Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012870
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Effect of Behavioral Management on Quality of Life in Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Behavioral Management on Quality of Life in Heart Failure
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n58 Group 2 was an augmented group receiving usual care plus participation in the 15-week 4-month behavioral management program n58 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 VARIABLESOUTCOME 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
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 n58 Group 2 was an augmented group receiving usual care plus participation in the 15-week 4-month behavioral management program n58 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 VARIABLESOUTCOME 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None