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Early Home-Based Rehabilitation for Severe Heart Failure Patients

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Study Aim

This study aims to evaluate the effectiveness of early home-based rehabilitation in reducing readmission due to heart failure in severe heart failure patients.

What is being tested

Early homebased rehabilitation after hospital admission

+ Usual care

Other
Who is being recruted

Behavior+2

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Gentofte, Copenhagen
Study ContactLaura Staun Valentiner, Master in health scienMore contacts
Last updated: August 21, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01669395
Principal SponsorUniversity Hospital, Gentofte, Copenhagen
Study ContactLaura Staun Valentiner, Master in health scienMore contacts
Last updated: August 21, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorCardiovascular DiseasesHeart DiseasesHeart FailureMotor Activity

Criteria

6 inclusion criteria required to participate
Patients admitted to the Gentofte Hospital due to heart failure
Patients who can speak and understand Danish
Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality
Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status
Show More Criteria
2 exclusion criteria prevent from participating
Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression)
Patients with terminal illness with expected death within a year

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Copenhagen, DenmarkOpen Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte, in Google Maps
SuspendedOne Study Center