Testing New Models of Diabetes Self-Management to Improve Population Health
NCT ID: NCT06370494
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
191 participants
INTERVENTIONAL
2019-02-01
2022-03-31
Brief Summary
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Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.
These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Virtual Making Moves with Diabetes [MMWD] Group
Virtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups.
Living Healthier with Diabetes
Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.
App Group
Smartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
Living Healthier with Diabetes
Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.
Combo Group
A combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
Living Healthier with Diabetes
Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.
Interventions
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Living Healthier with Diabetes
Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.
Eligibility Criteria
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Inclusion Criteria
* HbA1c value greater than or equal to 7.5%
* Adults ages 25 years and older
* All genders
* Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
* Ability to read and speak English
* Resides in Texas
Exclusion Criteria
* Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
* Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
* Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
* Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.
25 Years
ALL
Yes
Sponsors
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Blue Cross Blue Shield
OTHER
Texas A&M University
OTHER
Responsible Party
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Marcia G Ory
Regents and Distinguished Professor
Principal Investigators
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Marcia Ory
Role: PRINCIPAL_INVESTIGATOR
Texas A&M Health
Locations
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Texas A&M Health
College Station, Texas, United States
Countries
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Other Identifiers
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IRB2020-0956D
Identifier Type: -
Identifier Source: org_study_id
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