Multimedia Learning EducationNCT04966286
The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
A study testing multimedia education in people with Multimedia Learning Education and Self-care, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Multimedia Learning Education, Self-care, Quality of Life
- What is being tested?
- multimedia education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 31 Mar 2019
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≧ 20
- Operation with ostomy
Who cannot join
- Dementia, mental illness, and central nervous system diseases
- Unable self-care
- Visual or hearing impairs
Trial locations and contacts
1 site in 1 country.
About this study
This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.
Read the detailed description
In a systematic review, evaluated the effectiveness of multimedia education program (MLEP) and confirmed that MLEP reduced cost significantly and improved patient participation in enterostomy care and self-care ability. However, research was insufficient for whether a multimedia education program (MLEP) interventions can improve patient self-care and quality of life.
- Conditions
- Multimedia Learning Education, Self-care, Quality of Life, Enterostomy
- Being tested
- multimedia education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimedia educationOther
The MLEP intervention was based on a literature review of prior research on the content and format of self care related multimedia education programmes
| Study group | Role | What they receive |
|---|---|---|
| conventional education service program | Placebo comparator | received only standard enterostomy care brochure Receives: Other: multimedia education |
| multimedia education service program | Experimental | received multimedia education service program introduction Receives: Other: multimedia education |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care ability
Assessment scale of self-care ability of enterostomy care was a quantitative scale for nursing staff to evaluate self-care skills in patients with enterostomy. It consisted of 7 items related to: Prepare items, removing the pouching system, measuring the enterostomy diameter, adjusting the size of the enterostomy diameter in a new stoma appliance, skin care, fitting a new enterostomy appliance, and emptying procedure. Each skill was rated on a 4-point scale: Likert scale (1: not at all, 2: some, 3: quite a lot, 4: very much).
Higher scores indicated that patient had a higher level of self-care skills for changing enterostomy pouching system
Measured: One and a half years
Secondary outcomes (1)
Promote quality of life
The Enterostomy quality of life was comprised of 30 questionnaires, it covered seven domains: relations with family and friends, Sleep, activity, sexual activity, social relationship, physiology and psychology. The responses rated on a4-point scale Likert scale (1: extremely, 2: quite a lot, 3: somewhat, 4: not at all). The possible scores range was from 37 to 148. Higher scores indicated that patient had a higher level of quality of life
Measured: One and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jun 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multimedia Learning EducationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966286
- Sponsor's protocol ID
- 7425
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
- ClinicalTrials.gov ID
- NCT04966286
- Acronym / sponsor ID
- 7425
- Conditions
- Multimedia Learning Education, Self-care, Quality of Life, Enterostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 19 Jul 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.
This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.
Detailed description
In a systematic review, evaluated the effectiveness of multimedia education program (MLEP) and confirmed that MLEP reduced cost significantly and improved patient participation in enterostomy care and self-care ability. However, research was insufficient for whether a multimedia education program (MLEP) interventions can improve patient self-care and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional education service program | Placebo comparator | Other: multimedia educationreceived only standard enterostomy care brochure |
| multimedia education service program | Experimental | Other: multimedia educationreceived multimedia education service program introduction |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≧ 20
- Operation with ostomy
Key exclusion criteria (3 listed)
- Dementia, mental illness, and central nervous system diseases
- Unable self-care
- Visual or hearing impairs
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 |
|---|---|---|
| multimedia educationThe MLEP intervention was based on a literature review of prior research on the content and format of self care related multimedia education programmes | Other | conventional education service program, multimedia education service program |
Primary outcome
self-care ability
Time frame: One and a half years
Assessment scale of self-care ability of enterostomy care was a quantitative scale for nursing staff to evaluate self-care skills in patients with enterostomy. It consisted of 7 items related to: Prepare items, removing the pouching system, measuring the enterostomy diameter, adjusting the size of the enterostomy diameter in a new stoma appliance, skin care, fitting a new enterostomy appliance, and emptying procedure. Each skill was rated on a 4-point scale: Likert scale (1: not at all, 2: some, 3: quite a lot, 4: very much). Higher scores indicated that patient had a higher level of self-care skills for changing enterostomy pouching system
1 secondary outcome
Promote quality of life
Time frame: One and a half years
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 19 Jul 2021.
- 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 multimedia education in people with Multimedia Learning Education and Self-care, run by Chang Gung Memorial 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 2 inclusion and 3 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 19 Jul 2021. 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. Some participants in this study may receive a placebo. 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 ability (time frame: One and a half years). 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 19 Jul 2021.