Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Thomas Kahan, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01671995
First received: August 19, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Heart Failure
Procedure: Nurse monitored heart failure program
Procedure: Standard primary health care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Nottingham health profile used for quality of life assessment


Secondary Outcome Measures:
  • Hospitalizations [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Registry data that cover all hospitalizations for all patients

  • Evaluation of heart failure medication [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication

  • Mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Mortality from death certificates obtained.


Enrollment: 208
Study Start Date: January 1996
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: Nurse monitored heart failure program
Standard program for a heart failure clinic with information, education, drug titration
Active Comparator: 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.
Procedure: Standard primary health care
Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671995

Locations
Sweden
Danderyd University Hospital Corp
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Study Chair: Magnus Edner, MD, PhD Karolinska Institutet
  More Information

Publications:
Responsible Party: Thomas Kahan, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01671995     History of Changes
Other Study ID Numbers: OPTIMAL
Study First Received: August 19, 2012
Last Updated: August 21, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Heart failure
Quality of life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014