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Care Guides in the Primary Care Office (Phase II)

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ClinicalTrials.gov Identifier: NCT01156974
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Richard Adair, MD, Allina Hospitals and Clinics

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Hypertension Congestive Heart Failure Behavioral: education and care guide Behavioral: education only Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
Study Start Date : July 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. change in number of care goals met [ Time Frame: one year ]
    Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.


Secondary Outcome Measures :
  1. Kinds of patients who benefit from working with a care guide [ Time Frame: one year ]
    demographic, clinical, and attitudinal characteristics of patients who benefit



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • unable to understand randomization process

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156974


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

Publications of Results:
Responsible Party: Richard Adair, MD, Adjunct Professor of Medicine, University of Minnesota, Allina Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT01156974     History of Changes
Other Study ID Numbers: 3096-1E
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015

Keywords provided by Richard Adair, MD, Allina Hospitals and Clinics:
care management
chronic disease
outpatient

Additional relevant MeSH terms:
Heart Failure
Chronic Disease
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes