DiabetesDSMSNCT02746861
Peer-Supported Diabetes Self-Management Support
A study testing Peer-Supported DSMS in people with Diabetes, run by InquisitHealth, Inc. at 1 site in United States.
Trial summary
The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Peer-Supported DSMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- HbA1c>9%
- African American or Hispanic ethnicity
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ashwin Patel, MD PhD contact
United States1 site, 1 recruiting
- Recruiting
InquisitHealth
River Edge, New Jersey, 07661
Ashwin Patel, 855-412-1787
About this study
Official title: Web-based Training of Peers to Deliver Diabetes Self-Management Support
The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.
- Conditions
- Diabetes
- Being tested
- Peer-Supported DSMS
- Keywords
- peer mentor, peer supporter, peer coach, peer-to-peer mentoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Supported DSMSBehavioural
Phone, SMS/text, and smartphone-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Self-Management Support (DSMS) | Experimental | Patient receives 6-months of DSMS while receiving support from a trained peer mentor (Peer-supported DSMS). Receives: Behavioral: Peer-Supported DSMS |
| Usual Care | No intervention | Patient continues to receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average reduction in HbA1c from baseline
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InquisitHealth, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ashwin Patel, InquisitHealth, Inc.
- Investigators
- Ashwin Patel, MD PhD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746861
- Sponsor's protocol ID
- DSMS24
- Other IDs
- 5R43MD009555
- Acronym
- DSMS
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Training of Peers to Deliver Diabetes Self-Management Support
- ClinicalTrials.gov ID
- NCT02746861
- Acronym / sponsor ID
- DSMS / DSMS24
- Conditions
- Diabetes
- Keywords
- peer mentor, peer supporter, peer coach, peer-to-peer mentoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- InquisitHealth, Inc.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- 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.
The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Self-Management Support (DSMS) | Experimental | Behavioral: Peer-Supported DSMSPatient receives 6-months of DSMS while receiving support from a trained peer mentor (Peer-supported DSMS). |
| Usual Care | No intervention | –Patient continues to receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- HbA1c>9%
- African American or Hispanic ethnicity
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Peer-Supported DSMSPhone, SMS/text, and smartphone-based intervention. | Behavioural | Diabetes Self-Management Support (DSMS) |
Primary outcome
Average reduction in HbA1c from baseline
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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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.
Ashwin Patel, MD PhD contact
Ashwin Patel, MD PhD principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Supported DSMS in people with Diabetes, run by InquisitHealth, Inc. 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 21 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashwin Patel, MD PhD (855-412-1787), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average reduction in HbA1c from baseline (time frame: 6-months). 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 21 Apr 2016.