- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01669395
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Laura Staun Valentiner, Master in health scien
- Telefonnummer: + 45 39 77 39 51
- E-post: laura.risted.staun.valentiner@regionh.dk
Studer Kontakt Backup
- Navn: Carsten Juhl, Ph.D.stud
- Telefonnummer: + 45 39 77 39 51
- E-post: carsten.juhl@regionh.dk
Studiesteder
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Gentofte
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Copenhagen, Gentofte, Danmark, 2900
- Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
-
Ta kontakt med:
- Laura Staun Valentiner, masters in health sciences
- Telefonnummer: + 45 39 77 39 51
- E-post: laura.risted.staun.valentiner@regionh.dk
-
Ta kontakt med:
- Carsten Juhl, Ph.D stud.
- Telefonnummer: + 45 39 77 39 51
- E-post: carsten.juhl@regionh.dk
-
Hovedetterforsker:
- Laura Staun Valentiner, Masters in Health Science
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Early homebased rehabilitation
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
|
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
Andre navn:
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Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Readmission due to heart failure
Tidsramme: assessed one year after inclusion
|
assessed one year after inclusion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Physical capacity
Tidsramme: Assessed at baseline, after 6 weeks, after 6 month and after one year
|
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
|
Activity of Daily Living
Tidsramme: Assessed at baseline, after 6 weeks, after 6 month and after one year
|
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
|
Number of total hospital admissions
Tidsramme: at baseline, after 6 weeks, after 6 month and after one year
|
at baseline, after 6 weeks, after 6 month and after one year
|
|
Exercise Compliance
Tidsramme: at baseline, after 6 weeks, after 6 month and after one year
|
registration of exercise
|
at baseline, after 6 weeks, after 6 month and after one year
|
Anxiety and depression
Tidsramme: at baseline, after 6 weeks, after 6 month and after one year
|
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
Tidsramme: at baseline, after 6 weeks, after 6 month and after one year
|
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
|
Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
Tidsramme: at 6 weeks, after 6 month and after one year
|
at 6 weeks, after 6 month and after one year
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-2-2012-021
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