A Family Intervention for Improving Self-Care of Patients With Heart Failure - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00645489

Purpose

This is a pilot study of a family-based educational program for patients with heart failure, and their family members.

Condition	Intervention	Phase
Heart Failure, Congestive	Behavioral: psychoeducational Other: wait list	Phase 0

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Family Intervention for Improving Self-Care of Patients With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

dietary sodium intake [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Control condition is wait-list control.	Other: wait list Wait list
2: Experimental Active treatment condition: psychoeducational intervention for patients with HF	Behavioral: psychoeducational Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members

Detailed Description:

Objectives(s): We plan to conduct a feasibility pilot trial of the Family Partnership Intervention (FPI) compared to patients in the HF Wait-list (WL) condition. We plan to demonstrate feasibility, estimate variances of major outcome variables, and to obtain preliminary estimates of effect sizes in preparation for subsequent grant applications. We will be able to develop a cost-effectiveness model for the relative benefit of FPI vs. no family-based for use in longer-term studies.
Research Design: This is a short-term, randomized clinical trial which will involve assessments for participants in the FPI condition at a pre-intervention Baseline point, immediately post-intervention, and 6 months post-intervention. Participants in the WL condition will be assessed at Baseline, undergo an approximately 8 week waiting period, and then the FPI. A longer follow-up is not planned based on the purpose of this study as a feasibility trial.
Methodology: We plan to randomize 40 Veterans and their family members to either the FPI condition or WL condition, in equal proportions. We will recruit patients with at least Stage C Heart Failure (NYHA class I - IV) from the Cardiology clinic of the Philadelphia VAMC. FPI will involve 4-6 hours of intervention delivered over a period of 6-8 weeks. Assessments at a pre-treatment baseline point, 8 weeks (immediately post-treatment), and 6 months will cover the following domains: a) patients' demographic characteristics and clinical functioning, b) self-care, including self-management of symptoms, knowledge of HF, and adherence to medication and dietary intake of sodium, c) measures of family functioning relevant to the medical care of the patient, and d) health care utilization costs. Primary outcome measures will be patients' self-reported HF self-care and health care utilization costs. We anticipate that patients in the FPI condition will exhibit better self-care over time compared to patients in the WL condition. We also anticipate that patients and family members will exhibit an improved family environment and better HF knowledge.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage C Heart Failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. Indicated by chronic systolic dysfunction (left ventricle [LV] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the LV), or both.
The patient's cardiologist has recommended or initiated one of the following to prevent decompensation:

continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake.
A family member or members available for study participation with whom patient lives for at least 5 days a week. Emphasis will be given to the closest family members available (i.e., spouse).
Subjects are able to give informed consent (see below for exclusion due to well-documented dementia or evidence of cognitive impairment).
Patients will be age 50 or above. Younger patients may have a different family environment than the most common type of patient who is the target of the FPI intervention.

Exclusion Criteria:

Patient has a well-documented diagnosis of dementia
Moderate or greater cognitive impairment, based on the Blessed Test of Orientation, Memory, and Concentration (BOMC)[26] score of 16.
Patient's family member has BOMC score of 10 (i.e., mild or greater cognitive impairment).
Inability to communicate verbally, major visual impairment, uncorrected hearing loss.
Patient and/or family member reports "frequent use" illicit substance abuse within the past year.

Scores on the AUDIT-C 4 indicating alcohol abuse/dependence.[30]
Patient or family member has a current diagnosis of schizophrenia spectrum psychiatric disorder (e.g., schizophrenia, schizoaffective disorder).
Patient indicates active suicidal ideation and evaluated as a clinical risk.
Patient is in the Philadelphia VAMC home-telehealth program or some other incompatible intervention.
Patient has an unstable medical condition that would likely prevent the subject from completing the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645489

Contacts

Contact: Jelena C Bubanj

jelena.bubanj@va.gov

Locations

United States, Pennsylvania
VA Medical Center, Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven L Sayers, PhD 215-823-5196 steven.sayers@va.gov
Principal Investigator: Steven L. Sayers, PhD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Steven L. Sayers, PhD

VA Medical Center, Philadelphia

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Sayers, Steven - Principal Investigator )
Study ID Numbers:	MIRECC002, 01008, 0008
Study First Received:	March 24, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00645489 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

heart failure intervention

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009