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Efficacy of Self-education Program for Advanced Care Planning(RCT) for General Population

Efficacy of Decision Aid for Advanced Care Planning(RCT) for General Population: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03638934
Enrollment
250
Registered
2018-08-20
Start date
2018-04-27
Completion date
2018-05-25
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Advance care planning

Brief 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.

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.

Interventions

OTHERVideos about ACP

Three videos about advanced care planning are provided for self-education.

OTHERBrochure about Life-Sustaining Treatment Act

Brochure about Life-Sustaining Treatment Act are provided for self-education.

Sponsors

National Institute of Health, Korea
CollaboratorOTHER_GOV
National Clinical Research Coordination Center, Seoul, Korea
CollaboratorOTHER_GOV
National Evidence-Based Healthcare Collaborating Agency
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Subject 20 years old and more * Subject who understands the purpose of the study and signs with informed consent form

Exclusion criteria

* Inability to speak, understand, or write Korean * Inability to understand the contents of the provided materials due to poor eyesight and hearing

Design outcomes

Primary

MeasureTime frameDescription
Changes in Advance Care PreferenceBaseline, within 1 weekComparison the result of Advance Care Preference questionnaire

Secondary

MeasureTime frameDescription
Changes in CPR knowledgeBaseline, within 1 weekComparison the result of Changes in CPR knowledge questionnaire
Changes in palliative care / advance care planning knowledge scoreBaseline, within 1 weekComparison the result of Changes in palliative care / advance care planning knowledge score questionnaire
Changes in Hospital Anxiety and Depression ScaleBaseline, within 1 weekComparison the result of Hospital Anxiety and Depression Scale questionnaire
Changes in End-of-Life careBaseline, within 1 weekComparison the result of End-of-Life care preference questionnaire
Satisfaction on educational materialsBaseline, within 1 weekThe result of Satisfaction on educational materials questionnaire
Changes in No CPR preference in terminal statusBaseline, within 1 weekComparison the result of No CPR preference in terminal status questionnaire

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026