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

University Hospital, Gentofte, Copenhagen

Status: Unknown

Conditions: Heart Failure NYHA Class II; Chronic Heart Failure; Heart Failure NYHA Class IV; Heart Failure NYHA Class III

Treatments: Other: Early homebased rehabilitation after hospital admission; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01669395

H-2-2012-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Early homebased rehabilitation

Experimental group

Description:

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

Treatment:

Other: Early homebased rehabilitation after hospital admission

control group: Ususal care

Experimental group

Description:

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

Treatment:

Other: Usual care