Diabetes Mellitus, Type 2
Conditions
Keywords
Appalachian Region, Peer Influence, Diabetes Mellitus, Type 2
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.
Interventions
BEHAVIORALPeer Coach Training - Weekly
Peer participants will be contacted by peer coaches on a weekly basis.
BEHAVIORALPeer Coach Training - Biweekly
Peer participants will be contacted by peer coaches on a bi-weekly basis
Sponsors
The University of Texas Medical Branch, Galveston
Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with change in A1c | 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
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Empowerment | 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. |
| Quality of Life Index | 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. |
| Social Support | 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. |
| Depression Scale | 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. |
| Problem Areas in Diabetes | 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. |
| Diabetes Self-Management | 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. |
| Acts of Daily Living | 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 |
| Social Network Scale | 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. |
| Diabetes Knowledge Questionnaire | 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". |
| Problem Solving Skills | 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)". |
| Brooks Medication Adherence | 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. |
| Frailty | 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. |
Countries
United States
Contacts
CONTACTBrittany L. Smalls, PhD
CONTACTKindness C. Akwari, MS
PRINCIPAL_INVESTIGATORBrittany L. Smalls, PhD
University of Texas Medial Branch
Outcome results
None listed