Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Health Education
• Interventions: Other: stroke-related health education manual; Device: smart phone and pad

• Registration Number: NCT02591511
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2018-05-30
• Results First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Results First Posted: 2018-09-14
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
health education manuals	stroke-related health education manual	stroke-related health education manual control group
health-education app	smart phone and pad	Smart phone and pad is a stroke-related health education app intervention group

Primary Outcome Measures

Name	Time	Method
Stroke Health Education Knowledge Questionnaire	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.