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

Chronic Heart Failure Clinical Trial

Official title:

Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01669395
• Other study ID #: H-2-2012-021
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2012
• Last updated: August 16, 2012
• Start date: September 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2012
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Laura Staun Valentiner, Master in health scien
• Phone: + 45 39 77 39 51
• Email: laura.risted.staun.valentiner[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,	Copenhagen	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission due to heart failure		assessed one year after inclusion	No
Secondary	Physical capacity	measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test	Assessed at baseline, after 6 weeks, after 6 month and after one year	No
Secondary	Activity of Daily Living	Recorded at an ADL interview to assess the performance of everyday activities	Assessed at baseline, after 6 weeks, after 6 month and after one year	No
Secondary	Number of total hospital admissions		at baseline, after 6 weeks, after 6 month and after one year	No
Secondary	Exercise Compliance	registration of exercise	at baseline, after 6 weeks, after 6 month and after one year	No
Secondary	Anxiety and depression	measured by Hospital Anxiety and Depression Scale (HAD)	at baseline, after 6 weeks, after 6 month and after one year	No
Secondary	Quality of life	measured by The Minnesota Living with Heart Failure Questionnaire	at baseline, after 6 weeks, after 6 month and after one year	No
Secondary	Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)		at 6 weeks, after 6 month and after one year	No