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Homing in on Health: Study of a Home Delivered Chronic Disease Self Management Program

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ClinicalTrials.gov Identifier: NCT00263939
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)

Tracking Information
First Submitted Date  ICMJE December 9, 2005
First Posted Date  ICMJE December 12, 2005
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE July 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2005)
Health related quality of life (HRQoL) at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00263939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2005)
self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Homing in on Health: Study of a Home Delivered Chronic Disease Self Management Program
Official Title  ICMJE A Randomized Trial of Home Self-Efficacy Enhancement
Brief Summary The purpose of the study is to determine the effectiveness of a home-delivered variant of the chronic disease self management program in improving health outcomes in patients with chronic conditions.
Detailed Description

Key reasons for the "quality chasm" between current and ideal chronic illness care are that our health care system is insensitive to patient preference, provider-driven, and disease-focused. By contrast, a common goal among proposed patient-centered care models is to foster continuous healing relationships between patients and the health care system. Such relationships allow patients to receive care over time via a variety of communication media, rather than just via periodic office visits. Home health care can foster such relationships and improve outcomes for patients with a variety of conditions. Home interventions may be particularly useful in caring for the growing number of people with chronic illnesses accompanied by functional limitations that reduce their access to community-based interventions such as group self-care classes. However, trials comparing the effectiveness of the wide array of home care models are limited, and the mechanisms that underlie their effectiveness remain unclear.

This randomized controlled trial (RCT) of 3 groups, comparing the effectiveness and cost-effectiveness of 2 different home-based care models and usual care in improving chronic illness outcomes, will address these research gaps. The primary outcome will be health-related quality of life (HRQoL). We will also explore the mechanisms of effectiveness of home care through its influence on self-efficacy - beliefs patients have about their ability to successfully execute the actions required to achieve valued health outcomes - and adherence. The chronic illnesses targeted will be diabetes mellitus (DM), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), asthma, arthritis, and depression. The home care delivery media in the models will be in-person visits, and standard telephone calls. The study hypotheses are: a) Each of the 3 different home interventions will result in improvements in patient self-efficacy, adherence to care, and HRQoL compared with usual care but will not differ statistically; b) From the payer's perspective, all the interventions will be cost saving compared with usual care, and a standard telephone intervention will be the most cost saving; and c) Self-efficacy will improve temporally before adherence to care and HRQoL.

The research proven framework for improving patient self-efficacy that we will employ in our interventions, the Chronic Disease Self-Management Program (CDSMP), was developed at Stanford University. It was designed to be delivered by trained laypersons to groups of patients in community settings. The CDSMP developers will serve as consultants on our study, assisting us with modifying the program for delivery by trained lay visitors to individual patients in their homes.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Congestive Heart Failure
  • Arthritis
  • COPD
  • Depression
Intervention  ICMJE Behavioral: Homing in on Health
A peer (non-health professional) delivered intervention to enhance patient self-efficacy for chronic disease self-management. Developed as a modification of the Stanford Chronic Disease Self-Management Program.
Study Arms
  • Experimental: 1 - In home intervention
    In home (face to face) delivery of the study intervention, Homing in on Health
    Intervention: Behavioral: Homing in on Health
  • Experimental: 2 - Telephone intervention
    Telephone delivery of the study intervention, Homing in on Health
    Intervention: Behavioral: Homing in on Health
  • No Intervention: 3 - Usual care
    Patients receiving the care their usual health providers supply, without an study intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2010)
415
Original Enrollment  ICMJE
 (submitted: December 9, 2005)
360
Actual Study Completion Date October 2007
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • receive primary care 1 of 12 UC Davis Primary Care Network (PCN) offices
  • live in a private home
  • age 40 or older
  • able to read and speak english
  • Adequate vision and hearing to read study materials and use a standard telephone
  • have one or more of the following conditions: arthritis, asthma, COPD, CHF, depression, DM
  • suffer functional impairment as manifest by at least one of the following: self-reported impairment in at least 1 basic activity of daily living on Health Assessment Questionnaire (HAQ); or score higher than 3 on the 10-item version of the Center for Epidemiologic Studies Depression Scale (CES-D)

Exclusion criteria: see above

Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00263939
Other Study ID Numbers  ICMJE R01HS013603( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anthony Jerant, MD, University of California Davis School of Medicine
Study Sponsor  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony F Jerant, MD University of California, Davis
PRS Account Agency for Healthcare Research and Quality (AHRQ)
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP