UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022167 |
|---|---|
| Receipt number | R000025542 |
| Scientific Title | Qualitative study to make use of the narrative of patients with neurological intractable diseases and their families for better medical care |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2022/11/10 14:18:41 |
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Basic information
Public title
Qualitative study to make use of the narrative of patients with neurological intractable diseases and their families for better medical care
Acronym
Qualitative study on narrative of patients
Scientific Title
Qualitative study to make use of the narrative of patients with neurological intractable diseases and their families for better medical care
Scientific Title:Acronym
Qualitative study on narrative of patients
Region
| Japan | Asia(except Japan) |
Condition
Condition
Neurological intractable diseases
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We aim to clarify the life actual situation of the patients with neurological intractable diseases and their family and get information for future medical support.
Basic objectives2
Others
Basic objectives -Others
We clarify physical and mental state of patients with neurological intractable diseases and their family and find better directions for the establishment of medical treatment guidelines.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The problems that the patients with the neurological intractable diseases and their families have in their minds become more clear than before.
Key secondary outcomes
The specificity of each neurological intractable disease becomes clear by comparing it among the other neurologic intractable diseases.
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
It is based on the diagnostic criteria of each disease.
# Idiopathic basal ganglia calcification (IBGC)
# Amyotrophic lateral sclerosis (ALS)
# Other rare neurological intractable diseases
Key exclusion criteria
For IBGC, we exclude diseases which show calcification, because of some causes such as hypoparathyroism, pseudohypoparathyroism, pseudopseudohypoparathyroism (Albright' s osteodystrophy), Down syndrome, collagen diseases, angiitis, infections, intoxication, trauma, radiation therapy and so on.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Hozumi |
Organization
Gifu Pharmaceutical University
Division name
Laboratory of Medical Therapeutics and Molecular Therapeutics
Zip code
501-1196
Address
1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
TEL
058-230-8121
hozumi@gifu-pu.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Hozumi |
Organization
Gifu Pharmaceutical University
Division name
Laboratory of Medical Therapeutics and Molecular Therapeutics
Zip code
501-1196
Address
1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
TEL
058-230-8121
Homepage URL
hozumi@gifu-pu.ac.jp
Sponsor or person
Institute
Gifu Pharmaceutical University
Laboratory of Medical Therapeutics and Molecular Therapeutics
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Gifu University
Toyama Prefectural University
Name of secondary funder(s)
Japan Agency for Medical Research and Development
IRB Contact (For public release)
Organization
Ethics Committee of Gifu Pharmaceutical University
Address
1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
Tel
058-230-8100
syomuk@gifu-pu.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
岐阜薬科大学 Gifu Pharmaceutical University
岐阜大学 Gifu University
富山県立大学 Toyama Prefectural University
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://springerplus.springeropen.com/articles/10.1186/s40064-016-3390-z
Publication of results
Partially published
Result
URL related to results and publications
https://springerplus.springeropen.com/articles/10.1186/s40064-016-3390-z
Number of participants that the trial has enrolled
Results
We made clear wrong recognition of the patients and their families due to lack of information on the diseases, uneasiness and agony accompanied with the progress of the diseases, and altered consciousness led by suffering from the disease. In addition, the questions for the experts and the requests for the medical system became clear. We also recognized the need for the adequate genetic counseling system and the psychological support again.
Results date posted
| 2019 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
IBGC patients and their families
ALS patients and their families
Other neurological intractable diseases patients and their families
Participant flow
Patients (IBGC or ALS or other neurological intractable diseases) or their families are interviewed.
Interviews are performed in a quiet, closed room in a hospital or hotel, with no other person present.
Interviews are face to face and performed by a professional interviewer who first introduced herself and obtained written informed consent.
Each interview is recorded with a digital voice recorder. The protection of participants' privacy is paramount. The interviewer encourages participants to speak about their experiences as freely as possible.
All statements made by participants in the interviews are recorded and fully transcribed. The credibility and transferability of interview texts were checked by two researchers. The transcribed texts are analyzed using qualitative data analysis software, MAXQDA10 (VERBI Software, Berlin, Germany).
Adverse events
All participants can always refuse to join this research without disadvantage for them or their families even after their agreement.
Outcome measures
All statements made by participants in the interviews are recorded and fully transcribed. The credibility and transferability of interview texts were checked by two researchers. The transcribed texts are analyzed using qualitative data analysis software, MAXQDA10 (VERBI Software, Berlin, Germany).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Study design (qualitative narrative study), the subjects of the study: the patients who are compatible with the criteria of each disease and their families in Gifu University Hospital or Toyama University Hospital) since December 2012. Among them, the persons from whom we have obtained the informed consent.
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025542
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/11/12 | 語り研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/11/12 | s40064-016-3390-z.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/11/12 | s40064-016-3390-z.pdf |
