Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

Karolinska Institute

Status: Completed

Conditions: Heart Failure

Treatments: Procedure: Standard primary health care; Procedure: Nurse monitored heart failure program

Study type: Interventional

Funder types: Other

Identifiers

NCT01671995

OPTIMAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Nurse monitored heart failure program

Experimental group

Description:

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.

Treatment:

Procedure: Nurse monitored heart failure program

Standard primary health care

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard primary health care