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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rebecca Mase, University of Michigan
ClinicalTrials.gov Identifier:
NCT00508508
First received: July 27, 2007
Last updated: June 17, 2013
Last verified: July 2011

July 27, 2007
June 17, 2013
April 2007
October 2010   (final data collection date for primary outcome measure)
  • Re-hospitalization and death rates [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Total hospitalizations [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • HF-specific quality of life [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Re-hospitalization and death rates [ Time Frame: Measured at Month 12 ]
  • Total hospitalizations [ Time Frame: Measured at Month 12 ]
  • HF-specific quality of life [ Time Frame: Measured at Months 6 and 12 ]
Complete list of historical versions of study NCT00508508 on ClinicalTrials.gov Archive Site
  • HF self-management behaviors, treatment regimens, and perceived social support [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • HF self-care self-efficacy and autonomous motivation [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Satisfaction with HF care [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • HF self-management behaviors, treatment regimens, and perceived social support [ Time Frame: Measured at Months 6 and 12 ]
  • HF self-care self-efficacy and autonomous motivation [ Time Frame: Measured at Months 6 and 12 ]
  • Satisfaction with HF care [ Time Frame: Measured at Months 6 and 12 ]
  • Depressive symptoms [ Time Frame: Measured at Months 6 and 12 ]
Not Provided
Not Provided
 
Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Heart Failure, Congestive
  • Behavioral: Interactive 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.
    Other Name: Telephone Peer-Support
  • Behavioral: Nurse-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.
    Other Name: Self-Management Group Support and Training
  • Experimental: 1
    Behavioral: IVR
    Intervention: Behavioral: Interactive Voice Response System
  • Experimental: 2
    Behavioral: Nurse-Led Group Visits
    Intervention: Behavioral: Nurse-Led Group Clinic Visits
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 1;6(2):246-53. doi: 10.1161/CIRCHEARTFAILURE.112.000147. Epub 2013 Feb 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00508508
429, 1R01HL085420-01, 1 R01 HL085420-01
Yes
Rebecca Mase, University of Michigan
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: M.E. Michele Heisler, MD University of Michigan, Ann Arbor, Internal Medicine, General Medicine
University of Michigan
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP