Diabetes MellitusNCT00263939
Homing in on Health: Study of a Home Delivered Chronic Disease Self Management Program
A study testing Homing in on Health in people with Diabetes Mellitus and Congestive Heart Failure, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Congestive Heart Failure, Arthritis
- What is being tested?
- Homing in on Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Congestive Heart Failure, Arthritis, COPD, Depression
- Being tested
- Homing in on Health
- Keywords
- chronic disease, patient education, self-efficacy, self-management
- Medical subject headings
- Diabetes Mellitus, Heart Failure, Arthritis, Pulmonary Disease, Chronic Obstructive, Depression, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homing in on HealthBehavioural
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 group | Role | What they receive |
|---|---|---|
| 1 - In home intervention | Experimental | In home (face to face) delivery of the study intervention, Homing in on Health Receives: Behavioral: Homing in on Health |
| 2 - Telephone intervention | Experimental | Telephone delivery of the study intervention, Homing in on Health Receives: Behavioral: Homing in on Health |
| 3 - Usual care | No intervention | Patients receiving the care their usual health providers supply, without an study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Investigators
- Anthony F Jerant, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263939
- Sponsor's protocol ID
- R01HS013603
- Status last verified
- Feb 2010
- First submitted
- 9 Dec 2005
- Last updated
- 5 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15893212Jerant 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.
PubMed 18953223Jerant 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.
PubMed 18839336Franks 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.
PubMed 18808733Jerant 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.
PubMed 18796506Jerant 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.
PubMed 18438201Chapman 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.
PubMed 19543121Jerant 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.
PubMed 19273870
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Home Self-Efficacy Enhancement
- ClinicalTrials.gov ID
- NCT00263939
- Acronym / sponsor ID
- R01HS013603
- Conditions
- Diabetes Mellitus, Congestive Heart Failure, Arthritis, COPD, Depression
- Keywords
- chronic disease, patient education, self-efficacy, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Jul 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - In home intervention | Experimental | Behavioral: Homing in on HealthIn home (face to face) delivery of the study intervention, Homing in on Health |
| 2 - Telephone intervention | Experimental | Behavioral: Homing in on HealthTelephone delivery of the study intervention, Homing in on Health |
| 3 - Usual care | No intervention | –Patients receiving the care their usual health providers supply, without an study intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homing in on HealthA 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. | Behavioural | 1 - In home intervention, 2 - Telephone intervention |
Primary outcome
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
1 secondary outcome
self-care self-efficacy at 2wks and 4wks during the intervention, immediately post intervention and at 6 months and 1 year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
- Background: PubMed 15893212Jerant 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.
- Background: PubMed 18953223Jerant 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.
- Background: PubMed 18839336Jerant 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 publication: PubMed 18808733Franks 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 publication: PubMed 18796506Jerant 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 publication: PubMed 18438201Jerant 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.
- Derived from this study: PubMed 19543121Chapman 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.
- Derived from this study: PubMed 19273870Jerant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony F Jerant, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homing in on Health in people with Diabetes Mellitus and Congestive Heart Failure, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263939, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2010.