM in Appalachia (Peer Coaches) (OASIS)
March 21, 2024 updated by: Brittany L Smalls
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
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
Observational
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brittany L Smalls, PhD
- Phone Number: 859-323-4916
- Email: Brittany.Smalls@uky.edu
Study Contact Backup
- Name: Zoe M Taylor, MSPH
- Phone Number: 859-562-0757
- Email: Zoe.Taylor@uky.edu
Study Locations
-
-
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
- Email: key.douthitt@uky.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Age greater than or equal to 55 years
- Resident in Rural Kentucky
- Positive diagnosis of Type 2 Diabetes Mellitus
- HbA1c less than 7.5 for peer coaches
- Passing score on cognitive assessment administered by study personnel
- English Speaking
Description
Inclusion Criteria:
- Age greater than or equal to 55 years
- Resident in Rural Kentucky
- Positive diagnosis of Type 2 Diabetes Mellitus
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
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.
|
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.
|
Peer participants in group D will be matched with a peer coach and will be contacted bi-weekly by peer coaches.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Change in A1c
Time Frame: Collected at Baseline, 3 month, and 6 month follow up.
|
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
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Quality of Life Index
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Social Support
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Depression Scale
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Problem Areas in Diabetes
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Diabetes Self-Management
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Acts of Daily Living
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Social Network Scale
Time Frame: 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.
|
Collected at Baseline, 3 month, and 6 month follow up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brittany L Smalls, PhD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
August 14, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 83904
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Peer Coaching - Peer Participants A
-
University of California, San FranciscoAmerican Academy of Family PhysiciansCompleted
-
Duke UniversityAdult Congenital Heart AssociationActive, not recruitingCongenital Heart Disease | Congenital Heart DefectUnited States
-
Medical College of WisconsinCompleted
-
Baystate Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); University of Michigan; University... and other collaboratorsRecruitingChronic Obstructive Pulmonary DiseaseUnited States
-
Spaulding Rehabilitation HospitalDeborah Munroe Noonan Memorial Research FundActive, not recruitingCerebral Palsy | Spina BifidaUnited States
-
Georgetown UniversityRecruiting
-
Sunnybrook Health Sciences CentreCompletedCoaching | Laparoscopy | Technical Skill
-
La Trobe UniversityRecruitingAnterior Cruciate Ligament Injuries | Concussion, Brain | Musculoskeletal InjuryAustralia
-
Women's College HospitalUniversity Health Network, Toronto; Canadian Cancer Society (CCS); Public Health... and other collaboratorsRecruitingCancer | Chronic DiseaseCanada
-
VA Office of Research and DevelopmentCompletedDiabetesUnited States