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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031843
Receipt No. R000036299
Scientific Title Use of Video to Facilitate Advance Care Planning with Elderly Home-bound Patients with Non cancer Disease: Randomized Control Trial
Date of disclosure of the study information 2018/03/26
Last modified on 2021/03/29

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Basic information
Public title Use of Video to Facilitate Advance Care Planning with Elderly Home-bound Patients with Non cancer Disease: Randomized Control Trial
Acronym JACP video study
Scientific Title Use of Video to Facilitate Advance Care Planning with Elderly Home-bound Patients with Non cancer Disease: Randomized Control Trial
Scientific Title:Acronym JACP video study
Region
Japan

Condition
Condition Chronic disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines the impact of a video decision support tool on advance care planning for elderly home-bound patients with chronic disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Goal-of-care preferences(life-prolonging care, limited medical care, comfort care, not sure) and CPR preferences (attempt CPR, do not attempt CPR, not sure) in 1 month after verbal narrative describing treatment options and CPR (control group) or verbal narrative and viewing a decision support video(intervention group).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 At the first visit on a patient
Intervention; Verbal narrative and viewing an Advance Care Planning Video Decision Support Tool

Interventions/Control_2 At the first visit on a patient
Control: Verbal narrative only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient:
Age>=65 years
Main diagnosis is chronic disease (non cancer)
Has been seen by a current home care provider more than 1 month
Current home care provider confirms a patient has ability to understand and choose treatment options
Ability to provide informed consent

Physician:
Provides home care for patients in this study
Ability to provide informed consent

Key exclusion criteria Patient:
Considered to be inappropriate per physician
Everyday life independence of the attending physician statement of elderly people with dementia>=2
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takemura
Middle name
Last name Yousuke
Organization Mie University School of Medicine & Graduate School of Medicine
Division name Department of Education and Research in Family and Community Medicine
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie 514-8507
TEL 059-231-5290
Email yousuke@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Misuzu
Middle name
Last name Yuasa
Organization Mie University School of Medicine & Graduate School of Medicine
Division name Department of Education and Research in Family and Community Medicine
Zip code 5148507
Address 2-174 Edobashi, Tsu, Mie
TEL 059-231-5290
Homepage URL
Email missy-y@umin.ac.jp

Sponsor
Institute Mie University
Institute
Department

Funding Source
Organization Mie University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mie University
Address 2-174 Edobashi, Tsu, Mie 514-8507
Tel 059-231-5045
Email s-kenkyu@mo.medic.mie-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 22 Day
Last modified on
2021 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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