Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nurse monitored heart failure program
Standard primary health care
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Quality of life
Eligibility 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.
Sites / Locations
- Danderyd University Hospital Corp
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nurse monitored heart failure program
Standard primary health care
Arm 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.
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.
Outcomes
Primary Outcome Measures
Quality of life
Nottingham health profile used for quality of life assessment
Secondary Outcome Measures
Hospitalizations
Registry data that cover all hospitalizations for all patients
Evaluation of heart failure medication
Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication
Mortality
Mortality from death certificates obtained.
Full Information
NCT ID
NCT01671995
First Posted
August 19, 2012
Last Updated
August 21, 2012
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT01671995
Brief Title
Optimising Congestive Heart Failure Outpatient Clinic Project
Acronym
OPTIMAL
Official Title
Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse monitored heart failure program
Arm Type
Experimental
Arm 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.
Arm Title
Standard primary health care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Nurse monitored heart failure program
Intervention Description
Standard program for a heart failure clinic with information, education, drug titration
Intervention Type
Procedure
Intervention Name(s)
Standard primary health care
Intervention Description
Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver
Primary Outcome Measure Information:
Title
Quality of life
Description
Nottingham health profile used for quality of life assessment
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Hospitalizations
Description
Registry data that cover all hospitalizations for all patients
Time Frame
18 months
Title
Evaluation of heart failure medication
Description
Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication
Time Frame
18 months
Title
Mortality
Description
Mortality from death certificates obtained.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Edner, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Danderyd University Hospital Corp
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15310688
Citation
Mejhert M, Kahan T, Persson H, Edner M. Limited long term effects of a management programme for heart failure. Heart. 2004 Sep;90(9):1010-5. doi: 10.1136/hrt.2003.014407.
Results Reference
result
PubMed Identifier
12181213
Citation
Mejhert M, Linder-Klingsell E, Edner M, Kahan T, Persson H. Ventilatory variables are strong prognostic markers in elderly patients with heart failure. Heart. 2002 Sep;88(3):239-43. doi: 10.1136/heart.88.3.239.
Results Reference
result
PubMed Identifier
16213040
Citation
Mejhert M, Kahan T, Persson H, Edner M. Predicting readmissions and cardiovascular events in heart failure patients. Int J Cardiol. 2006 Apr 28;109(1):108-13. doi: 10.1016/j.ijcard.2005.07.015. Epub 2005 Oct 5.
Results Reference
result
PubMed Identifier
18338962
Citation
Mejhert M, Kahan T, Edner M, Persson HE. Sex differences in systolic heart failure in the elderly: the prognostic importance of left ventricular mass in women. J Womens Health (Larchmt). 2008 Apr;17(3):373-81. doi: 10.1089/jwh.2007.0487.
Results Reference
result
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Optimising Congestive Heart Failure Outpatient Clinic Project
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