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

Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600622
• Other study ID #: 00133179
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: August 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 24, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Rural 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.
• Diabetes Education Materials
Diabetes Education Materials

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Acceptability Score	Average acceptability score on the intervention acceptability measure	3 months
Primary	Average Feasibility Score	Average feasibility score on the feasibility measure	3 months
Secondary	Change in glycosylated hemoglobin A1C	Physiologic measurement	Baseline to 3 months
Secondary	Change in diabetes distress score	The patient reported, 20-item, Problem Areas in Diabetes survey will be used.	Baseline to 3 months
Secondary	Change in Family and Friend Involvement in Diabetes score	The patient reported, 16-item, Family and Friend Involvement in Diabetes survey will be used.	Baseline to 3 months