Clinical trial NCT00012870: Effect of Behavioral Management on Quality of Life in Heart Failure
Official title: Effect of Behavioral Management on Quality of Life in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Martha J. Shively, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shively M, Kodiath M, Smith TL, Kelly A, Bone P, Fetterly L, Gardetto N, Shabetai R, Bozzette S, Dracup K. Effect of behavioral management on quality of life in mild heart failure: a randomized controlled trial. Patient Educ Couns. 2005 Jul;58(1):27-34. doi: 10.1016/j.pec.2004.06.007.
citation: Shively M, Fox C, Brass-Mynderse NJ. Health-related quality of life as an outcome for patients with heart failure. J Cardiovasc Nurs. 1996 Jan;10(2):89-96. doi: 10.1097/00005082-199601000-00009.
citation: Kodiath M, Kelly A, Shively M. Improving quality of life in patients with heart failure: an innovative behavioral intervention. J Cardiovasc Nurs. 2005 Jan-Feb;20(1):43-8. doi: 10.1097/00005082-200501000-00009.