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

NCT ID: NCT04600622

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2022-08-24

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Active Comparator

Participants will receive diabetes education materials.

Group Type: ACTIVE_COMPARATOR

Diabetes Education Materials

Intervention Type: BEHAVIORAL

Diabetes Education Materials

Interventions

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.

Intervention Type: BEHAVIORAL

Diabetes Education Materials

Diabetes Education Materials

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Michelle Litchman

Assistant Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle L Litchman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah College of Nursing

Tamara K Oser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35700026 (View on PubMed)

Other Identifiers

00133179

Identifier Type: -

Identifier Source: org_study_id