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Care Guides in the Primary Care Office (Phase II)

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01156974
Enrollment
2135
Registered
2010-07-05
Start date
2010-07-31
Completion date
2012-04-30
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension, Congestive Heart Failure

Keywords

care management, chronic disease, outpatient

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

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.

Interventions

BEHAVIORALeducation and care guide

Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals

BEHAVIORALeducation only

patients receive education about care goals

Sponsors

Allina Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change in number of care goals metone yearPredetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.

Secondary

MeasureTime frameDescription
Kinds of patients who benefit from working with a care guideone yeardemographic, clinical, and attitudinal characteristics of patients who benefit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026