- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868813
An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)
September 22, 2021 updated by: Mohanraj Thirumalai, University of Alabama at Birmingham
This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
There will be a total of two 2 groups - one group comprising of 10 health experts and another group 2comprising of 10 patient/caregiver dyads (20 people).
There is no treatment or intervention offered, only the interview questionnaire will differ based on the group.
Description
Inclusion Criteria:
Health Coaches Group:
(i) age between 18 and 80 years (ii) fluent in English (iii) work in or carry expertise in physical activity, nutrition/diet or health behavior.
People with Diabetes Group (Patient/Caregiver Dyads):
(i) age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes.
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Interview with People with Diabetes
One-on-One interview with people with diabetes
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One-on-one semi-structured interviews
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Interview with Health Coaches
One-on-One interview with health coaches
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One-on-one semi-structured interviews
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Users' Expectation from a Health Coaching System
Time Frame: 60 minutes
|
This interview with participants help produce knowledge on the users' expectations from a health coaching system
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
March 5, 2019
First Submitted That Met QC Criteria
March 7, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Actual)
September 24, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAB-DRC-2019-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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