UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051985 |
|---|---|
| Receipt number | R000059269 |
| Scientific Title | Research Study on Patients' Health Management Attitudes and Behaviors through the Use of the Kakalink Toranomon Application to Support Self-Management after Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2024/04/15 09:25:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research Study on Patients' Health Management Attitudes and Behaviors through the Use of the Kakalink Toranomon Application to Support Self-Management after Hematopoietic Stem Cell Transplantation
Acronym
Research Study on Patients' Health Management Attitudes and Behaviors through the Use of the Kakalink Toranomon Application to Support Self-Management after Hematopoietic Stem Cell Transplantation
Scientific Title
Research Study on Patients' Health Management Attitudes and Behaviors through the Use of the Kakalink Toranomon Application to Support Self-Management after Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
Research Study on Patients' Health Management Attitudes and Behaviors through the Use of the Kakalink Toranomon Application to Support Self-Management after Hematopoietic Stem Cell Transplantation
Region
| Japan |
Condition
Condition
Patients undergoing hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To optimize the long-term support system for patients after HSCT by surveying HSCT patients' health management awareness (health awareness), ascertaining whether effective use of the application through intervention by healthcare providers can raise health awareness and contribute to lifelong long-term follow-up measures, and clarifying related factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health Attitude Change and Behavior of Application-Using Patients Due to Intervention by Medical Professionals.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The attending physician, nurse in charge of post-transplant nursing outpatient clinic, LTFU physician and transplant coordinator will intervene in the intervention group at least once a week during outpatient visits and using the reply function of the application. The use of the application will be checked at the attending physician's outpatient clinic, etc., and information on daily vital signs, physical condition, weight measurements, etc. will be shared with the medical staff. In addition, during LTFU outpatient visits and post-transplant nursing outpatient visits, positive feedback on the support provided during outpatient visits should be shared with the patient using the notification function. The timing of intervention by medical staff is scheduled and controlled to avoid missing interventions. In addition, twice a month, the hematology department and the Long-term Follow-up Center for Hematopoietic Cell Transplantation send newsletters according to the current situation.
Interventions/Control_2
The non-intervention group will not be asked to confirm information entered into the application by the healthcare provider, but information will be shared when presented by the patient. The GVHD interview function and quality of life survey used as medical care during LTFU outpatient and post-transplant nursing outpatient visits will be used only during those outpatient visits. No positive feedback or newsletters will be sent out using the notification function regarding what was assisted in the outpatient setting.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are 20 years of age or older and give written consent, can read the questionnaire written in Japanese, and plan to install the "Kakalink Toranomon App".
Key exclusion criteria
Patients scheduled for readmission
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Uchida |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
nuchida@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Narita |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
toraco@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Toranomon Hospital
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2023 | Year | 08 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059269
