Effectiveness of Application Education InterventionNCT04713020
Application of Educational Intervention on the Knowledge, Depression and Self-efficacy of Patients With Cerebrovascular Accident
A study testing Intervention:APP educational programs in people with Effectiveness of Application Education Intervention, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Within 6 months after the occurrence of stroke, more than 25% of patients will experience severe disability. Patients and caregivers need to learn stroke self-care knowledge. Nursing personnel play the role of educator and provide self-care health education content. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of Application Education Intervention
- What is being tested?
- Intervention:APP educational programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 20 years of age
- A clear state of consciousness
- No diagnosis of mental or cognitive diseases
- Normal hearing and vision
- Able to communicate in Chinese and Taiwanese
- Able to use Digital mobile phone and agree to participate in this research.
Who cannot join
- Suffer from mental illness and cognitive dysfunction
- Visual impairment, hard of hearing
- Combined with other complications, such as: pneumonia, urinary tract infection, etc. ‧
- Unwilling to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Taiwan University Hospital
Within 6 months after the occurrence of stroke, more than 25% of patients will experience severe disability. Patients and caregivers need to learn stroke self-care knowledge. Nursing personnel play the role of educator and provide self-care health education content. Traditional nursing instructions are mainly provided using leaflets and verbal health education. However, the advancement of information technology and the popularization of mobile network 3C products make it possible to provide real-time, individualized and large-capacity information, which is the most real-time and efficient way of clinical care at present. Therefore, this study investigated whether mobile device health education program provided for patients with stroke can improve their self-care knowledge and self-efficacy and reduce depression.
This study enrolled patients at the wards of Division of Neurology in a certain medical center in the northern Taiwan. This study adopted two-group, pre-and-post-test, randomized, single-blind experimental research design, and calculated the samples size using G-Power. At least 35 subjects should be enrolled in the experimental group (APP education program intervention) and control group (conventional nursing), respectively. This study performed the pre-test on Day 1 of hospitalization, implemented the interventional program on Day 2, and performed the post-test before discharge. The research questionnaires included Stroke Self-care Knowledge Scale, Stroke Self-efficacy Scale, Beck Depression Inventory (BDI), VAS Health Education Satisfaction Scale. This study performed statistical analysis using the package statistical software version SPSS 20.0, and tested the distribution and homogeneity of two groups of data using the independent sample T-test. Moreover, this study also performed descriptive statistical analysis and inferential statistical analysis. For the descriptive statistical analysis, this study presented the demographic data and disease characteristics of the research subjects using frequency distribution, percentage, average mean, standard deviation, maximum and minimum. Furthermore, this study used independent sample T-test, chi-square, One-way ANOVA, Pearson product-moment correlation coefficient, and ANCOVA to compare the differences in demographic data, disease characteristics, stroke self-care knowledge, stroke self-efficacy, depression, and health education satisfaction between the two groups.
Read the detailed description
In a large teaching hospital in Asia, stroke patients were divided into experimental group and control group by random allocation. The experimental group was given a mobile device education program, and the control group was routine nursing care. Two groups of stroke were discussed. Whether there are significant differences in knowledge, depression assessment, and self-efficacy assessment.
Hopefully, the intervention of mobile device education program can provide patients with a health education method that is accessible and can be repeatedly watched for learning. Hopefully, this education program may replace traditional health education leaflet, as well as reduce the workload of clinical nurses. It is hoped that this education program can effectively improve the self-care knowledge of patients with stroke, enhance self-efficacy, reduce depression symptoms, increase satisfaction with educational instructions, and ultimately prevent patients with stroke from experiencing any relapse to coexist with their stroke and enjoy a good quality of life.
- Being tested
- Intervention:APP educational programs, No Intervention:general care
- Keywords
- Education Program, Stroke, Self-care Knowledge, Self-efficacy, Depression
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention:APP educational programsOther
Also called educational programs
Use mobile device education programs to improve disease knowledge and self-efficacy of stroke patients, and reduce depression
No Intervention:general careOther
general care
| Study group | Role | What they receive |
|---|---|---|
| Effectiveness of Application Education Intervention | Experimental | This study hopes that through the intervention of mobile device education programs, it can provide patients with easy access and repeated viewing and learning. It can replace traditional leaflet health education and reduce the workload of clinical nurses. It is hoped that it can effectively improve the self-care knowledge of stroke patients, improve self-efficacy, reduce the symptoms of depression, and increase the satisfaction of education and guidance. Eventually, patients can be prevented from recurring from stroke, and they can coexist peacefully with stroke and have a good quality of life. Receives: Other: Intervention:APP educational programs |
| genaral care | Other | Give patients routine care Receives: Other: No Intervention:general care |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care knowledge
I hope that the use of APP health education can improve the cognitive knowledge of stroke patients, Use the stroke knowledge scale to evaluate.
There are a total of 16 questions on this scale. You get one point for correct answers. If you answer incorrectly or don't know you don't give points. The maximum score for this scale is 16.The higher the score on this scale, the better the knowledge of stroke
Measured: one year
self-efficacy
Hope that using APP health education can improve the self-efficacy of stroke patients, Use the stroke self-efficacy scale to evaluate.
