Care Guides in the Primary Care Office (Phase II)

NCT01156974 | Completed Phase 2

• 1 other identifier: 3096-1E
• Study Type: interventional
• Target: 2,135
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes; Hypertension; Congestive Heart Failure

Keywords

care management; chronic disease; outpatient

Outcome Measures

Primary Outcomes (1)

• change in number of care goals met

  Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.

  one year

Secondary Outcomes (1)

• Kinds of patients who benefit from working with a care guide

  one year

Study Arms (2)

care guide

EXPERIMENTAL

patients receive education about care goals and work with a care guide to achieve goals

Behavioral: education and care guide

no care guide

ACTIVE COMPARATOR

patients receive education about care goals and usual care to achieve goals

Behavioral: education only

Interventions

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

Also known as: Active care management

care guide

education only BEHAVIORAL

patients receive education about care goals

no care guide

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant
• unable to understand randomization process

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Allina Hospitals and Clinics

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (3)

• 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 Ambul Care Manage. 2012 Jan-Mar;35(1):27-37. doi: 10.1097/JAC.0b013e31823b0fbe.

  PMID: 22156953 RESULT

• Adair R, Wholey DR, Christianson J, White KM, Britt H, Lee S. Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial. Ann Intern Med. 2013 Aug 6;159(3):176-84. doi: 10.7326/0003-4819-159-3-201308060-00007.

  PMID: 23922063 RESULT

• Wholey DR, White KM, Adair R, Christianson JB, Lee S, Elumba D. Care guides: an examination of occupational conflict and role relationships in primary care. Health Care Manage Rev. 2013 Oct-Dec;38(4):272-83. doi: 10.1097/HMR.0b013e31825f3df9.

  PMID: 22728580 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Heart Failure; Chronic Disease

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Richard F Adair, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

US (1)