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

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.

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.

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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