Optimising Congestive Heart Failure Outpatient Clinic Project

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Nurse monitored heart failure program; Procedure: Standard primary health care

• Registration Number: NCT01671995
• Lead Sponsor: Karolinska Institutet

Brief Summary

This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.

Detailed Description

Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.

Study Timeline

• Study Start: 1996-01
• Primary Completion: 2001-06
• Study Completion: 2001-06
• Status Verified: 2012-08
• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Study First Posted: 2012-08-24
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Patients 60 years of age or older
• Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV
• Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography

Exclusion Criteria

• An acute myocardial infarction or unstable angina pectoris within the last three months
• Valvular stenosis
• Dementia
• Severe concomitant disease
• Refusal to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse monitored heart failure program	Nurse monitored heart failure program	To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.
Standard primary health care	Standard primary health care	To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.

Primary Outcome Measures

Name	Time	Method
Quality of life	18 months	Nottingham health profile used for quality of life assessment

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	18 months	Registry data that cover all hospitalizations for all patients
Evaluation of heart failure medication	18 months	Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication
Mortality	18 months	Mortality from death certificates obtained.

Trial Locations

Locations (1)

Danderyd University Hospital Corp; 🇸🇪 Stockholm, Sweden