CClinicalTrials.gg
Status unknownNCT01071967Updated Sep 10, 2013

Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults

An interventional study of Community-based nurse care management in Heart Failure, Coronary Disease and Diabetes Mellitus, sponsored by Health Quality Partners. Status unknown at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-09-10.

Sponsored by Health Quality Partners · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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. 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).

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Conditions studied

  • 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
  • Mortality
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In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 124 across 1,583 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

This is the only study on the registry with Health Quality Partners as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Community-based nurse care management

    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.

    Other: Community-based nurse care management

  • No intervention
    Usual care

    Participants randomized to the control group received usual care without the involvement of a nurse care manager.

Interventions

  • OtherCommunity-based nurse care 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.

    Also known as: Health Quality Partners, Medicare Coordinated Care Demonstration, Care Coordination, Disease Management

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What researchers measure

Primary outcomes

  1. All-cause mortality

    Time frame: within 5 years of enrollment

Secondary outcomes

  1. Blood pressure control

    Time frame: within 5 years of enrollment

  2. Total cholesterol control

    Time frame: within 5 years of enrollment

  3. Low density cholesterol control

    Time frame: within 5 years of enrollment

  4. Triglycerides control

    Time frame: within 5 years of enrollment

  5. Weight control

    Time frame: within 5 years of enrollment

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Study locations

1 site
  • Health Quality Partners
    Doylestown, Pennsylvania 18902, United States
08

References and documents

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 19211468 ↗
  • Brown 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 19040171 ↗
  • Bott 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 19124858 ↗
  • Coburn 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01071967
Lead sponsor
Health Quality Partners
Collaborators
Centers for Medicare and Medicaid Services
Responsible party
Sponsor
First posted
Feb 19, 2010
Start date
Apr 2002
Primary completion
Dec 2014 (estimated)
Completion
Dec 2016 (estimated)
Last update
Sep 10, 2013

Study contacts

Kenneth D Coburn, MD, MPH
principal investigator · Health Quality Partners

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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