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Adapting and Assessing the Feasibility of a Diabetes Self-management Telehealth Intervention

Adapting and Assessing the Feasibility of a Diabetes Self-management Education and Support Telehealth Intervention for Rural Populations to Reduce Disparities in Diabetes Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04600622
Enrollment
67
Registered
2020-10-23
Start date
2021-06-17
Completion date
2022-08-24
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes, telehealth, rural, Spanish, English, community based participatory research

Brief summary

The proposed project will use community based participatory research to adapt an existing diabetes self-management and education intervention with a telehealth intervention to be culturally relevant for rural English- and Spanish-speaking populations. Participants and care partners will receive a one-time, 5.5-hour telehealth intervention from a multidisciplinary team specializing in diabetes. The overarching aim of this study is to provide a sustainable model to provide diabetes specialty care to rural populations.

Detailed description

Diabetes prevalence is higher in rural areas that have lower resources to diabetes self-management education and support (DSMES), a cornerstone to optimal diabetes management. A time efficient DSMES program delivered via telehealth by multidisciplinary experts that also encourages care partner and peer support is a creative solution to increasing access to DSMES and reducing disparities. This study is guided by the Research, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. English and Spanish-speaking participants and care partners will receive a one-time, 8-hour telehealth intervention at the rural clinic where they receive their usual care, from the multidisciplinary team. The rural clinical practices will provide feedback in two rounds, with iterative practice-level changes, to address process and/or workflow issues. Our overall objective is to adapt, implement, refine, and evaluate a time efficient DSMES program delivered via telehealth by a team of multidisciplinary experts that encourages care partner and peer support to improve A1C and diabetes self-management in rural communities to reduce disparities. Our multidisciplinary team includes researchers and clinical healthcare providers with experience in diabetes care, DSMES delivery, community-engaged research, practice-based research, and rural health issues. The University of Utah and High Plains Research Network provide a strong environment for this particular study. The proposed study will 1) adapt the exiting Diabetes One-Day Program (D1D) for use in rural communities (Rural Diabetes One-Day Program or R-D1D), 2) conduct a patient-level pilot RCT to examine effects of R-D1D (intervention group) versus standard patient education (attention control group), guided by the RE-AIM framework. Our ultimate goal is to reduce health disparities in rural populations by increasing access to diabetes specialty care using telehealth. Preliminary data support the D1D intervention, but will require adaptation to translate for rural populations, then iterative refinement at the practice level to support long-term maintenance. Such a tested, accepted intervention should have a beneficial effect on diabetes self-management across multiple rural locations.

Interventions

BEHAVIORALRural Diabetes One-Day Education and Care program (R-D1D)

One time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth.

BEHAVIORALDiabetes Education Materials

Diabetes Education Materials

Sponsors

University of Colorado, Denver
CollaboratorOTHER
University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Have a known diagnosis of type 1 or 2 diabetes with any A1C level * 18 years old or older * Live in a rural eastern Colorado * Speak and understand English or Spanish * Willing to participate in a telehealth intervention at the clinic where they usually receive care or in their own home if an in-person meeting is prohibited due to the pandemic

Exclusion criteria

* Are participating in another diabetes study * Significant cognitive impairment * Pregnant or planning to become pregnant as diabetes management recommendations are different in pregnancy * Life expectancy of \<6 months * Plan to move during the time of the study

Design outcomes

Primary

MeasureTime frameDescription
Average Acceptability Score3 monthsAverage acceptability score on the intervention acceptability measure
Average Feasibility Score3 monthsAverage feasibility score on the feasibility measure

Secondary

MeasureTime frameDescription
Change in glycosylated hemoglobin A1CBaseline to 3 monthsPhysiologic measurement
Change in diabetes distress scoreBaseline to 3 monthsThe patient reported, 20-item, Problem Areas in Diabetes survey will be used.
Change in Family and Friend Involvement in Diabetes scoreBaseline to 3 monthsThe patient reported, 16-item, Family and Friend Involvement in Diabetes survey will be used.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026