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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by University Hospital, Gentofte, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Laura Staun Valentiner, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01669395
First received: August 14, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Other: Early homebased rehabilitation after hospital admission
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Readmission due to heart failure [ Time Frame: assessed one year after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical capacity [ Time Frame: Assessed at baseline, after 6 weeks, after 6 month and after one year ] [ Designated as safety issue: No ]
    measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test

  • Activity of Daily Living [ Time Frame: Assessed at baseline, after 6 weeks, after 6 month and after one year ] [ Designated as safety issue: No ]
    Recorded at an ADL interview to assess the performance of everyday activities

  • Number of total hospital admissions [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ] [ Designated as safety issue: No ]
  • Exercise Compliance [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ] [ Designated as safety issue: No ]
    registration of exercise

  • Anxiety and depression [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ] [ Designated as safety issue: No ]
    measured by Hospital Anxiety and Depression Scale (HAD)

  • Quality of life [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ] [ Designated as safety issue: No ]
    measured by The Minnesota Living with Heart Failure Questionnaire

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early homebased rehabilitation
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
Other: Early homebased rehabilitation after hospital admission
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
Other Names:
  • severe heart failure
  • homebased rehabilitation
  • physical exercise
  • activities of daily living
Experimental: control group: Ususal care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
Other: Usual care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01669395

Contacts
Contact: Laura Staun Valentiner, Master in health scien + 45 39 77 39 51 laura.risted.staun.valentiner@regionh.dk
Contact: Carsten Juhl, Ph.D.stud + 45 39 77 39 51 carsten.juhl@regionh.dk

Locations
Denmark
Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte, Not yet recruiting
Copenhagen, Gentofte, Denmark, 2900
Contact: Laura Staun Valentiner, masters in health sciences    + 45 39 77 39 51    laura.risted.staun.valentiner@regionh.dk   
Contact: Carsten Juhl, Ph.D stud.    + 45 39 77 39 51    carsten.juhl@regionh.dk   
Principal Investigator: Laura Staun Valentiner, Masters in Health Science         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
  More Information

No publications provided

Responsible Party: Laura Staun Valentiner, Research and Development Physiotherapist, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01669395     History of Changes
Other Study ID Numbers: H-2-2012-021
Study First Received: August 14, 2012
Last Updated: August 16, 2012
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by University Hospital, Gentofte, Copenhagen:
Severe heart failure
Homebased rehabilitation
Physical exercise
Activities of daily living
Intersectoral Cooperation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014