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Completed

NCT Number: NCT04600622

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Diabetes Education Materials

Behavioral

Diabetes Education Materials

Primary outcomes

  1. Average Acceptability Score

    Time frame: 3 months

    Average acceptability score on the intervention acceptability measure

  2. Average Feasibility Score

    Time frame: 3 months

    Average feasibility score on the feasibility measure

Secondary outcomes

  1. Change in glycosylated hemoglobin A1C

    Time frame: Baseline to 3 months

    Physiologic measurement

  2. Change in diabetes distress score

    Time frame: Baseline to 3 months

    The patient reported, 20-item, Problem Areas in Diabetes survey will be used.

  3. Change in Family and Friend Involvement in Diabetes score

    Time frame: Baseline to 3 months

    The patient reported, 16-item, Family and Friend Involvement in Diabetes survey will be used.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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