- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01580072
Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)
REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Carintha
-
Kötschach, Carintha, Østrig, 9640
- LKH Laas
-
-
Carinthia
-
Klagenfurt, Carinthia, Østrig, 9020
- Klinikum Klagenfurt
-
Villach, Carinthia, Østrig, 9500
- LKH Villach
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- COPD 3 or 4
- Be able to use the system provided
- Life expectancy > 12 months
Exclusion Criteria:
Studieplan
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 |
|---|---|
|
Ingen indgriben: Control group
Participants in the control group receive usual care.
|
|
|
Eksperimentel: Self monitoring for patients with COPD
|
Intervention Group entering vital parameters via Web Portal or automatic call center.
|
|
Eksperimentel: Nurse monitoring for patients with COPD
|
Nurses are entering vital parameters of the patient with mobile devices.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.
Tidsramme: 12 months
|
Baseline analyses and analyses after 12 months were conducted.
Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported.
A high score defines a more favorable health state, items are scored on a 0 to 100 range.
Scale scores represent the average for all items in the scale that the respondent answered.
|
12 months
|
|
Number of Inpatient Stays
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Bed Days for Hospitalised Patients
Tidsramme: 12 months
|
12 months
|
|
|
Number of Primary Care Visits
Tidsramme: 12 months
|
Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.
|
12 months
|
|
Number of Specialist Visits
Tidsramme: 12 months
|
12 months
|
|
|
Number of Consultations of Emergency Doctor
Tidsramme: 12 months
|
12 months
|
|
|
All Cause Mortality
Tidsramme: 12 months
|
deceased patients in respect to participating patients, by obituary column
|
12 months
|
|
COPD Assessment Test CAT (Carinthia)
Tidsramme: 12 months
|
No data available
|
12 months
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
Tidsramme: 12 months
|
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores are calculated for three domains: Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos |
12 months
|
|
BODE Index (Carinthia)
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C250487
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