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

NCT00645489 | Completed Early Phase 1

• 3 other identifiers: MIRECC002010080008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure, Congestive

Keywords

heart failure intervention

Outcome Measures

Primary Outcomes (1)

• dietary sodium intake

  6 months

Secondary Outcomes (1)

• medication adherence

  6 months

Study Arms (2)

1

OTHER

Control condition is wait-list control.

Other: wait list

2

EXPERIMENTAL

Active treatment condition: psychoeducational intervention for patients with HF

Behavioral: psychoeducational

Interventions

psychoeducational BEHAVIORAL

Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members

2

wait list OTHER

Wait list

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Steven L. Sayers, PhD

  VA Medical Center, Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 6, 2010

Record last verified: 2008-12

Locations

US (1)