Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263939
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2005-12-09
Brief Title:
Homing in on Health Study of a Home Delivered Chronic Disease Self Management Program
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
A Randomized Trial of Home Self-Efficacy Enhancement
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 payers 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
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 payers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None