An RCT Evaluation of a Diabetes Dashboard Team Model in Primary Care

June 4, 2014 updated by: Baystate Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

399

Phase

  • Not Applicable

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

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 years or older,
  • self-identified Hispanic ethnicity,
  • diagnosis of T2D,
  • HbA1c >7.5%, and
  • provider approval given for patient participation

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dashboard team care intervention
Dashboard team
Behavioral: Diabetes Dashboard Intervention
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.
Active Comparator: usual diabetes team control
usual clinical diabetes team with no access to the diabetes dashboard
Behavioral: Usual Diabetes Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
Change in HbA1c over 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes distress
Time Frame: 6 months
Patient reported diabetes distress associated with Type 2 diabetes and its treatment measured using the PAID scale
6 months
Depression
Time Frame: 6 months
Patient-reported depression status based on the PHQ scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baystate Medical Center

Investigators

  • Principal Investigator: Garry Welch, PhD, Baystate Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetesdashboardrct

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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