Care Guides in the Primary Care Office (Phase II)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Allina Hospitals and Clinics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Richard Adair, MD, Allina Hospitals and Clinics
ClinicalTrials.gov Identifier:
NCT01156974
First received: July 2, 2010
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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
Diabetes
Hypertension
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
Estimated Study Completion Date: October 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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Adair R, Christianson J, Wholey DR, White K, Town R, Lee S, Britt H, Lund P, Lukasewycz A, Elumba D. Care Guides. Employing nonclinical laypersons to help primary care teams manage chronic disease. J Ambulatory Care Manage 35(1):27-37, 2012.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: July 2, 2010
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014