UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058085 |
|---|---|
| Receipt number | R000066386 |
| Scientific Title | Advance Care Planning (ACP) from the Perspective of Patients with Amyotrophic Lateral Sclerosis: A Qualitative Analysis Using the Grounded Theory Approach |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/05 03:54:55 |
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Basic information
Public title
Advance Care Planning (ACP) from the Perspective of Patients with Amyotrophic Lateral Sclerosis: A Qualitative Analysis Using the Grounded Theory Approach
Acronym
Advance Care Planning (ACP) from the Perspective of Patients with Amyotrophic Lateral Sclerosis: A Qualitative Analysis Using the Grounded Theory Approach
Scientific Title
Advance Care Planning (ACP) from the Perspective of Patients with Amyotrophic Lateral Sclerosis: A Qualitative Analysis Using the Grounded Theory Approach
Scientific Title:Acronym
Advance Care Planning (ACP) from the Perspective of Patients with Amyotrophic Lateral Sclerosis: A Qualitative Analysis Using the Grounded Theory Approach
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the ACP process for ALS patients from their perspective, with a view to the point at which they become unable to express their wishes.
Basic objectives2
Others
Basic objectives -Others
Clarify the process through interview surveys.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discussions for when you are no longer able to express one's wishes
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ALS by an IC, those who the referrer determines can be interviewed through conversation or other means of communication, and those classified as severity levels 2 to 4 in the severity classification.
Key exclusion criteria
Those whom the referrer judges to be mentally or psychologically difficult to interview for about one hour, or those who have difficulty in communicating in Japanese.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Furuta |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Science Doctoral & Master' s Program in Nursing Science
Zip code
305-0005
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
0298590503
s2330463@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Furuta |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Science Doctoral & Master' s Program in Nursing Science
Zip code
3050005
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
09086818630
Homepage URL
s2330463@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Fumiko Yamaji Fund for Professional Nursing Education and Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
0298533914
rinshokenkyu@un.tsukuba.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
| 2025 | Year | 06 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 24 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 24 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Follow the interview guide and ask the following questions:
What to expect after being diagnosed with ALS
Discussions about what kind of life and medical care you would like to receive based on what is important to you and your life goals since diagnosis
What and with whom and when were these discussions held?
How you perceived your experience with ALS at that time
What did you think about your life after being diagnosed with ALS based on your knowledge of the disease?
Have you ever found it difficult to tell others about your disease? If so, who did you find it difficult to tell and why?
Were discussions ongoing and why were they ongoing?
What or who did you want to tell in preparation for the time when you are no longer able to express your feelings
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066386
