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

Diabetes Clinical Trial

Official title:

Case Management for Underserved Hispanic Type 2 Diabetes Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156037
• Other study ID #: diabetesdashboardrct
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: June 4, 2014
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c over 6 months	6 months
Secondary	Diabetes distress	Patient reported diabetes distress associated with Type 2 diabetes and its treatment measured using the PAID scale	6 months
Secondary	Depression	Patient-reported depression status based on the PHQ scale	6 months