Adapting and Assessing the Feasibility of a Diabetes Self-management Telehealth Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04600622|
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : June 21, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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
- Average Acceptability Score [ Time Frame: 3 months ]Average acceptability score on the intervention acceptability measure
- Average Feasibility Score [ Time Frame: 3 months ]Average feasibility score on the feasibility measure
- Change in glycosylated hemoglobin A1C [ Time Frame: Baseline to 3 months ]Physiologic measurement
- Change in diabetes distress score [ Time Frame: Baseline to 3 months ]The patient reported, 20-item, Problem Areas in Diabetes survey will be used.
- 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.
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
|Contact: Julie Neuberger, BSfirstname.lastname@example.org|
|Contact: Kristen Curcija, MPHemail@example.com|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Denver, Colorado, United States, 80204|
|Contact: Tamara Oser, MD 303-724-2060 firstname.lastname@example.org|
|Principal Investigator: Tamara Oser, MD|
|Principal Investigator:||Michelle L Litchman, PhD||University of Utah College of Nursing|
|Principal Investigator:||Tamara K Oser, MD||University of Colorado, Denver|