Heart FailureNCT01071967
Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
A study testing Community-based nurse care management in people with Heart Failure and Coronary Disease, run by Health Quality Partners at 1 site in United States.
Trial summary
Care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Coronary Disease, Diabetes Mellitus
- What is being tested?
- Community-based nurse care management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Dec 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years and older
- Medicare Part A and B traditional, fee for service insurance coverage
- One or more of the following chronic conditions:
- Heart failure
- Coronary Disease
- Diabetes mellitus
Show all 12Show fewer
- Asthma
- Hypertension
- Hypercholesterolemia
- A Geriatric Risk Stratification Level of 2 or more based on a pre-enrollment screening tool
- Geriatric Risk Stratification Level changed in Sep 2006 to a Level of 3 or more
- Willingness of the participant's primary care provider to collaborate
Who cannot join
- Amyotrophic lateral sclerosis
- Alzheimer's disease
- Dementia
- Diagnosis or history of cancer (other than skin) in the past 5 years
- End-stage renal disease
- Life expectancy on enrollment less than 6 months
Show all 13Show fewer
- HIV or AIDS
- Huntington's disease
- Organ transplant candidate
- Psychosis or schizophrenia
- Resident of or imminent plan for long-term nursing home placement
- Seasonal relocation outside of the area for more than 4 weeks per year
- Anyone receiving service from Health Quality Partners in the past
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Quality Partners
Doylestown, Pennsylvania, 18902
About this study
Official title: Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. This study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population. The results reflect the impact of one of the study sites (Health Quality Partners) selected by the Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated Care Demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults. The study began in April 2002.
Read the detailed description
The community-based nursing care management model developed by Health Quality Partners represents a comprehensive set of integrated preventive and monitoring services designed for older adults living with chronic diseases. The individual programs and services integrated within the model were selected on the basis of previously demonstrated evidence of effectiveness. The model is delivered in the communities in which participants reside. Care is delivered through in person contacts, (1 to 1 and group) as well as by telephone. In person contacts occur in the home, in readily accessible community and faith-based organizations, health facilities, or the offices of Health Quality Partners. Efforts are made to contact participants in the intervention group at least monthly with care continued until death, voluntary disenrollment, mandatory disenrollment due to changes in insurance coverage, relocation out of the service area, or change in long term level of care (e.g., nursing home placement, hospice).
- Conditions
- Heart Failure, Coronary Disease, Diabetes Mellitus, Asthma, Hypertension, Hypercholesterolemia
- Being tested
- Community-based nurse care management
- Keywords
- Community Health Nursing, Nursing Care Management, Aged, Aged, 80 and over, Health Services for the Aged, Geriatric Nursing, Geriatric Assessment, Longevity, Mortality
- Medical subject headings
- Heart Failure, Coronary Disease, Diabetes Mellitus, Asthma, Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based nurse care managementOther
Also called Health Quality Partners, Medicare Coordinated Care Demonstration, Care Coordination, Disease Management
The community-based nurse care management program developed by Health Quality Partners uses nurses working in the community to provide the following integrated set of services to older adults with chronic illness over the long term in order to prevent avoidable complications of their diseases and aging; geriatric assessment, care coordination, health education, self-management coaching, weight management, physical activity, gait and balance training, medication adherence, care transition support, ongoing monitoring and symptom detection, collaborative problem solving with patients, families and health care providers.
| Study group | Role | What they receive |
|---|---|---|
| Community-based nurse care management | Experimental | Participants randomized to receive the intervention worked with a nurse care manager who provided them with a comprehensive set of geriatric and chronic disease preventive services. Receives: Other: Community-based nurse care management |
| Usual care | No intervention | Participants randomized to the control group received usual care without the involvement of a nurse care manager. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: within 5 years of enrollment
Secondary outcomes (5)
Blood pressure control
Measured: within 5 years of enrollment
Total cholesterol control
Measured: within 5 years of enrollment
Low density cholesterol control
Measured: within 5 years of enrollment
Triglycerides control
Measured: within 5 years of enrollment
Weight control
Measured: within 5 years of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startApr 2002
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Quality Partners
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Kenneth D Coburn, MD, MPH, Principal investigator, Health Quality Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071967
- Sponsor's protocol ID
- 95-C-91360/3-01
- Status last verified
- Sep 2013
- First submitted
- 16 Dec 2009
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.
PubMed 19211468Brown R, Peikes D, Chen A, Schore J. 15-site randomized trial of coordinated care in Medicare FFS. Health Care Financ Rev. 2008 Fall;30(1):5-25.
PubMed 19040171Bott DM, Kapp MC, Johnson LB, Magno LM. Disease management for chronically ill beneficiaries in traditional Medicare. Health Aff (Millwood). 2009 Jan-Feb;28(1):86-98. doi: 10.1377/hlthaff.28.1.86.
