Effect of Behavioral Management on Quality of Life in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012870
First received: March 14, 2001
Last updated: October 25, 2013
Last verified: February 2007

March 14, 2001
October 25, 2013
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  • Psychological symptom distress (Multiple Affect Adjective Check List - MAACL)
  • Physical functioning (SF-36 physical component summary score)
  • Mental functioning (SF-36 mental component summary score)
  • Exercise capability (6-Minute Walk)
  • General health perceptions (SF-36 general health scale score)
Complete list of historical versions of study NCT00012870 on ClinicalTrials.gov Archive Site
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Effect of Behavioral Management on Quality of Life in Heart Failure
Effect of Behavioral Management on Quality of Life in Heart Failure

Nurses play an important role in helping patients to manage symptoms, adhere to treatment, and change behavior. There has been a lack of research regarding nonpharmacologic interventions with patients with heart failure and other chronic conditions.

Background:

Nurses play an important role in helping patients to manage symptoms, adhere to treatment, and change behavior. There has been a lack of research regarding nonpharmacologic interventions with patients with heart failure and other chronic conditions.

Objectives:

The primary objective of this 4-year study was to determine the effect of a nurse-led behavioral management intervention on health-related quality in patients with medically-managed heart failure. The secondary objective was to assess the impact of the behavioral management intervention on health care resource utilization.

Methods:

DESIGN: randomized controlled trial. SETTING: single site, VA San Diego Healthcare System. SAMPLE: Patients were enrolled in 11 cohorts a total of 116 outpatients were randomly assigned to one of two treatment groups to evaluate the clinical impact of the intervention. Group 1 received usual care for patients with heart failure (n=58). Group 2 was an augmented group receiving usual care plus participation in the 15-week (4-month) behavioral management program (n=58). Inclusion criteria were that the patient had a primary diagnosis of heart failure, a VA primary care provider, stable symptoms for at least one month and was able to walk. INTERVENTION: The behavioral management program augmented usual care and consisted of establishing specific goals with patients related to healthier diet, increased quality and amount of exercise, smoking cessation, and increased social and interpersonal activities. DEPENDENT VARIABLES/OUTCOME MEASURES: The five major dependent variables for this study were psychological symptom distress (Multiple Affect Adjective Check List - MAACL), physical functioning (SF-36 physical component summary score), mental functioning (SF-36 mental component summary score), exercise capability (6-Minute Walk), and general health perceptions (SF-36 general health scale score). Dependent variables were assessed at baseline, at the end of treatment (at 4 months), and then at 10 and 16 months. DATA ANALYSIS: Initial analyses included all subjects who were randomized to treatment and completed all data collection time points in a series of 2 by 4 ANOVAs with time as a repeated measure.

Status:

Completed. Final report submitted August 2003

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Heart Failure
Behavioral: Behavioral Management
Arm 1
Intervention: Behavioral: Behavioral Management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
March 2002
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Inclusion Criteria:

Inclusion criteria are that the patient has a primary diagnosis of dilated cardiomyopathy or heart failure, a VA primary care provider, stable symptoms for at least one month and is able to walk.

Exclusion Criteria:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012870
NRI 95-244
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Martha J. Shively, PhD RN San Diego Veterans Healthcare System
Department of Veterans Affairs
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP