UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052366 |
|---|---|
| Receipt number | R000059781 |
| Scientific Title | Clinical Study on the Effectiveness of Introducing Advance Care Planning (ACP) in Older Adults in Response to COVID-19 (coronavirus disease 2019) |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/10/01 15:20:29 |
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Basic information
Public title
Clinical Study on the Effectiveness of Introducing Advance Care Planning (ACP) in Older Adults in Response to COVID-19 (coronavirus disease 2019)
Acronym
Clinical Study on the Effectiveness of Introducing Advance Care Planning in Older Adults in Response to COVID-19
Scientific Title
Clinical Study on the Effectiveness of Introducing Advance Care Planning (ACP) in Older Adults in Response to COVID-19 (coronavirus disease 2019)
Scientific Title:Acronym
Clinical Study on the Effectiveness of Introducing ACP in Older Adults in Response to COVID-19
Region
| Japan |
Condition
Condition
Geriatric diseases
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to demonstrate the effectiveness of introducing Advance Care Planning (ACP) using Serious Illness Care Program (SICP) discussions with elderly outpatient patients in the wake of the COVID-19 pandemic.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the proportion of participants who reported having an ACP discussion with his/her families at 3 months after enrollment.
Key secondary outcomes
The secondary outcomes included the following measures: scores on the four evaluation items of the Advance Care Planning Engagement Survey at 3 months, Advance Directive completion at 3 months, the determination of the surrogate decision-maker's role at 3 months, and the occurrence of post-intervention anxiety assessed in part using the GAD-7 scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
All study participants were provided with ACP leaflets supervised by the Ministry of Health, Labour and Welfare, which were handed out by collaborating researchers.
Interventions/Control_2
For the intervention group, an explanation regarding ACP introduction was conducted by collaborating researchers. The content of the intervention explanation followed a pre-established scenario, created in video format based on the Serious Illness Care Program (SICP) for reference. This scenario was shared in advance among collaborating researchers to ensure uniformity in the intervention method.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study participants consisted of Japanese outpatient patients aged 65 and older for whom informed consent had been obtained.
Key exclusion criteria
Individuals with dementia, severe hearing impairment, those for whom the attending physician clearly determined a prognosis of less than one month, and those who could not provide consent were excluded from the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | |
| Last name | Yoshihara Kurihara |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of General Medicine, Department of the Comprehensive Medicine 1
Zip code
330-8503
Address
1-847, Amanuma, Omiya, Saitama, Saitama, JAPAN
TEL
0486472111
chibihana.0701@gmail.com
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | |
| Last name | Yoshihara (Kurihara) |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of General Medicine, Department of the Comprehensive Medicine 1
Zip code
330-8503
Address
1-847, Amanuma, Omiya, Saitama, Saitama, JAPAN
TEL
0486472111
Homepage URL
chibihana.0701@gmail.com
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University, Division of General Medicine, Department of the Comprehensive Medicine 1, Hanako Yoshihara (Kurihara)
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Jichi Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Minamiuonuma City Hospital, Kyosai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical Center Clinical Research and Ethics Review Committee
Address
1-847, Amanuma, Omiya, Saitama, Saitama, JAPAN
Tel
0486472111
chibihana.0701@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
S21-133
Org. issuing International ID_1
Saitama Medical Center Clinical Research and Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
南魚沼市民病院（新潟県）、共済病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 10 | 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
49
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059781
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
