UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031843 |
|---|---|
| Receipt number | 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 11:45:19 |
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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
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
missy-y@umin.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036299
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
