HealthyNCT03638934
Efficacy of Self-education Program for Advanced Care Planning(RCT) for General Population
A study testing Videos about ACP and Brochure about Life-Sustaining Treatment Act in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study verifies efficacy of Self-education program for advanced care planning in general population. Half of participants will receive a 20 minutes video about advanced care planning while the other half will receive a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Videos about ACP and Brochure about Life-Sustaining Treatment Act
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2018to 25 May 2018
- 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
- Subject 20 years old and more
- Subject who understands the purpose of the study and signs with informed consent form
Who cannot join
- Inability to speak, understand, or write Korean
- Inability to understand the contents of the provided materials due to poor eyesight and hearing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Decision Aid for Advanced Care Planning(RCT) for General Population: Randomized Controlled Trial
This study verifies efficacy of Self-education program for advanced care planning in general population. Half of participants will receive a 20 minutes video about advanced care planning while the other half will receive a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act.
Read the detailed description
This study validates effectiveness of decision aid that the investigators developed due to the rates of completing Advanced care planning are considerably low, which is led by the lack of information available to general population; whether they elevate the preference of healthy general population toward Advanced Care planning, reduce the burden of decision making, and support general population to overcome their crisis, compare to educational resources that are currently available.
Previous studies inform that educational video about advanced care planning increases the knowledge of care for life prolongation and affects the preference towards care for life prolongation and palliative care. However, previous studies focused mainly on patient populations, and the general population might differ in its understanding of disease, health care services, and ACP. In this study, we constructed ACP video decision support materials for the general population and compared their effectiveness in an RCT.
Primary outcome of this study is attitude and behavior change toward advanced care planning. Participants of this study will fill out the baseline questionnaire about ACP preference, end-of-life care preference, knowledge of ACP, etc. After that, participants will be allocated equally into the intervention group and the control group. Participants assigned to the intervention arm viewed the 20-minute educational decision support video entitled Advance Care Planning, which had been used and tested in studies with advanced cancer patients. Participants randomized to the attention-control arm received and read a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act, which was developed by the Ministry of Health and Welfare. After reading and watching the educational materials, patients will get another questionnaire about knowledge of ACP, satisfaction on the materials, ACP Preference, etc.
- Conditions
- Healthy
- Being tested
- Videos about ACP, Brochure about Life-Sustaining Treatment Act
- Keywords
- Advance care planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videos about ACPOther
Three videos about advanced care planning are provided for self-education.
Brochure about Life-Sustaining Treatment ActOther
Brochure about Life-Sustaining Treatment Act are provided for self-education.
| Study group | Role | What they receive |
|---|---|---|
| Videos about ACP | Experimental | Subjects in experimental group get three videos about advanced care planning based on Smart Management Strategy for Health (SMASH). After they finish watching the materials, they fill out the questionnaire. Receives: Other: Videos about ACP |
| Brochure for Life-Sustaining Treatment | Active comparator | Subjects in the group get 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act. After they finish watching the materials, they fill out the questionnaire. Receives: Other: Brochure about Life-Sustaining Treatment Act |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Advance Care Preference
Comparison the result of Advance Care Preference questionnaire
Measured: Baseline, within 1 week
Secondary outcomes (6)
Changes in Hospital Anxiety and Depression Scale
Comparison the result of Hospital Anxiety and Depression Scale questionnaire
Measured: Baseline, within 1 week
Changes in CPR knowledge
Comparison the result of Changes in CPR knowledge questionnaire
Measured: Baseline, within 1 week
Changes in palliative care / advance care planning knowledge score
Comparison the result of Changes in palliative care / advance care planning knowledge score questionnaire
Measured: Baseline, within 1 week
Changes in No CPR preference in terminal status
Comparison the result of No CPR preference in terminal status questionnaire
Measured: Baseline, within 1 week
Changes in End-of-Life care
Comparison the result of End-of-Life care preference questionnaire
Measured: Baseline, within 1 week
Satisfaction on educational materials
The result of Satisfaction on educational materials questionnaire
Measured: Baseline, within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start27 Apr 2018
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, National Evidence-Based Healthcare Collaborating Agency
- Responsible party
- Principal investigator, Young Ho Yun, Seoul National University Hospital
- Investigators
- Young Ho Yun, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638934
- Sponsor's protocol ID
- HC15C1391-4
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Decision Aid for Advanced Care Planning(RCT) for General Population: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03638934
- Acronym / sponsor ID
- HC15C1391-4
- Conditions
- Healthy
- Keywords
- Advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, National Evidence-Based Healthcare Collaborating Agency
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 20 Aug 2018 (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 study verifies efficacy of Self-education program for advanced care planning in general population. Half of participants will receive a 20 minutes video about advanced care planning while the other half will receive a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act.
