Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
16 augustus 2012 bijgewerkt door: Laura Staun Valentiner, University Hospital, Gentofte, Copenhagen
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Gentofte
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Copenhagen, Gentofte, Denemarken, 2900
- Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Early homebased rehabilitation
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
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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
Andere namen:
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Experimenteel: control group: Ususal care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
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After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Readmission due to heart failure
Tijdsspanne: assessed one year after inclusion
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assessed one year after inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Physical capacity
Tijdsspanne: Assessed at baseline, after 6 weeks, after 6 month and after one year
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measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test
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Assessed at baseline, after 6 weeks, after 6 month and after one year
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Activity of Daily Living
Tijdsspanne: Assessed at baseline, after 6 weeks, after 6 month and after one year
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Recorded at an ADL interview to assess the performance of everyday activities
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Assessed at baseline, after 6 weeks, after 6 month and after one year
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Number of total hospital admissions
Tijdsspanne: at baseline, after 6 weeks, after 6 month and after one year
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at baseline, after 6 weeks, after 6 month and after one year
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Exercise Compliance
Tijdsspanne: at baseline, after 6 weeks, after 6 month and after one year
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registration of exercise
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at baseline, after 6 weeks, after 6 month and after one year
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Anxiety and depression
Tijdsspanne: at baseline, after 6 weeks, after 6 month and after one year
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measured by Hospital Anxiety and Depression Scale (HAD)
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at baseline, after 6 weeks, after 6 month and after one year
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Quality of life
Tijdsspanne: at baseline, after 6 weeks, after 6 month and after one year
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measured by The Minnesota Living with Heart Failure Questionnaire
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at baseline, after 6 weeks, after 6 month and after one year
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Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
Tijdsspanne: at 6 weeks, after 6 month and after one year
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at 6 weeks, after 6 month and after one year
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2012
Primaire voltooiing (Verwacht)
1 september 2015
Studie voltooiing (Verwacht)
1 juli 2016
Studieregistratiedata
Eerst ingediend
14 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
16 augustus 2012
Eerst geplaatst (Schatting)
21 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
21 augustus 2012
Laatste update ingediend die voldeed aan QC-criteria
16 augustus 2012
Laatst geverifieerd
1 augustus 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-2-2012-021
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