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

This study has been completed.
Sponsor:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00263939
First received: December 9, 2005
Last updated: October 4, 2010
Last verified: February 2010

December 9, 2005
October 4, 2010
July 2004
October 2006   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00263939 on ClinicalTrials.gov Archive Site
self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
Same as current
Not Provided
Not Provided
 
Homing in on Health: Study of a Home Delivered Chronic Disease Self Management Program
A Randomized Trial of Home Self-Efficacy Enhancement

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Congestive Heart Failure
  • Arthritis
  • COPD
  • Depression
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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
October 2007
October 2006   (final data collection date for primary outcome measure)

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

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00263939
R01HS13603
Yes
Anthony Jerant, MD, University of California Davis School of Medicine
Agency for Healthcare Research and Quality (AHRQ)
Not Provided
Principal Investigator: Anthony F Jerant, MD University of California, Davis
Agency for Healthcare Research and Quality (AHRQ)
February 2010

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