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Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial

Primary Purpose

Chronic Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Early homebased rehabilitation after hospital admission
Usual care
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Severe heart failure, Homebased rehabilitation, Physical exercise, Activities of daily living, Intersectoral Cooperation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to the Gentofte Hospital due to heart failure.
  • Patients with a functional equivalent to NYHA grade III or IV
  • Patients with ejection fraction <40%
  • Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status
  • Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality.
  • Patients who can speak and understand Danish

Exclusion Criteria:

  • Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
  • Patients with terminal illness with expected death within a year.

Sites / Locations

  • Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early homebased rehabilitation

control group: Ususal care

Arm Description

After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.

After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support

Outcomes

Primary Outcome Measures

Readmission due to heart failure

Secondary Outcome Measures

Physical capacity
measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test
Activity of Daily Living
Recorded at an ADL interview to assess the performance of everyday activities
Number of total hospital admissions
Exercise Compliance
registration of exercise
Anxiety and depression
measured by Hospital Anxiety and Depression Scale (HAD)
Quality of life
measured by The Minnesota Living with Heart Failure Questionnaire
Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)

Full Information

First Posted
August 14, 2012
Last Updated
August 16, 2012
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01669395
Brief Title
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
Official Title
Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of an early, coordinated rehabilitation intervention for patients with severe heart failure in NYHA class III and IV with a ejection fraction of <40% of normal cardiac function measured on frequency of readmissions, physical ability and participation in activities of daily living and quality of life.
Detailed Description
Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for patients quality of life. Patients with severe heart disease often struggle with everyday life, characterized by reduced physical capacity, tendency to depression and anxiety to perform everyday activities that may provoke symptoms. A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large group of patients with severe heart failure and classified in NYHA Class III and IV, deselect the offer because of lack of energy to participate in cardiac rehabilitation or is when specified by a medical assessment discharged from the hospital without the offer of training or any other form of rehabilitation. The offer of rehabilitation for patients with severe heart failure is lacking as it is today. This study assesses the effectiveness of an early home based rehabilitation program that complements the general psycho-social support, symptom-oriented and preventive medical treatment that these patients always have the option to get.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Keywords
Severe heart failure, Homebased rehabilitation, Physical exercise, Activities of daily living, Intersectoral Cooperation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early homebased rehabilitation
Arm Type
Experimental
Arm Description
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
Arm Title
control group: Ususal care
Arm Type
Experimental
Arm Description
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
Intervention Type
Other
Intervention Name(s)
Early homebased rehabilitation after hospital admission
Other Intervention Name(s)
severe heart failure, homebased rehabilitation, physical exercise, activities of daily living
Intervention Description
Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks. From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbæk municipality). Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes. The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home. A training program will be provided and the patient will be instructed to do the exercises every day
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
Primary Outcome Measure Information:
Title
Readmission due to heart failure
Time Frame
assessed one year after inclusion
Secondary Outcome Measure Information:
Title
Physical capacity
Description
measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test
Time Frame
Assessed at baseline, after 6 weeks, after 6 month and after one year
Title
Activity of Daily Living
Description
Recorded at an ADL interview to assess the performance of everyday activities
Time Frame
Assessed at baseline, after 6 weeks, after 6 month and after one year
Title
Number of total hospital admissions
Time Frame
at baseline, after 6 weeks, after 6 month and after one year
Title
Exercise Compliance
Description
registration of exercise
Time Frame
at baseline, after 6 weeks, after 6 month and after one year
Title
Anxiety and depression
Description
measured by Hospital Anxiety and Depression Scale (HAD)
Time Frame
at baseline, after 6 weeks, after 6 month and after one year
Title
Quality of life
Description
measured by The Minnesota Living with Heart Failure Questionnaire
Time Frame
at baseline, after 6 weeks, after 6 month and after one year
Title
Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
Time Frame
at 6 weeks, after 6 month and after one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to the Gentofte Hospital due to heart failure. Patients with a functional equivalent to NYHA grade III or IV Patients with ejection fraction <40% Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality. Patients who can speak and understand Danish Exclusion Criteria: Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression). Patients with terminal illness with expected death within a year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Staun Valentiner, Master in health scien
Phone
+ 45 39 77 39 51
Email
laura.risted.staun.valentiner@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten Juhl, Ph.D.stud
Phone
+ 45 39 77 39 51
Email
carsten.juhl@regionh.dk
Facility Information:
Facility Name
Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
City
Copenhagen
State/Province
Gentofte
ZIP/Postal Code
2900
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Staun Valentiner, masters in health sciences
Phone
+ 45 39 77 39 51
Email
laura.risted.staun.valentiner@regionh.dk
First Name & Middle Initial & Last Name & Degree
Carsten Juhl, Ph.D stud.
Phone
+ 45 39 77 39 51
Email
carsten.juhl@regionh.dk
First Name & Middle Initial & Last Name & Degree
Laura Staun Valentiner, Masters in Health Science

12. IPD Sharing Statement

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Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial

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