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Completed

NCT Number: NCT01156974

Care Guides in the Primary Care Office (Phase II)

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

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Key information

Conditions

Diabetes Cardiovascular Diseases Chronic Disease Congestive Heart Failure Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allina Hospitals and Clinics

Minneapolis, Minnesota, 55407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • pregnant
  • unable to understand randomization process

Treatment and study plan

education and care guide

Behavioral

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

Education only

Behavioral

patients receive education about care goals

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 5, 2010
Registry last updated
Apr 8, 2019

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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