- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02591511
Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial
August 16, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke Health Education Knowledge Questionnaire
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Wen-Hsuan Hou, PHD, Taipei Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
October 28, 2015
First Submitted That Met QC Criteria
October 28, 2015
First Posted (Estimate)
October 29, 2015
Study Record Updates
Last Update Posted (Actual)
September 14, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Taipei Medical University
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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