- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00989456
Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise
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:
- improve quality of life, physical functioning, coping in everyday-life
- 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.
- improve patient satisfaction and health care providers satisfaction
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Møre og Romsdal County
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Surnadal, Møre og Romsdal County, Norwegen, 6650
- Surnadal Municipality
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Møre og Romsdal county
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Sunndal, Møre og Romsdal county, Norwegen, 6600
- Sunndal Municipality
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Sør - Trøndelag
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Klaebu, Sør - Trøndelag, Norwegen, 7540
- Klæbu Municipality
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Sør Trøndelag County
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Trondheim, Sør Trøndelag County, Norwegen, 7000
- Trondheim Municipality
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Sør-Trøndelag County
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Hitra, Sør-Trøndelag County, Norwegen, 7240
- Hitra Municipality
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
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Aktiver Komparator: exercise only
Supervised physical exercise in groups.
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Gesundheitsbezogene Lebensqualität
Zeitfenster: Ein Jahr
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Ein Jahr
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Zeitfenster: One year
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One year
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Helge Garåsen, Norwegian University of Science and Technology
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Herzkrankheiten
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Erkrankungen der Atemwege
- Krankheitsattribute
- Herzfehler
- Streicheln
- Lungenkrankheit
- Lungenerkrankungen, obstruktive
- Lungenerkrankung, chronisch obstruktiv
- Chronische Erkrankung
Andere Studien-ID-Nummern
- 420082351
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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