DiabetesNCT02156037
An RCT Evaluation of a Diabetes Dashboard Team Model in Primary Care
A study testing Diabetes Dashboard Intervention and Usual Diabetes Care in people with Diabetes, run by Baystate Medical Center at 1 site in United States.
Trial summary
To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Diabetes Dashboard Intervention and Usual Diabetes Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2013
- 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
- age 18 years or older,
- self-identified Hispanic ethnicity,
- diagnosis of T2D,
- HbA1c >7.5%, and
- provider approval given for patient participation
Who cannot join
- inability to consent,
- pregnant or planning to become pregnant in the next year,
- taking glucocorticoid therapy, or
- having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Case Management for Underserved Hispanic Type 2 Diabetes Populations
To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.
Read the detailed description
To compare a usual diabetes care condition (UDC) to a comprehensive diabetes care intervention condition (IC) involving a "diabetes dashboard" clinical decision support tool used by the diabetes team in primary care. The investigators used a parallel-groups randomized design. The diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (HbA1c >7.5%) Latino T2D patients (mean age=55 years, 60% female) seen at 2 urban community health centers. This intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).
- Conditions
- Diabetes
- Being tested
- Diabetes Dashboard Intervention, Usual Diabetes Care
- Keywords
- Hispanic, clinical decision support, diabetes, Hba1c, psychosocial
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Dashboard InterventionBehavioural
The Diabetes Dashboard Intervention Condition involved a program of five, in-person, one-on-one diabetes education and behavior change visits with a diabetes nurse or diabetes dietician, scheduled at baseline, two weeks, one month, three months, and six months post-enrollment.
Usual Diabetes CareBehavioural
The UDC condition was delivered by four bicultural, bilingual diabetes nurses and diabetes dietitians who comprised the clinical site's long-standing, in-house diabetes program.
| Study group | Role | What they receive |
|---|---|---|
| dashboard team care intervention | Experimental | Dashboard team Receives: Behavioral: Diabetes Dashboard Intervention |
| usual diabetes team control | Active comparator | usual clinical diabetes team with no access to the diabetes dashboard Receives: Behavioral: Usual Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c over 6 months
Measured: 6 months
Secondary outcomes (2)
Diabetes distress
Patient reported diabetes distress associated with Type 2 diabetes and its treatment measured using the PAID scale
Measured: 6 months
Depression
Patient-reported depression status based on the PHQ scale
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 posted5 Jun 2014 (estimated)
- Study startJul 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garry Welch, PhD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156037
- Sponsor's protocol ID
- diabetesdashboardrct
- Status last verified
- Jun 2014
- First submitted
- 3 Jun 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Welch G, Zagarins SE, Santiago-Kelly P, Rodriguez Z, Bursell SE, Rosal MC, Gabbay RA. An internet-based diabetes management platform improves team care and outcomes in an urban Latino population. Diabetes Care. 2015 Apr;38(4):561-7. doi: 10.2337/dc14-1412. Epub 2015 Jan 29.
PubMed 25633661
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Management for Underserved Hispanic Type 2 Diabetes Populations
- ClinicalTrials.gov ID
- NCT02156037
- Acronym / sponsor ID
- diabetesdashboardrct
- Conditions
- Diabetes
- Keywords
- Hispanic, clinical decision support, diabetes, Hba1c, psychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Jun 2014 (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.
To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.
Detailed description
To compare a usual diabetes care condition (UDC) to a comprehensive diabetes care intervention condition (IC) involving a "diabetes dashboard" clinical decision support tool used by the diabetes team in primary care. The investigators used a parallel-groups randomized design. The diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (HbA1c >7.5%) Latino T2D patients (mean age=55 years, 60% female) seen at 2 urban community health centers. This intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dashboard team care intervention | Experimental | Behavioral: Diabetes Dashboard InterventionDashboard team |
| usual diabetes team control | Active comparator | Behavioral: Usual Diabetes Careusual clinical diabetes team with no access to the diabetes dashboard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 years or older,
- self-identified Hispanic ethnicity,
- diagnosis of T2D,
- HbA1c >7.5%, and
- provider approval given for patient participation
Key exclusion criteria (4 listed)
- inability to consent,
- pregnant or planning to become pregnant in the next year,
- taking glucocorticoid therapy, or
- having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.
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 |
|---|---|---|
| Diabetes Dashboard InterventionThe Diabetes Dashboard Intervention Condition involved a program of five, in-person, one-on-one diabetes education and behavior change visits with a diabetes nurse or diabetes dietician, scheduled at baseline, two weeks, one month, three months, and six months post-enrollment. | Behavioural | dashboard team care intervention |
| Usual Diabetes CareThe UDC condition was delivered by four bicultural, bilingual diabetes nurses and diabetes dietitians who comprised the clinical site's long-standing, in-house diabetes program. | Behavioural | usual diabetes team control |
Primary outcome
HbA1c
Time frame: 6 months
Change in HbA1c over 6 months
2 secondary outcomes
Diabetes distress
Time frame: 6 months
Depression
Time frame: 6 months
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 5 Jun 2014.
- Derived from this study: PubMed 25633661Welch G, Zagarins SE, Santiago-Kelly P, Rodriguez Z, Bursell SE, Rosal MC, Gabbay RA. An internet-based diabetes management platform improves team care and outcomes in an urban Latino population. Diabetes Care. 2015 Apr;38(4):561-7. doi: 10.2337/dc14-1412. Epub 2015 Jan 29.
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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.
Garry Welch, PhD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Dashboard Intervention and Usual Diabetes Care in people with Diabetes, run by Baystate Medical Center 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 5 inclusion and 4 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 5 Jun 2014. 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?
HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156037, which also lists 1 linked publication.
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 5 Jun 2014.