Diabetes Mellitus, Type 2OASISNCT06003634
OASIS: Peer Support for T2DM in Appalachia (Peer Coaches)
A study testing Peer Coaching - Peer Participants A, Peer Coaching - Peer Participants B and Peer Coaching - Peer Participants C in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Peer Coaching - Peer Participants A, Peer Coaching - Peer Participants B and Peer Coaching - Peer Participants C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 55 years
- Not a resident of a Rural Kentucky County
- No Type 2 Diabetes Mellitus Diagnosis
- Cognitive Impairment
- Non-English Speaking
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Barren River Area Development District
Bowling Green, Kentucky, 42101
Alecia Johnson, 270-781-2381, alecia.johnson@bradd.org
- Recruiting
UK HealthCare
Hazard, Kentucky, 41701
Key Douthitt, MD, 606-439-1559, key.douthitt@uky.edu
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Peer Coaching - Peer Participants A, Peer Coaching - Peer Participants B, Peer Coaching - Peer Participants C, Peer Coaching - Peer Participants D
- Keywords
- Appalachian Region, Peer Influence, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Coaching - Peer Participants ABehavioural
Peer participants in group A will be contacted by peer coaches on a weekly basis.
Peer Coaching - Peer Participants BBehavioural
Peer participants in group B will be contacted by peer coaches on a bi-weekly basis.
Peer Coaching - Peer Participants CBehavioural
Peer participants in group C will be contacted by peer coaches on a weekly basis.
Peer Coaching - Peer Participants DBehavioural
Peer participants in group D will be contacted by peer coaches on a bi-weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Peer Participants (A) | Experimental | Peer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during the intervention period. Receives: Behavioral: Peer Coaching - Peer Participants A |
| Peer Participants (B) | Experimental | Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted every 2 weeks during the intervention period. Receives: Behavioral: Peer Coaching - Peer Participants B |
| Peer Participants (C) | Experimental | Peer participants in group C will be matched with a peer coach and will be contacted weekly during the intervention period. Receives: Behavioral: Peer Coaching - Peer Participants C |
| Peer Participants (D) | Experimental | Peer participants in group D will be matched with a peer coach and will be contacted every 2 weeks during the intervention period. Receives: Behavioral: Peer Coaching - Peer Participants D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Change in A1c
Obtained using point of care assessment
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Secondary outcomes (12)
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Acts of Daily Living
"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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Diabetes Knowledge Questionnaire
"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".
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Problem Solving Skills
"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)".
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Brooks Medication Adherence
"Brooks Medication Adherence Scale" is a 6-item scale and is sensitive to changes in adherence due to intervention.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Frailty
"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.
Measured: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start20 Nov 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brittany L. Smalls, PhD, Principal investigator, University of Texas Medial Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003634
- Sponsor's protocol ID
- 25-0304
- Other IDs
- R01DK135885-01
- Acronym
- OASIS
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smalls BL, Kruse-Diehr A, Ortz CL, Douthitt K, McLouth C, Shelton R, Taylor Z, Williams E. Older adults using social support to improve self-care (OASIS): Adaptation, implementation and feasibility of peer support for older adults with T2D in appalachia: A feasibility study protocol. PLoS One. 2024 Mar 18;19(3):e0300196. doi: 10.1371/journal.pone.0300196. eCollection 2024.
PubMed 38498512
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06003634
- Acronym / sponsor ID
- OASIS / 25-0304
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Appalachian Region, Peer Influence, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peer Participants (A) | Experimental | Behavioral: Peer Coaching - Peer Participants APeer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during the intervention period. |
| Peer Participants (B) | Experimental | Behavioral: Peer Coaching - Peer Participants BPeer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted every 2 weeks during the intervention period. |
| Peer Participants (C) | Experimental | Behavioral: Peer Coaching - Peer Participants CPeer participants in group C will be matched with a peer coach and will be contacted weekly during the intervention period. |
| Peer Participants (D) | Experimental | Behavioral: Peer Coaching - Peer Participants DPeer participants in group D will be matched with a peer coach and will be contacted every 2 weeks during the intervention period. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Age less than 55 years
- Not a resident of a Rural Kentucky County
- No Type 2 Diabetes Mellitus Diagnosis
- Cognitive Impairment
- Non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Coaching - Peer Participants APeer participants in group A will be contacted by peer coaches on a weekly basis. | Behavioural | Peer Participants (A) |
| Peer Coaching - Peer Participants BPeer participants in group B will be contacted by peer coaches on a bi-weekly basis. | Behavioural | Peer Participants (B) |
| Peer Coaching - Peer Participants CPeer participants in group C will be contacted by peer coaches on a weekly basis. | Behavioural | Peer Participants (C) |
| Peer Coaching - Peer Participants DPeer participants in group D will be contacted by peer coaches on a bi-weekly basis. | Behavioural | Peer Participants (D) |
Primary outcome
Number of Participants with Change in A1c
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Obtained using point of care assessment
12 secondary outcomes
Diabetes Empowerment
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Quality of Life Index
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Social Support
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Depression Scale
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Problem Areas in Diabetes
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Diabetes Self-Management
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Acts of Daily Living
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Social Network Scale
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Diabetes Knowledge Questionnaire
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Problem Solving Skills
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Brooks Medication Adherence
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Frailty
Time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 38498512Smalls BL, Kruse-Diehr A, Ortz CL, Douthitt K, McLouth C, Shelton R, Taylor Z, Williams E. Older adults using social support to improve self-care (OASIS): Adaptation, implementation and feasibility of peer support for older adults with T2D in appalachia: A feasibility study protocol. PLoS One. 2024 Mar 18;19(3):e0300196. doi: 10.1371/journal.pone.0300196. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brittany L. Smalls, PhD principal investigator
University of Texas Medial Branch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Coaching - Peer Participants A, Peer Coaching - Peer Participants B and Peer Coaching - Peer Participants C in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany L. Smalls, PhD (409-772-1011, blsmalls@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Change in A1c (time frame: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.