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Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671995
First Posted: August 24, 2012
Last Update Posted: August 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Thomas Kahan, Karolinska Institutet
  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
Intervention Model: Parallel Assignment
Masking: None (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 Thomas Kahan, Karolinska Institutet:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 18 months ]
    Nottingham health profile used for quality of life assessment


Secondary Outcome Measures:
  • Hospitalizations [ Time Frame: 18 months ]
    Registry data that cover all hospitalizations for all patients

  • Evaluation of heart failure medication [ Time Frame: 18 months ]
    Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication

  • Mortality [ Time Frame: 18 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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