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OpenTrials
Completed

NCT Number: NCT02156037

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes Dashboard Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. HbA1c

    Time frame: 6 months

    Change in HbA1c over 6 months

Secondary outcomes

  1. Diabetes distress

    Time frame: 6 months

    Patient reported diabetes distress associated with Type 2 diabetes and its treatment measured using the PAID scale

  2. Depression

    Time frame: 6 months

    Patient-reported depression status based on the PHQ scale

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Registry information

Official study title

Case Management for Underserved Hispanic Type 2 Diabetes Populations

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2014
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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