Detailed description
This study validates effectiveness of decision aid that the investigators developed due to the rates of completing Advanced care planning are considerably low, which is led by the lack of information available to general population; whether they elevate the preference of healthy general population toward Advanced Care planning, reduce the burden of decision making, and support general population to overcome their crisis, compare to educational resources that are currently available.
Previous studies inform that educational video about advanced care planning increases the knowledge of care for life prolongation and affects the preference towards care for life prolongation and palliative care. However, previous studies focused mainly on patient populations, and the general population might differ in its understanding of disease, health care services, and ACP. In this study, we constructed ACP video decision support materials for the general population and compared their effectiveness in an RCT.
Primary outcome of this study is attitude and behavior change toward advanced care planning. Participants of this study will fill out the baseline questionnaire about ACP preference, end-of-life care preference, knowledge of ACP, etc. After that, participants will be allocated equally into the intervention group and the control group. Participants assigned to the intervention arm viewed the 20-minute educational decision support video entitled Advance Care Planning, which had been used and tested in studies with advanced cancer patients. Participants randomized to the attention-control arm received and read a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act, which was developed by the Ministry of Health and Welfare. After reading and watching the educational materials, patients will get another questionnaire about knowledge of ACP, satisfaction on the materials, ACP Preference, etc.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Videos about ACP | Experimental | Other: Videos about ACPSubjects in experimental group get three videos about advanced care planning based on Smart Management Strategy for Health (SMASH). After they finish watching the materials, they fill out the questionnaire. |
| Brochure for Life-Sustaining Treatment | Active comparator | Other: Brochure about Life-Sustaining Treatment ActSubjects in the group get 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act. After they finish watching the materials, they fill out the questionnaire. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject 20 years old and more
- Subject who understands the purpose of the study and signs with informed consent form
Key exclusion criteria (2 listed)
- Inability to speak, understand, or write Korean
- Inability to understand the contents of the provided materials due to poor eyesight and hearing
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 |
|---|---|---|
| Videos about ACPThree videos about advanced care planning are provided for self-education. | Other | Videos about ACP |
| Brochure about Life-Sustaining Treatment ActBrochure about Life-Sustaining Treatment Act are provided for self-education. | Other | Brochure for Life-Sustaining Treatment |
Primary outcome
Changes in Advance Care Preference
Time frame: Baseline, within 1 week
Comparison the result of Advance Care Preference questionnaire
6 secondary outcomes
Changes in Hospital Anxiety and Depression Scale
Time frame: Baseline, within 1 week
Changes in CPR knowledge
Time frame: Baseline, within 1 week
Changes in palliative care / advance care planning knowledge score
Time frame: Baseline, within 1 week
Changes in No CPR preference in terminal status
Time frame: Baseline, within 1 week
Changes in End-of-Life care
Time frame: Baseline, within 1 week
Satisfaction on educational materials
Time frame: Baseline, within 1 week
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 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Young Ho Yun principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videos about ACP and Brochure about Life-Sustaining Treatment Act in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 Aug 2018. 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 South Korea. 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?
Changes in Advance Care Preference (time frame: Baseline, within 1 week). 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 Aug 2018.