NCT02591511

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 14, 2018

Completed
Last Updated

September 14, 2018

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 28, 2015

Results QC Date

May 30, 2018

Last Update Submit

August 16, 2018

Conditions

Health Education

Outcome Measures

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.

    4 weeks

Study Arms (2)

health-education app

EXPERIMENTAL

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

Device: smart phone and pad

health education manuals

ACTIVE COMPARATOR

stroke-related health education manual control group

Other: stroke-related health education manual

Interventions

smart phone and padDEVICE

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

health-education app
stroke-related health education manualOTHER

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

health education manuals

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34813082DERIVED

  • 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.

    PMID: 31864348DERIVED

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Chia-Yun Lin
Organization
Taipei medical university
windoct@hotmail.com
+886919986391

Study Officials

  • Wen-Hsuan Hou, PHD

    Taipei Medical University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 14, 2018

Results First Posted

September 14, 2018

Record last verified: 2015-10