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Home > "E" Clinical Trials Conditions > Effect of Behavioral Management on Quality of Life in Heart Failure  Effect of Behavioral Management on Quality of Life in Heart Failure
Effect of Behavioral Management on Quality of Life in Heart Failure
For Condition: Heart Failure, Congestive,Cardiomyopathy, Dilated
Status: Completed
Sponsor(s): Department of Veterans Affairs ,
Synopsis: 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. 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. 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.
Details:
Eligibility:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 116
Location and Contact Information:
VA San Diego Health Care Center
San Diego, California, 92161
United States
Additional Information:
Study ID Numbers: NRI 95-244;
Study Start Date: April 1998
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012870
Other Cardiomyopathy, Dilated Studies:
1. Effect of Behavioral Management on Quality of Life in Heart Failure
Related Studies:
Other Cardiomyopathy, Dilated Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Effect of Behavioral Management on Quality of Life in Heart Failure
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