Chronic Heart FailureNCT01669395
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
A study testing Early homebased rehabilitation after hospital admission in people with Chronic Heart Failure and Heart Failure NYHA Class II, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- Early homebased rehabilitation after hospital admission
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
- Patients with terminal illness with expected death within a year.
Trial locations and contacts
1 site in 1 country.
Laura Staun Valentiner, Master in health scien contact
Denmark1 site
Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
Copenhagen, Gentofte, 2900
Laura Staun Valentiner, masters in health sciences, + 45 39 77 39 51, laura.risted.staun.valentiner@regionh.dk
Carsten Juhl, Ph.D stud., + 45 39 77 39 51, carsten.juhl@regionh.dk
About this study
Official title: Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Being tested
- Early homebased rehabilitation after hospital admission, Usual care
- Keywords
- Severe heart failure, Homebased rehabilitation, Physical exercise, Activities of daily living, Intersectoral Cooperation
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early homebased rehabilitation after hospital admissionOther
Also called severe heart failure, homebased rehabilitation, physical exercise, activities of daily living
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 careOther
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
| Study group | Role | What they receive |
|---|---|---|
| Early homebased rehabilitation | Experimental | After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks. Receives: Other: Early homebased rehabilitation after hospital admission |
| control group: Ususal care | Experimental | After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission due to heart failure
Measured: assessed one year after inclusion
Secondary outcomes (7)
Physical capacity
measured by the Morton Mobility Index, Timed Up \& Go and Modified Sit to Stand Test
Measured: Assessed at baseline, after 6 weeks, after 6 month and after one year
Activity of Daily Living
Recorded at an ADL interview to assess the performance of everyday activities
Measured: Assessed at baseline, after 6 weeks, after 6 month and after one year
Number of total hospital admissions
Measured: at baseline, after 6 weeks, after 6 month and after one year
Exercise Compliance
registration of exercise
Measured: at baseline, after 6 weeks, after 6 month and after one year
Anxiety and depression
measured by Hospital Anxiety and Depression Scale (HAD)
Measured: at baseline, after 6 weeks, after 6 month and after one year
Quality of life
measured by The Minnesota Living with Heart Failure Questionnaire
Measured: at baseline, after 6 weeks, after 6 month and after one year
Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
Measured: at 6 weeks, after 6 month and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Staun Valentiner, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669395
- Sponsor's protocol ID
- H-2-2012-021
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01669395
- Acronym / sponsor ID
- H-2-2012-021
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early homebased rehabilitation | Experimental | Other: Early homebased rehabilitation after hospital admissionAfter discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks. |
| control group: Ususal care | Experimental | Other: Usual careAfter discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
- Patients with terminal illness with expected death within a year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early homebased rehabilitation after hospital admissionAlso: severe heart failure, homebased rehabilitation, physical exercise, activities of daily livingTraining 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 | Early homebased rehabilitation |
| Usual careAfter discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support | Other | control group: Ususal care |
Primary outcome
Readmission due to heart failure
Time frame: assessed one year after inclusion
7 secondary outcomes
Physical capacity
Time frame: Assessed at baseline, after 6 weeks, after 6 month and after one year
Activity of Daily Living
Time frame: Assessed at baseline, after 6 weeks, after 6 month and after one year
Number of total hospital admissions
Time frame: at baseline, after 6 weeks, after 6 month and after one year
Exercise Compliance
Time frame: at baseline, after 6 weeks, after 6 month and after one year
Anxiety and depression
Time frame: at baseline, after 6 weeks, after 6 month and after one year
Quality of life
Time frame: at baseline, after 6 weeks, after 6 month and after one year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Staun Valentiner, Master in health scien contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early homebased rehabilitation after hospital admission in people with Chronic Heart Failure and Heart Failure NYHA Class II, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Staun Valentiner, Master in health scien (+ 45 39 77 39 51, laura.risted.staun.valentiner@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission due to heart failure (time frame: assessed one year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.