There are a total of 13 questions on this scale, with a total score of 10 points for a completely certain answer and 0 points for a completely unsure answer. The total score is 130.The higher the score on this scale, the better the self-efficacy of stroke
Measured: one year
depression
Hope that using APP health education can reduce the depression of stroke patients,Use the BDI scale to evaluate.
The higher the score on this scale, the higher the depression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Application Education InterventionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713020
- Sponsor's protocol ID
- 202006127RINB
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT04713020
- Acronym / sponsor ID
- 202006127RINB
- Keywords
- Education Program, Stroke, Self-care Knowledge, Self-efficacy, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Within 6 months after the occurrence of stroke, more than 25% of patients will experience severe disability. Patients and caregivers need to learn stroke self-care knowledge. Nursing personnel play the role of educator and provide self-care health education content. Traditional nursing instructions are mainly provided using leaflets and verbal health education. However, the advancement of information technology and the popularization of mobile network 3C products make it possible to provide real-time, individualized and large-capacity information, which is the most real-time and efficient way of clinical care at present. Therefore, this study investigated whether mobile device health education program provided for patients with stroke can improve their self-care knowledge and self-efficacy and reduce depression.
This study enrolled patients at the wards of Division of Neurology in a certain medical center in the northern Taiwan. This study adopted two-group, pre-and-post-test, randomized, single-blind experimental research design, and calculated the samples size using G-Power. At least 35 subjects should be enrolled in the experimental group (APP education program intervention) and control group (conventional nursing), respectively. This study performed the pre-test on Day 1 of hospitalization, implemented the interventional program on Day 2, and performed the post-test before discharge. The research questionnaires included Stroke Self-care Knowledge Scale, Stroke Self-efficacy Scale, Beck Depression Inventory (BDI), VAS Health Education Satisfaction Scale. This study performed statistical analysis using the package statistical software version SPSS 20.0, and tested the distribution and homogeneity of two groups of data using the independent sample T-test. Moreover, this study also performed descriptive statistical analysis and inferential statistical analysis. For the descriptive statistical analysis, this study presented the demographic data and disease characteristics of the research subjects using frequency distribution, percentage, average mean, standard deviation, maximum and minimum. Furthermore, this study used independent sample T-test, chi-square, One-way ANOVA, Pearson product-moment correlation coefficient, and ANCOVA to compare the differences in demographic data, disease characteristics, stroke self-care knowledge, stroke self-efficacy, depression, and health education satisfaction between the two groups.
Detailed description
In a large teaching hospital in Asia, stroke patients were divided into experimental group and control group by random allocation. The experimental group was given a mobile device education program, and the control group was routine nursing care. Two groups of stroke were discussed. Whether there are significant differences in knowledge, depression assessment, and self-efficacy assessment.
Hopefully, the intervention of mobile device education program can provide patients with a health education method that is accessible and can be repeatedly watched for learning. Hopefully, this education program may replace traditional health education leaflet, as well as reduce the workload of clinical nurses. It is hoped that this education program can effectively improve the self-care knowledge of patients with stroke, enhance self-efficacy, reduce depression symptoms, increase satisfaction with educational instructions, and ultimately prevent patients with stroke from experiencing any relapse to coexist with their stroke and enjoy a good quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effectiveness of Application Education Intervention | Experimental | Other: Intervention:APP educational programsThis study hopes that through the intervention of mobile device education programs, it can provide patients with easy access and repeated viewing and learning. It can replace traditional leaflet health education and reduce the workload of clinical nurses. It is hoped that it can effectively improve the self-care knowledge of stroke patients, improve self-efficacy, reduce the symptoms of depression, and increase the satisfaction of education and guidance. Eventually, patients can be prevented from recurring from stroke, and they can coexist peacefully with stroke and have a good quality of life. |
| genaral care | Other | Other: No Intervention:general careGive patients routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 20 years of age
- A clear state of consciousness
- No diagnosis of mental or cognitive diseases
- Normal hearing and vision
- Able to communicate in Chinese and Taiwanese
Key exclusion criteria (4 listed)
- Suffer from mental illness and cognitive dysfunction
- Visual impairment, hard of hearing
- Combined with other complications, such as: pneumonia, urinary tract infection, etc. ‧
- Unwilling to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention:APP educational programsAlso: educational programsUse mobile device education programs to improve disease knowledge and self-efficacy of stroke patients, and reduce depression | Other | Effectiveness of Application Education Intervention |
| No Intervention:general caregeneral care | Other | genaral care |
Primary outcome
self-care knowledge
Time frame: one year
I hope that the use of APP health education can improve the cognitive knowledge of stroke patients, Use the stroke knowledge scale to evaluate. There are a total of 16 questions on this scale. You get one point for correct answers. If you answer incorrectly or don't know you don't give points. The maximum score for this scale is 16.The higher the score on this scale, the better the knowledge of stroke
self-efficacy
Time frame: one year
Hope that using APP health education can improve the self-efficacy of stroke patients, Use the stroke self-efficacy scale to evaluate. There are a total of 13 questions on this scale, with a total score of 10 points for a completely certain answer and 0 points for a completely unsure answer. The total score is 130.The higher the score on this scale, the better the self-efficacy of stroke
depression
Time frame: one year
Hope that using APP health education can reduce the depression of stroke patients,Use the BDI scale to evaluate. The higher the score on this scale, the higher the depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention:APP educational programs in people with Effectiveness of Application Education Intervention, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-care knowledge (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.