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

NCT ID: NCT03638934

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2018-05-25

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Videos about ACP

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.

Group Type EXPERIMENTAL

Videos about ACP

Intervention Type OTHER

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

Brochure for Life-Sustaining Treatment

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.

Group Type ACTIVE_COMPARATOR

Brochure about Life-Sustaining Treatment Act

Intervention Type OTHER

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

Interventions

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Videos about ACP

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

Intervention Type OTHER

Brochure about Life-Sustaining Treatment Act

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Health, Korea

OTHER_GOV

Sponsor Role collaborator

National Clinical Research Coordination Center, Seoul, Korea

OTHER_GOV

Sponsor Role collaborator

National Evidence-Based Healthcare Collaborating Agency

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Ho Yun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Ho Yun

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HC15C1391-4

Identifier Type: -

Identifier Source: org_study_id

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