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

Primary Purpose

Diabetes Mellitus, Congestive Heart Failure, Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Homing in on Health
Sponsored by
Agency for Healthcare Research and Quality (AHRQ)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring chronic disease, patient education, self-efficacy, self-management

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1 - In home intervention

2 - Telephone intervention

3 - Usual care

Arm Description

In home (face to face) delivery of the study intervention, Homing in on Health

Telephone delivery of the study intervention, Homing in on Health

Patients receiving the care their usual health providers supply, without an study intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention

Full Information

First Posted
December 9, 2005
Last Updated
October 4, 2010
Sponsor
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00263939
Brief Title
Homing in on Health: Study of a Home Delivered Chronic Disease Self Management Program
Official Title
A Randomized Trial of Home Self-Efficacy Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Congestive Heart Failure, Arthritis, COPD, Depression
Keywords
chronic disease, patient education, self-efficacy, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - In home intervention
Arm Type
Experimental
Arm Description
In home (face to face) delivery of the study intervention, Homing in on Health
Arm Title
2 - Telephone intervention
Arm Type
Experimental
Arm Description
Telephone delivery of the study intervention, Homing in on Health
Arm Title
3 - Usual care
Arm Type
No Intervention
Arm Description
Patients receiving the care their usual health providers supply, without an study intervention
Intervention Type
Behavioral
Intervention Name(s)
Homing in on Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony F Jerant, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15893212
Citation
Jerant AF, von Friederichs-Fitzwater MM, Moore M. Patients' perceived barriers to active self-management of chronic conditions. Patient Educ Couns. 2005 Jun;57(3):300-7. doi: 10.1016/j.pec.2004.08.004.
Results Reference
background
PubMed Identifier
18953223
Citation
Jerant A, DiMatteo R, Arnsten J, Moore-Hill M, Franks P. Self-report adherence measures in chronic illness: retest reliability and predictive validity. Med Care. 2008 Nov;46(11):1134-9. doi: 10.1097/MLR.0b013e31817924e4.
Results Reference
background
PubMed Identifier
18839336
Citation
Jerant A, Chapman BP, Franks P. Personality and EQ-5D scores among individuals with chronic conditions. Qual Life Res. 2008 Nov;17(9):1195-204. doi: 10.1007/s11136-008-9401-y. Epub 2008 Oct 7.
Results Reference
background
PubMed Identifier
18808733
Citation
Franks P, Chapman B, Duberstein P, Jerant A. Five factor model personality factors moderated the effects of an intervention to enhance chronic disease management self-efficacy. Br J Health Psychol. 2009 Sep;14(Pt 3):473-87. doi: 10.1348/135910708X360700. Epub 2008 Sep 20.
Results Reference
result
PubMed Identifier
18796506
Citation
Jerant A, Moore M, Lorig K, Franks P. Perceived control moderated the self-efficacy-enhancing effects of a chronic illness self-management intervention. Chronic Illn. 2008 Sep;4(3):173-82. doi: 10.1177/1742395308089057.
Results Reference
result
PubMed Identifier
18438201
Citation
Jerant A, Kravitz R, Moore-Hill M, Franks P. Depressive symptoms moderated the effect of chronic illness self-management training on self-efficacy. Med Care. 2008 May;46(5):523-31. doi: 10.1097/MLR.0b013e31815f53a4.
Results Reference
result
PubMed Identifier
19543121
Citation
Chapman BP, Franks P, Duberstein PR, Jerant A. Differences between individual and societal health state valuations: any link with personality? Med Care. 2009 Aug;47(8):902-7. doi: 10.1097/MLR.0b013e3181a8112e.
Results Reference
derived
PubMed Identifier
19273870
Citation
Jerant A, Chapman BP, Duberstein P, Franks P. Is personality a key predictor of missing study data? An analysis from a randomized controlled trial. Ann Fam Med. 2009 Mar-Apr;7(2):148-56. doi: 10.1370/afm.920.
Results Reference
derived

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

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