NCT00508508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 18, 2013

Status Verified

July 1, 2011

Enrollment Period

3.5 years

First QC Date

July 27, 2007

Last Update Submit

June 17, 2013

Conditions

Heart Failure, Congestive

Keywords

Heart FailurePeer SupportSelf Management

Outcome Measures

Primary Outcomes (3)

  • Re-hospitalization and death rates

    Measured at Month 12

  • Total hospitalizations

    Measured at Month 12

  • HF-specific quality of life

    Measured at Months 6 and 12

Secondary Outcomes (4)

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

    Measured at Months 6 and 12

  • HF self-care self-efficacy and autonomous motivation

    Measured at Months 6 and 12

  • Satisfaction with HF care

    Measured at Months 6 and 12

  • Depressive symptoms

    Measured at Months 6 and 12

Study Arms (2)

1

EXPERIMENTAL

Behavioral: IVR

Behavioral: Interactive Voice Response System

2

EXPERIMENTAL

Behavioral: Nurse-Led Group Visits

Behavioral: Nurse-Led Group Clinic Visits

Interventions

Interactive Voice Response SystemBEHAVIORAL

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
1
Nurse-Led Group Clinic VisitsBEHAVIORAL

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
2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (1)

  • 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.

    PMID: 23388114DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • M.E. Michele Heisler, MD

    University of Michigan, Ann Arbor, Internal Medicine, General Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 30, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 18, 2013

Record last verified: 2011-07

Locations

US(1)