CClinicalTrials.gg
CompletedNCT02591511Updated Sep 14, 2018Results posted

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

An interventional study of smart phone and pad and stroke-related health education manual in Health Education, sponsored by Taipei Medical University. Completed. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-14.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Health Education
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In context

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    health-education app

    Smart phone and pad is a stroke-related health education app intervention group

    Device: smart phone and pad

  • Active comparator
    health education manuals

    stroke-related health education manual control group

    Other: stroke-related health education manual

Interventions

  • Devicesmart phone and pad

    Smart phone and pad is the mobile include the smart phone and pad, that can download the APP from internet.

  • Otherstroke-related health education manual

    stroke-related health education manual is the manual mainly contained information regarding the prevention of stroke risk factors.

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What researchers measure

Primary outcomes

  1. Stroke Health Education Knowledge Questionnaire

    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.

    Time frame: 4 weeks

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Results

Posted Sep 14, 2018

Participant flow

Participant flow — Overall Study
MilestoneHealth-education AppHealth Education Manuals
Started3033
Completed3033
Not completed00

Outcome measures

PrimaryStroke Health Education Knowledge Questionnaire

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.

Time frame:
4 weeks
Reported as:
Mean · score on a scale
Stroke Health Education Knowledge Questionnaire
score on a scaleHealth-education AppHealth Education Manuals
Stroke Health Education Knowledge Questionnaire29.07 ± 5.2728.00 ± 5.46

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Health-education App0/30 (0%)0/30 (0%)0/30 (0%)
Health Education Manual0/33 (0%)0/33 (0%)0/33 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Health-education AppHealth Education ManualsTotal
<=18 years000
Between 18 and 65 years202343
>=65 years101020
Age, Continuous
Age, Continuous(years)Health-education AppHealth Education ManualsTotal
Mean50.47 ± 10.8252.33 ± 11.3351.40 ± 11.08
Sex: Female, Male
Sex: Female, Male(Participants)Health-education AppHealth Education ManualsTotal
Female91120
Male212243
Region of Enrollment
Region of Enrollment(participants)Health-education AppHealth Education ManualsTotal
Taiwan303363
Stroke knowledge questionnaire
Stroke knowledge questionnaire(participants)Health-education AppHealth Education ManualsTotal
Mean26.23 ± 6.6525.21 ± 5.5425.72 ± 6.10
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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 34813082 ↗
  • 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. PubMed 31864348 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02591511
Lead sponsor
Taipei Medical University
Responsible party
Sponsor
First posted
Oct 29, 2015
Start date
Oct 2015
Primary completion
Oct 2016
Completion
Oct 2016
Results posted
Sep 14, 2018
Last update
Sep 14, 2018

Study contacts

Wen-Hsuan Hou, PHD
study chair · Taipei Medical University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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