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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Rural Diabetes One-Day Education and Care program (R-D1D); Behavioral: Diabetes Education Materials

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Participants will receive Rural Diabetes One-Day Education and Care program (R-D1D). A one time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth.	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.
Active Comparator: Active Comparator; Participants will receive diabetes education materials.	Behavioral: Diabetes Education Materials; Diabetes Education Materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Acceptability Score	Average acceptability score on the intervention acceptability measure	3 months
Average Feasibility Score	Average feasibility score on the feasibility measure	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycosylated hemoglobin A1C	Physiologic measurement	Baseline to 3 months
Change in diabetes distress score	The patient reported, 20-item, Problem Areas in Diabetes survey will be used.	Baseline to 3 months
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Michelle L Litchman, PhD, University of Utah College of Nursing; Principal Investigator: Tamara K Oser, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Litchman ML, Kwan BM, Zittleman L, Simonetti J, Iacob E, Curcija K, Neuberger J, Latendress G, Oser TK. A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 14;11(6):e34255. doi: 10.2196/34255.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; Spanish; rural; community based participatory research; telehealth; English
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 00133179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No