Diabetes MellitusNCT03868813
An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)
An observational study of Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Semi-structured Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Health Coaches Group:
- 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):
- age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Semi-structured Interview
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured InterviewBehavioural
One-on-one semi-structured interviews
| Study group | Role | What they receive |
|---|---|---|
| Interview with People with Diabetes | One-on-One interview with people with diabetes Receives: Behavioral: Semi-structured Interview | |
| Interview with Health Coaches | One-on-One interview with health coaches Receives: Behavioral: Semi-structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Users' Expectation from a Health Coaching System
This interview with participants help produce knowledge on the users' expectations from a health coaching system
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanraj Thirumalai, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868813
- Sponsor's protocol ID
- UAB-DRC-2019-1
- Status last verified
- Sep 2021
- First submitted
- 5 Mar 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)
- ClinicalTrials.gov ID
- NCT03868813
- Acronym / sponsor ID
- UAB-DRC-2019-1
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interview with People with Diabetes | – | Behavioral: Semi-structured InterviewOne-on-One interview with people with diabetes |
| Interview with Health Coaches | – | Behavioral: Semi-structured InterviewOne-on-One interview with health coaches |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age between 18 and 80 years (ii) fluent in English (iii) work in or carry expertise in physical activity, nutrition/diet or health behavior.
- age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured InterviewOne-on-one semi-structured interviews | Behavioural | Interview with Health Coaches, Interview with People with Diabetes |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Users' Expectation from a Health Coaching System (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.