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Heart Failure, CongestiveNCT00508508

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

A study testing Interactive Voice Response System and Nurse-Led Group Clinic Visits in people with Heart Failure, Congestive, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Interactive Voice Response System and Nurse-Led Group Clinic Visits
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteUnited States
Study dates
Apr 2007to Oct 2010
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: Mobilizing Peer Support for Effective Heart Failure Self-Management

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.

Being tested
Interactive Voice Response System, Nurse-Led Group Clinic Visits
Keywords
Heart Failure, Peer Support, Self Management
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive Voice Response SystemBehavioural

    Also called Telephone Peer-Support

    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.

  • Nurse-Led Group Clinic VisitsBehavioural

    Also called Self-Management Group Support and Training

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

Study groups in NCT00508508
Study groupRoleWhat they receive
1ExperimentalBehavioral: IVR
Receives: Behavioral: Interactive Voice Response System
2ExperimentalBehavioral: Nurse-Led Group Visits
Receives: Behavioral: Nurse-Led Group Clinic Visits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Re-hospitalization and death rates

    Measured: Measured at Month 12

  2. Total hospitalizations

    Measured: Measured at Month 12

  3. HF-specific quality of life

    Measured: Measured at Months 6 and 12

Secondary outcomes (4)
  1. HF self-management behaviors, treatment regimens, and perceived social support

    Measured: Measured at Months 6 and 12

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

    Measured: Measured at Months 6 and 12

  3. Satisfaction with HF care

    Measured: Measured at Months 6 and 12

  4. Depressive symptoms

    Measured: Measured at Months 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00508508
Sponsor's protocol ID
429
Other IDs
1R01HL085420-01
Status last verified
Jul 2011
First submitted
27 Jul 2007
Last updated
18 Jun 2013
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Interactive Voice Response System and Nurse-Led Group Clinic Visits in people with Heart Failure, Congestive, run by University of Michigan 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 2 inclusion and 6 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 18 Jun 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?

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?

Re-hospitalization and death rates (time frame: Measured at Month 12). The study lists 3 primary outcomes in all. 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 NCT00508508, which also lists 1 linked publication.

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 18 Jun 2013.

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