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

16 augusti 2012 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Danmark
    • Gentofte
      • Copenhagen, Gentofte, Danmark, 2900
        • Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Laura Staun Valentiner, Masters in Health Science

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Early homebased rehabilitation
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
Övrig: 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
Andra namn:
  • motion
  • severe heart failure
  • homebased rehabilitation
  • activities of daily living
Experimentell: control group: Ususal care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
Övrig: Usual care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Readmission due to heart failure
Tidsram: assessed one year after inclusion
assessed one year after inclusion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical capacity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: at baseline, after 6 weeks, after 6 month and after one year
measured by Hospital Anxiety and Depression Scale (HAD)
at baseline, after 6 weeks, after 6 month and after one year
Quality of life
Tidsram: at baseline, after 6 weeks, after 6 month and after one year
measured by The Minnesota Living with Heart Failure Questionnaire
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)
Tidsram: at 6 weeks, after 6 month and after one year
at 6 weeks, after 6 month and after one year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Gentofte, Copenhagen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2012

Primärt slutförande (Förväntat)

1 september 2015

Avslutad studie (Förväntat)

1 juli 2016

Studieregistreringsdatum

Först inskickad

14 augusti 2012

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2012

Första postat (Uppskatta)

21 augusti 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

21 augusti 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 augusti 2012

Senast verifierad

1 augusti 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H-2-2012-021

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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