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Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise

28. februar 2017 opdateret af: Norwegian University of Science and Technology

Structured Patient Education in Combination With Physical Exercise as Part of the Integrated Care to Chronically Ill Patients With Chronic Obstructive Pulmonary Disease, Heart Failure and Stroke. A Randomized Controlled Intervention Trial.

This study addresses self management and maintenance of health through evaluation of a program of patient education in combination with physical training and with a structured follow-up.

It is hypothesized that such a program will:

  1. improve quality of life, physical functioning, coping in everyday-life
  2. reduce hospitalization and (re-)admissions for patients with chronic disease, reduce consumption of home care services and can increase consumption of general practice and physiotherapy services in primary health care.
  3. improve patient satisfaction and health care providers satisfaction

Studieoversigt

Detaljeret beskrivelse

Patients with chronically, long-lasting illness, have complex needs for treatment and care, which none of the service providers can fulfill on their own. Both patients and their relatives are in danger of experiencing severe lack of quality. Integrated care path programs are increasingly put into use. There is insufficient research-based documentation of the effect of such care paths.

The available documentation of different integrated care paths emphasizes early mobilization and discharge, rehabilitation in familiar surroundings, more effective communication and exchange of competence between the different service providers and educational self-management for patients as main elements in order to expect effect.

There are no studies that evaluate the effect of quality of life, functional skills and personal coping if group-based educational self management is combined with physical exercise and patients with different chronically illnesses participate in the same group.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Møre og Romsdal County
      • Surnadal, Møre og Romsdal County, Norge, 6650
        • Surnadal Municipality
    • Møre og Romsdal county
      • Sunndal, Møre og Romsdal county, Norge, 6600
        • Sunndal Municipality
    • Sør - Trøndelag
      • Klaebu, Sør - Trøndelag, Norge, 7540
        • Klæbu Municipality
    • Sør Trøndelag County
      • Trondheim, Sør Trøndelag County, Norge, 7000
        • Trondheim Municipality
    • Sør-Trøndelag County
      • Hitra, Sør-Trøndelag County, Norge, 7240
        • Hitra Municipality

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 45 years of age or more
  • Living at home
  • Capable of active participation in a group setting
  • Walking distance within 550 meter in 6 minutes
  • Chronic obstructive pulmonary disease (COPD) I-III
  • Chronic heart disease I-III
  • Stroke(0-2 on Modified Rankin Scale)

Exclusion Criteria:

  • Speaking and language problems or other substantial communication problems
  • Unstable medical or social situation
  • Participation in another science study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: exercise and education
Supervised physical exercise in groups, plus a self management education programme (patient education).

The structured patient educational self - management programme consists of 6 weekly sessions à 2 hours. The educational programme will take place prior to one of the two weekly training sessions.

After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care. During the last month of the intervention year educational self - management will be offered twice and focus on themes that the participants wish to refresh.

Aktiv komparator: exercise only
Supervised physical exercise in groups.
6 week waiting list, followed by two weekly training sessions. After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sundhedsrelateret livskvalitet
Tidsramme: Et år
Et år

Sekundære resultatmål

Resultatmål
Tidsramme
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Tidsramme: One year
One year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studieleder: Helge Garåsen, Norwegian University of Science and Technology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2009

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

30. september 2009

Først indsendt, der opfyldte QC-kriterier

2. oktober 2009

Først opslået (Skøn)

5. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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