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

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ClinicalTrials.gov Identifier: NCT04600622
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : June 21, 2021
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Michelle Litchman, University of Utah

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabete Mellitus Behavioral: Rural Diabetes One-Day Education and Care program (R-D1D) Behavioral: Diabetes Education Materials Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 17, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600622


Contacts
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Contact: Julie Neuberger, BS 801-587-3930 julie.neuberger@hsc.utah.edu
Contact: Kristen Curcija, MPH 303-724-9502 kristen.curcija@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Tamara Oser, MD    303-724-2060    tamara.oser@cuanschutz.edu   
Principal Investigator: Tamara Oser, MD         
Sponsors and Collaborators
University of Utah
University of Colorado, Denver
Investigators
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Principal Investigator: Michelle L Litchman, PhD University of Utah College of Nursing
Principal Investigator: Tamara K Oser, MD University of Colorado, Denver
More Information
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Responsible Party: Michelle Litchman, Assistant Profesor, University of Utah
ClinicalTrials.gov Identifier: NCT04600622    
Other Study ID Numbers: 00133179
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Litchman, University of Utah:
diabetes
telehealth
rural
 Spanish
English
community based participatory research
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases