- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02591511
Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial
16. august 2018 opdateret af: Taipei Medical University
Effects of Health-education Application on Improving Stroke-related Knowledge and Health Related Quality of Life in Patients With Stroke: a Randomized Controlled Trial
The aim of this study is to establish PAtient-Centered Computerized Educating System for Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the intervention group will receive the PACCESS and the control groups will receive traditional health education to test the effects of PACCESS in increasing clinical decision-making, health behavior, activities of daily living and knowledge of stroke, and health care quality.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To prevent recurrent stroke and improve the health-related quality of life (HRQOL) in patients with stroke, education regarding the risk factors of recurrent stroke is a crucial part of effective care for patients with stroke.
The aim of this study was to develop an application capable of providing health education for recurrent-stroke prevention.
We also examined the effectiveness of this app for improving stroke-related knowledge and HRQOL in patients with stroke.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
63
Fase
- Ikke anvendelig
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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- first time diagnosis of stroke (International Classification of Diseases, ninth revision, clinical modification [ICD-9] codes) of cerebral hemorrhage (ICD-9, 431) or cerebral infarction (ICD 9, 434)
- ability to follow instructions and complete the interviews
- having a designated caregiver who agrees to participate in the survey
- >6 years of education
- have smartphone or the other mobile device can download the APP from internet.
Exclusion Criteria:
- cognitive impairment (Mini-Mental State Examination (MMSE scores<24)
- having major mental diseases (i.e., depression, dementia, delirium, etc.)
- the inability to read/answer questionnaires
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: health-education app
Smart phone and pad is a stroke-related health education app intervention group
|
Smart phone and pad is the mobile include the smart phone and pad, that can download the APP from internet.
|
|
Aktiv komparator: health education manuals
stroke-related health education manual control group
|
stroke-related health education manual is the manual mainly contained information regarding the prevention of stroke risk factors.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Stroke Health Education Knowledge Questionnaire
Tidsramme: 4 weeks
|
The stroke knowledge questionnaire is the primary outcome of this study.
The questions are single-choice questions.
The content of the questions are based on the stroke health education manual and adapted to APP format in this study.
For the 12 risk factors, each risk factor was sorted out 3 questions.
There are total of 36 (3x12 = 36) questions of stroke knowledge, a score of 1 for each question, the highest score of 3 for each risk factor, the highest score of 36 points and the lowest score of 0 point.
The higher score represents the better outcome.
|
4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Wen-Hsuan Hou, PHD, Taipei Medical University
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.
Generelle publikationer
- Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Kang YN, Shen HN, Lin CY, Elwyn G, Huang SC, Wu TF, Hou WH. Does a Mobile app improve patients' knowledge of stroke risk factors and health-related quality of life in patients with stroke? A randomized controlled trial. BMC Med Inform Decis Mak. 2019 Dec 21;19(1):282. doi: 10.1186/s12911-019-1000-z.
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. oktober 2015
Primær færdiggørelse (Faktiske)
1. oktober 2016
Studieafslutning (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
28. oktober 2015
Først indsendt, der opfyldte QC-kriterier
28. oktober 2015
Først opslået (Skøn)
29. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. august 2018
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Taipei Medical University
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 .