- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Hälso-relaterad livskvalité
Tidsram: Ett år
|
Ett år
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Sustainability of the physiological effects of muscular training (6 Minutes Walk)
Tidsram: One year
|
One year
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: Helge Garåsen, Norwegian University of Science and Technology
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Luftvägssjukdomar
- Sjukdomsegenskaper
- Hjärtsvikt
- Stroke
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdom, kronisk obstruktiv
- Kronisk sjukdom
Andra studie-ID-nummer
- 420082351
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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