UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054710 |
|---|---|
| Receipt number | R000062521 |
| Scientific Title | Research on development and validation of a hope scale for chronic diseases |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2024/06/19 16:40:09 |
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Basic information
Public title
Study of hope scale for chronic diseases
Acronym
Hope Study
Scientific Title
Research on development and validation of a hope scale for chronic diseases
Scientific Title:Acronym
Hope Study
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between hope and health-related quality of life.
Basic objectives2
Others
Basic objectives -Others
To examine the predictors of hope
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related quality of life
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non-dialysis chronic kidney disease, or patients undergoing hemodialysis therapy, or peritoneal dialysis therapy
Key exclusion criteria
Patients who have difficulty in communicating, patients with active, advanced cancer
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Kurita |
Organization
Fukushima Medical University Hospital
Division name
Department of Innovative Research and Education for Clinicians and Trainees
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
0245471470
kuritan@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Kurita |
Organization
Fukushima Medical University Hospital
Division name
Department of Innovative Research and Education for Clinicians and Trainees
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1470
Homepage URL
kuritan@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, St. Marianna University School of Medicine
Address
2-16-1 Sugo, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2024 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/ace/1/3/1_No.19-15/_html/-char/ja
Publication of results
Partially published
Result
URL related to results and publications
https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-020-02120-0
Number of participants that the trial has enrolled
454
Results
Using observational research approach, we were able to analyze the factors associated with hope. We also demonstrated that hope was associated with health-related quality of life.
Results date posted
| 2024 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As reported in the literature, the mean age was 67.4 years, 32% were women, 126 patients had nondialysis chronic kidney disease, 105 patients underwent peritoneal dialysis, and 223 patients underwent hemodialysis.
Participant flow
At baseline, 454 participants responded to the survey; 295 and 203 participants responded at one and two year follow-up, respectively.
Adverse events
Since this was an observational study using a self-administered questionnaire, there were no adverse events.
Outcome measures
Hope scores were revealed to differ according to the severity of kidney disease.
Higher levels of hope scores were associated with higher levels of health-related quality of life.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using observational research approach, we were able to analyze the factors associated with hope. We also demonstrated that hope was associated with health-related quality of life.
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062521
