Back to resultsA Family Intervention for Improving Self-Care of Patients With Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
psychoeducational
wait list
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure, Congestive focused on measuring heart failure intervention
Eligibility 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.
Sites / Locations
- VA Medical Center, Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
1
2
Arm Description
Control condition is wait-list control.
Active treatment condition: psychoeducational intervention for patients with HF
Outcomes
Primary Outcome Measures
dietary sodium intake
Secondary Outcome Measures
medication adherence
Full Information
NCT ID
NCT00645489
First Posted
March 24, 2008
Last Updated
January 4, 2010
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00645489
Brief Title
A Family Intervention for Improving Self-Care of Patients With Heart Failure
Official Title
A Family Intervention for Improving Self-Care of Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study of a family-based educational program for patients with heart failure, and their 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.
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 intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Control condition is wait-list control.
Arm Title
2
Arm Type
Experimental
Arm Description
Active treatment condition: psychoeducational intervention for patients with HF
Intervention Type
Behavioral
Intervention Name(s)
psychoeducational
Intervention Description
Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members
Intervention Type
Other
Intervention Name(s)
wait list
Intervention Description
Wait list
Primary Outcome Measure Information:
Title
dietary sodium intake
Time Frame
6 months
Secondary Outcome Measure Information:
Title
medication adherence
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L. Sayers, PhD
Organizational Affiliation
VA Medical Center, Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Family Intervention for Improving Self-Care of Patients With Heart Failure
We'll reach out to this number within 24 hrs