Care Guides in the Primary Care Office (Phase II)

April 4, 2019 updated by: Allina Health System

Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.

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

Study Overview

Detailed Description

In a randomized parallel group multi-site trial looking at achievement of standard recommended treatment goals at baseline and one year later by 2135 patients with diabetes, hypertension, and congestive heart failure, we tested the hypothesis that adding a lay person with brief training to usual care would improve clinical outcomes. These "care guides" were culturally matched to patients served, similar to community health workers, but were located in 6 diverse primary care health clinics where they could meet patients face-to-face. They were asked to assist communication in both directions between providers and patients, taking advantage of their status as non-authority figures. They were given two weeks' training about these diseases and behavior change theory. This intervention was designed to be low cost, easy to implement, and to integrate into rather than change clinic work flow.

Study Type

Interventional

Enrollment (Actual)

2135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • unable to understand randomization process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: care guide
patients receive education about care goals and work with a care guide to achieve goals
Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals
Other Names:
  • Active care management
Active Comparator: no care guide
patients receive education about care goals and usual care to achieve goals
patients receive education about care goals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinds of patients who benefit from working with a care guide
Time Frame: one year
demographic, clinical, and attitudinal characteristics of patients who benefit
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard F Adair, MD, Allina Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3096-1E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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