Care Guides in the Primary Care Office (Phase II)

This study has been completed.
Information provided by (Responsible Party):
Richard Adair, MD, Allina Hospitals and Clinics Identifier:
First received: July 2, 2010
Last updated: January 14, 2015
Last verified: January 2015
Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals

Condition Intervention Phase
Congestive Heart Failure
Behavioral: education and care guide
Behavioral: education only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.

Resource links provided by NLM:

Further study details as provided by Allina Hospitals and Clinics:

Primary Outcome Measures:
  • change in number of care goals met [ Time Frame: one year ] [ Designated as safety issue: No ]
    Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.

Secondary Outcome Measures:
  • Kinds of patients who benefit from working with a care guide [ Time Frame: one year ] [ Designated as safety issue: No ]
    demographic, clinical, and attitudinal characteristics of patients who benefit

Enrollment: 2135
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: care guide
patients receive education about care goals and work with a care guide to achieve goals
Behavioral: education and care guide
Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals
Other Name: Active care management
Active Comparator: no care guide
patients receive education about care goals and usual care to achieve goals
Behavioral: education only
patients receive education about care goals


Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ages 18-79
  • diagnoses of diabetes, hypertension, and/or congestive heart failure

Exclusion Criteria:

  • pregnant
  • unable to understand randomization process
  Contacts and Locations
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Please refer to this study by its identifier: NCT01156974

United States, Minnesota
Allina Hospitals and Clinics
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Allina Hospitals and Clinics
Principal Investigator: Richard F Adair, MD Allina Hospitals and Clinics
  More Information

Responsible Party: Richard Adair, MD, Adjunct Professor of Medicine, University of Minnesota, Allina Hospitals and Clinics Identifier: NCT01156974     History of Changes
Other Study ID Numbers: 3096-1E 
Study First Received: July 2, 2010
Last Updated: January 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Allina Hospitals and Clinics:
care management
chronic disease

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on May 30, 2016