PubMed 19124858Coburn KD, Marcantonio S, Lazansky R, Keller M, Davis N. Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial. PLoS Med. 2012;9(7):e1001265. doi: 10.1371/journal.pmed.1001265. Epub 2012 Jul 17.
PubMed 22815653
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
- ClinicalTrials.gov ID
- NCT01071967
- Acronym / sponsor ID
- 95-C-91360/3-01
- Conditions
- Heart Failure, Coronary Disease, Diabetes Mellitus, Asthma, Hypertension, Hypercholesterolemia
- Keywords
- Community Health Nursing, Nursing Care Management, Aged, Aged, 80 and over, Health Services for the Aged, Geriatric Nursing, Geriatric Assessment, Longevity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Health Quality PartnersUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Apr 2002
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Feb 2010 (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.
Care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. This study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population. The results reflect the impact of one of the study sites (Health Quality Partners) selected by the Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated Care Demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults. The study began in April 2002.
Detailed description
The community-based nursing care management model developed by Health Quality Partners represents a comprehensive set of integrated preventive and monitoring services designed for older adults living with chronic diseases. The individual programs and services integrated within the model were selected on the basis of previously demonstrated evidence of effectiveness. The model is delivered in the communities in which participants reside. Care is delivered through in person contacts, (1 to 1 and group) as well as by telephone. In person contacts occur in the home, in readily accessible community and faith-based organizations, health facilities, or the offices of Health Quality Partners. Efforts are made to contact participants in the intervention group at least monthly with care continued until death, voluntary disenrollment, mandatory disenrollment due to changes in insurance coverage, relocation out of the service area, or change in long term level of care (e.g., nursing home placement, hospice).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-based nurse care management | Experimental | Other: Community-based nurse care managementParticipants randomized to receive the intervention worked with a nurse care manager who provided them with a comprehensive set of geriatric and chronic disease preventive services. |
| Usual care | No intervention | –Participants randomized to the control group received usual care without the involvement of a nurse care manager. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Aged 65 years and older
- Medicare Part A and B traditional, fee for service insurance coverage
- One or more of the following chronic conditions:
- Heart failure
- Coronary Disease
Key exclusion criteria (13 listed)
- Amyotrophic lateral sclerosis
- Alzheimer's disease
- Dementia
- Diagnosis or history of cancer (other than skin) in the past 5 years
- End-stage renal disease
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 |
|---|---|---|
| Community-based nurse care managementAlso: Health Quality Partners, Medicare Coordinated Care Demonstration, Care Coordination, Disease ManagementThe community-based nurse care management program developed by Health Quality Partners uses nurses working in the community to provide the following integrated set of services to older adults with chronic illness over the long term in order to prevent avoidable complications of their diseases and aging; geriatric assessment, care coordination, health education, self-management coaching, weight management, physical activity, gait and balance training, medication adherence, care transition support, ongoing monitoring and symptom detection, collaborative problem solving with patients, families and health care providers. | Other | Community-based nurse care management |
Primary outcome
All-cause mortality
Time frame: within 5 years of enrollment
5 secondary outcomes
Blood pressure control
Time frame: within 5 years of enrollment
Total cholesterol control
Time frame: within 5 years of enrollment
Low density cholesterol control
Time frame: within 5 years of enrollment
Triglycerides control
Time frame: within 5 years of enrollment
Weight control
Time frame: within 5 years of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Background: PubMed 19211468Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.
- Background: PubMed 19040171Brown R, Peikes D, Chen A, Schore J. 15-site randomized trial of coordinated care in Medicare FFS. Health Care Financ Rev. 2008 Fall;30(1):5-25.
- Background: PubMed 19124858Bott DM, Kapp MC, Johnson LB, Magno LM. Disease management for chronically ill beneficiaries in traditional Medicare. Health Aff (Millwood). 2009 Jan-Feb;28(1):86-98. doi: 10.1377/hlthaff.28.1.86.
- Derived from this study: PubMed 22815653Coburn KD, Marcantonio S, Lazansky R, Keller M, Davis N. Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial. PLoS Med. 2012;9(7):e1001265. doi: 10.1371/journal.pmed.1001265. Epub 2012 Jul 17.
- Health Quality PartnersLink provided by the sponsor.
- Related ClinicalTrials.gov studyLink provided by the sponsor.
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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.
Kenneth D Coburn, MD, MPH principal investigator
Health Quality Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based nurse care management in people with Heart Failure and Coronary Disease, run by Health Quality Partners 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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Sep 2013. 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?
Results are not available in the source record.
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?
All-cause mortality (time frame: within 5 years of enrollment). 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 NCT01071967, which also lists 4 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 10 Sep 2013.