UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062527 |
|---|---|
| Receipt number | R000062910 |
| Scientific Title | Evaluation of the Effectiveness and Feasibility of a Nurse-led General Advance Care Planning Booklet for Stroke Survivors at home |
| Date of disclosure of the study information | 2026/08/09 |
| Last modified on | 2026/08/09 17:11:55 |
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Basic information
Public title
Evaluation of the Effectiveness and Feasibility of a Nurse-led General Advance Care Planning Booklet for Stroke Survivors at home
Acronym
Evaluation of the Effectiveness and Feasibility of a Nurse-led General Advance Care Planning Booklet for Stroke Survivors at home
Scientific Title
Evaluation of the Effectiveness and Feasibility of a Nurse-led General Advance Care Planning Booklet for Stroke Survivors at home
Scientific Title:Acronym
Evaluation of the Effectiveness and Feasibility of a Nurse-led General Advance Care Planning Booklet for Stroke Survivors at home
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a Nursing Practice Model to Promote Advance Care Planning for Stroke Survivors at home,and to Evaluate the Effectiveness and Feasibility of a Nurse-led General Advance Care Planning Booklet for Stroke Survivors at home
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Readiness for Advance care planning
Key secondary outcomes
Communication between stroke survivors ans Nurses
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Home care nurses will provide support to stroke survivors using a ACP booklet based on the nursing practice model on three occasions during regular home care visits.A questionnaire survey will be administered to the stroke survivors before and after the intervention. After the intervention, interviews will be conducted with the subjects (stroke survivors and nurses who provided support) whose consent was obtained.
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses: 5-10 individuals meeting the following criteria
1 Working at a home-visit nursing station
2 At least three years of clinical experience as a nurse
3 Able to communicate in Japanese
Stroke Survivors: 10-20 individuals meeting the following criteria
1 Those who have been diagnosed with a stroke (with a history of cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage; the number of years since onset is not specified)
2 Utilizing home-visit nursing services
3 No apparent decline or loss of cognitive function
4 Able to communicate in Japanese
Key exclusion criteria
1 Apparent decline or loss of cognitive function
2 Inability to communicate in Japanese
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Usui |
Organization
Chiba University
Division name
Graduate school of Nursing
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-251-1111
s-usui@chiba-u.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Usui |
Organization
Chiba University
Division name
Gradate school of Nursing
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-251-1111
Homepage URL
s-usui@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Satoko Usui
Funding Source
Organization
Chiba 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
Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-251-1111
s-usui@chiba-u.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
| 2026 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
The protocol is not publicly available.
Publication of results
Unpublished
Result
URL related to results and publications
The results is not publicly available.
Number of participants that the trial has enrolled
14
Results
A total of 14 participants (six visiting nurses and eight stroke survivors) completed the study. RACP and ACPE scores improved significantly after the intervention (RACP: p = 0.04; ACPE: p = 0.02). Interviews revealed that stroke survivors used the practice guide to reflect on and document value sharing and the selection of a substitute decision-maker. Nurses assessed ACP feasibility in advance and used the guide to elicit patients' wishes and values.
Results date posted
| 2026 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
6 home-visit nurses,8 stroke survivors
Participant flow
Intervention providers: 6 home-visit nurses
Participants: 9 stroke survivors
Completed the intervention: 8
Withdrew or dropped out: 1
Included in the analysis: 8 stroke survivors
Adverse events
No adverse events were observed in this study.
Outcome measures
1.Readiness for Advance Care Planning (RACP) using the RACP scale
2.Engagement in Advance Care Planning (ACP) using the Advance Care Planning Engagement Survey (ACPE)
3.Perceptions of and perceived usefulness of the intervention, as assessed through semi-structured interviews following the intervention
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2025 | 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
| 2026 | Year | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062910
