OASIS: Peer Support for T2DM in Appalachia (Peer Coaches)
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age less than 55 years
Not a resident of a Rural Kentucky County
No Type 2 Diabetes Mellitus Diagnosis
Cognitive Impairment
Trial design
Design model
Factorial
Treatments tested in this trial
Peer Coaching - Peer Participants A
BehavioralPeer participants in group A will be contacted by peer coaches on a weekly basis.
Peer Coaching - Peer Participants B
BehavioralPeer participants in group B will be contacted by peer coaches on a bi-weekly basis.
Peer Coaching - Peer Participants C
BehavioralPeer participants in group C will be contacted by peer coaches on a weekly basis.
Peer Coaching - Peer Participants D
BehavioralPeer participants in group D will be contacted by peer coaches on a bi-weekly basis.
Treatment groups
25 Participants
are divided into 4 treatment groupsGroup A: Peer Participants (A)Experimental treatment 1 intervention
Group B: Peer Participants (B)Experimental treatment 1 intervention
Group C: Peer Participants (C)Experimental treatment 1 intervention
Group D: Peer Participants (D)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Change in A1c
Obtained using point of care assessment
Time frame
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.Secondary outcomes
1
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.
Time frame
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.2
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.
Time frame
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.3
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.
Time frame
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.4
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.
Time frame
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Medical Branch, Galveston
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov