Trial Outcomes & Findings for Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial (NCT NCT02591511)

NCT ID: NCT02591511

Last Updated: 2018-09-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2018-09-14

Participant Flow

Participant milestones

Measure	Health-education App 1. assisting the subjects in installing the app onto their personal smartphones; 2. teaching the patients about the content of the app and explaining its method of operation	Health Education Manuals 1. giving the stroke-related health education manuals to subjects; 2. teaching the patients about the content of the manual.
Overall Study STARTED	30	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Health-education App n=30 Participants (1) assisting the subjects in installing the app onto their personal smartphones; (2) teaching the patients about the content of the app and explaining its method of operation.	Health Education Manuals n=33 Participants (1) giving the stroke-related health education manuals to subjects; (2) teaching the patients about the content of the manual.	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	50.47 years STANDARD_DEVIATION 10.82 • n=5 Participants	52.33 years STANDARD_DEVIATION 11.33 • n=7 Participants	51.40 years STANDARD_DEVIATION 11.08 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment Taiwan	30 participants n=5 Participants	33 participants n=7 Participants	63 participants n=5 Participants
Stroke knowledge questionnaire	26.23 participants STANDARD_DEVIATION 6.65 • n=5 Participants	25.21 participants STANDARD_DEVIATION 5.54 • n=7 Participants	25.72 participants STANDARD_DEVIATION 6.10 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Health-education App n=30 Participants (1) assisting the subjects in installing the app onto their personal smartphones; (2) teaching the patients about the content of the app and explaining its method of operation.	Health Education Manuals n=33 Participants (1) giving the stroke-related health education manuals to subjects; (2) teaching the patients about the content of the manual.
Stroke Health Education Knowledge Questionnaire	29.07 score on a scale Standard Deviation 5.27	28.00 score on a scale Standard Deviation 5.46

Adverse Events

Health-education App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Education Manual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chia-Yun Lin

Taipei medical university

Phone: +886919986391

Email: windoct@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60