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CompletedNCT00508508Updated Jun 18, 2013

Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care

An interventional study of Interactive Voice Response System and Nurse-Led Group Clinic Visits in Heart Failure, Congestive, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-06-18.

Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
266
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

Heart failure (HF) patients living in low-income or isolated areas may have limited access to necessary clinic services and more difficulty in self-managing their illness. This study will evaluate a program that combines group health care visits and a peer-to-peer telephone buddy system at improving health outcomes among low-income and racial minority HF patients.

Read the detailed description

HF is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is important for individuals with heart failure to closely monitor their symptoms, seek out medical attention when appropriate, and effectively self-manage their condition. However, people with HF are often frail, poor, and socially isolated. These factors may limit their ability to access clinic-based services and self-manage their condition. Research has shown that group health care visits with other HF patients and peer support for self-care behaviors are effective at improving heath care outcomes. This study will use an interactive voice response (IVR) system, which is a low-cost telephone system that allows calls to be made through a central 1-800 number, thereby eliminating the need to distribute home phone numbers or pay for long distance calls. Through the IVR system, participants will receive and provide peer support by sharing and discussing HF self-management techniques. The IVR system will also facilitate patient communication with care managers. This study will evaluate the effectiveness of the peer-to-peer IVR program in combination with group health care visits led by HF nurses at reducing hospitalization and death rates among HF patients. Participants will be drawn from a community health care system that primarily serves large numbers of racial minority and socioeconomically vulnerable people.

This study will enroll 288 moderate- to high-risk HF patients from St. Joseph Mercy Health System in Ypsilanti, Michigan. Participants will be paired up with another HF patient, based on gender and illness severity. Each pair will be randomly assigned to receive either usual care or usual care plus the nurse-led group visits and the IVR program. Participants using IVR will receive training in peer communication techniques and participate in an initial nurse-led interactive group visit. They will then be asked to communicate at least weekly with their partner using the IVR system. The IVR system will also automatically send reminder calls to participants and allow them to leave voice mail messages for their partner and their care manager. At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies. Study staff will monitor participants' use of the IVR system, including the dates, duration, and recipients of all phone calls. At Months 6 and 12, all participants will complete questionnaires and undergo a medical record review to assess hospitalization and death rates, quality of life, self-management behaviors, social support, satisfaction with HF care, and depression symptoms.

02

Conditions studied

  • Heart Failure, Congestive

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Keywords

  • Heart Failure
  • Peer Support
  • Self Management
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 266 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Diagnosed with HF
  • Inpatient Hospital stay or Heart Failure Clinic Appointment

Exclusion criteria

Exclusion Criteria:

  • Serious mental illness or cognitive dysfunction
  • Does not speak English fluently
  • Receives most HF care outside the St. Joseph Mercy Health System
  • Unable to use the telephone to access the IVR system
  • Will be discharged to a long-term care or hospice facility
  • End-stage cancer or other end-stage condition
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
266 participants (actual)

Study arms

  • Experimental
    1

    Behavioral: IVR

    Behavioral: Interactive Voice Response System

  • Experimental
    2

    Behavioral: Nurse-Led Group Visits

    Behavioral: Nurse-Led Group Clinic Visits

Interventions

  • BehavioralInteractive Voice Response System

    Participants using IVR will receive training in peer communication techniques and participate in an initial nurse-led interactive group visit. They will then be asked to communicate at least weekly with their partner using the IVR system. The IVR system will also automatically send reminder calls to participants and allow them to leave voice mail messages for their partner and their care manager.

    Also known as: Telephone Peer-Support

  • BehavioralNurse-Led Group Clinic Visits

    At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.

    Also known as: Self-Management Group Support and Training

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What researchers measure

Primary outcomes

  1. Re-hospitalization and death rates

    Time frame: Measured at Month 12

  2. Total hospitalizations

    Time frame: Measured at Month 12

  3. HF-specific quality of life

    Time frame: Measured at Months 6 and 12

Secondary outcomes

  1. HF self-management behaviors, treatment regimens, and perceived social support

    Time frame: Measured at Months 6 and 12

  2. HF self-care self-efficacy and autonomous motivation

    Time frame: Measured at Months 6 and 12

  3. Satisfaction with HF care

    Time frame: Measured at Months 6 and 12

  4. Depressive symptoms

    Time frame: Measured at Months 6 and 12

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Study locations

1 site
  • St. Joseph Mercy Hospital
    Ypsilanti, Michigan 48197, United States
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References and documents

Publications

  • Heisler M, Halasyamani L, Cowen ME, Davis MD, Resnicow K, Strawderman RL, Choi H, Mase R, Piette JD. Randomized controlled effectiveness trial of reciprocal peer support in heart failure. Circ Heart Fail. 2013 Mar;6(2):246-53. doi: 10.1161/CIRCHEARTFAILURE.112.000147. Epub 2013 Feb 6. PubMed 23388114 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 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
NCT00508508
Lead sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Rebecca Mase (Project Manager, University of Michigan) — Principal investigator
First posted
Jul 30, 2007
Start date
Apr 2007
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Jun 18, 2013

Study contacts

M.E. Michele Heisler, MD
principal investigator · University of Michigan, Ann Arbor, Internal Medicine, General Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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