Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive Voice Response System
Nurse-Led Group Clinic Visits
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure, Congestive focused on measuring Heart Failure, Peer Support, Self Management
Eligibility Criteria
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
Sites / Locations
- St. Joseph Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Behavioral: IVR
Behavioral: Nurse-Led Group Visits
Outcomes
Primary Outcome Measures
Re-hospitalization and death rates
Total hospitalizations
HF-specific quality of life
Secondary Outcome Measures
HF self-management behaviors, treatment regimens, and perceived social support
HF self-care self-efficacy and autonomous motivation
Satisfaction with HF care
Depressive symptoms
Full Information
NCT ID
NCT00508508
First Posted
July 27, 2007
Last Updated
June 17, 2013
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00508508
Brief Title
Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
Official Title
Mobilizing Peer Support for Effective Heart Failure Self-Management
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Heart Failure, Peer Support, Self Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral: IVR
Arm Title
2
Arm Type
Experimental
Arm Description
Behavioral: Nurse-Led Group Visits
Intervention Type
Behavioral
Intervention Name(s)
Interactive Voice Response System
Other Intervention Name(s)
Telephone Peer-Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-Led Group Clinic Visits
Other Intervention Name(s)
Self-Management Group Support and Training
Intervention Description
At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.
Primary Outcome Measure Information:
Title
Re-hospitalization and death rates
Time Frame
Measured at Month 12
Title
Total hospitalizations
Time Frame
Measured at Month 12
Title
HF-specific quality of life
Time Frame
Measured at Months 6 and 12
Secondary Outcome Measure Information:
Title
HF self-management behaviors, treatment regimens, and perceived social support
Time Frame
Measured at Months 6 and 12
Title
HF self-care self-efficacy and autonomous motivation
Time Frame
Measured at Months 6 and 12
Title
Satisfaction with HF care
Time Frame
Measured at Months 6 and 12
Title
Depressive symptoms
Time Frame
Measured at Months 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.E. Michele Heisler, MD
Organizational Affiliation
University of Michigan, Ann Arbor, Internal Medicine, General Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23388114
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
We'll reach out to this number within 24 hrs