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

August 17, 2018 updated by: Young Ho Yun, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Videos about ACP
Three videos about advanced care planning are provided for self-education.
ACTIVE_COMPARATOR: 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.
Other: Brochure about Life-Sustaining Treatment Act
Brochure about Life-Sustaining Treatment Act are provided for self-education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Advance Care Preference
Time Frame: Baseline, within 1 week
Comparison the result of Advance Care Preference questionnaire
Baseline, within 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Hospital Anxiety and Depression Scale
Time Frame: Baseline, within 1 week
Comparison the result of Hospital Anxiety and Depression Scale questionnaire
Baseline, within 1 week
Changes in CPR knowledge
Time Frame: Baseline, within 1 week
Comparison the result of Changes in CPR knowledge questionnaire
Baseline, within 1 week
Changes in palliative care / advance care planning knowledge score
Time Frame: Baseline, within 1 week
Comparison the result of Changes in palliative care / advance care planning knowledge score questionnaire
Baseline, within 1 week
Changes in No CPR preference in terminal status
Time Frame: Baseline, within 1 week
Comparison the result of No CPR preference in terminal status questionnaire
Baseline, within 1 week
Changes in End-of-Life care
Time Frame: Baseline, within 1 week
Comparison the result of End-of-Life care preference questionnaire
Baseline, within 1 week
Satisfaction on educational materials
Time Frame: Baseline, within 1 week
The result of Satisfaction on educational materials questionnaire
Baseline, within 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Evidence-Based Healthcare Collaborating Agency
National Clinical Research Coordination Center, Seoul, Korea
National Institute of Health, Korea

Investigators

  • Principal Investigator: Young Ho Yun, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 27, 2018

Primary Completion (ACTUAL)

May 25, 2018

Study Completion (ACTUAL)

May 25, 2018

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HC15C1391-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Videos about ACP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe