UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054893 |
|---|---|
| Receipt number | R000062722 |
| Scientific Title | Web-based Mindfulness and Self-Management Program for Pulmonary Hypertension |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2026/01/05 09:48:17 |
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Basic information
Public title
Mental and Physical Care Program Program for Pulmonary Hypertension Patients
Acronym
PH-mindfulness
Scientific Title
Web-based Mindfulness and Self-Management Program for Pulmonary Hypertension
Scientific Title:Acronym
PH-mindfulness
Region
| Japan |
Condition
Condition
Pulmonary Hypertension
Classification by specialty
| Cardiology | Pneumology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to implement and test the feasibility of a mindfulness-based mental and physical care program developed and revised for patients with pulmonary hypertension, and subsequently to expand the target population and test the effectiveness of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
emPHasis-10 (QOL scale for patients with pulmonary hypertension)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The online program will be conducted once a week and 6 times a week. The first, fourth, and sixth sessions are real-time online programs, so when the start time arrives, participants are asked to access the Zoom link from their smartphones, tablets, or PCs to enter the room and take the program. The 2nd, 3rd, and 5th sessions are on-demand, so participants access the website from their devices at their own pace at a time convenient to them and attend the program. Each session will last no longer than 60 minutes, considering the patient's level of fatigue, and will be held once a week for six sessions.
The program includes lectures and discussions on mindfulness and self-care in daily life, including side effects and activities. The program is conducted using a dedicated application.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following criteria
* Patients diagnosed with pulmonary hypertension and currently attending the Pulmonary Hypertension Outpatient Clinic at Kyorin University Hospital
* Between 20 and 75 years of age at the time of participation in the program
* Able to participate in all online real-time programs during the study period.
* Able to understand the purpose and content of the study and to obtain written consent to participate in the study of their own free will.
* Have access to an online environment at home and be able to attend the program for approximately 60 minutes each week.
* Able to operate the self-administration application on an iPhone or ipad
Key exclusion criteria
* Those who have serious physical symptoms (serious right heart failure) or mental symptoms (cognitive dysfunction, impaired consciousness, severe depression, etc.) and whose attending physician has determined that it is difficult for them to participate in the program.
* Those who have participated in the 8-week Mindfulness-Based Cognitive Therapy (MBCT) or Mindfulness-Based Stress Reduction (MBSR) program in the past.
* Those who cannot obtain permission from their attending physicians to participate in the study for reasons other than those listed above.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Takita |
Organization
Teikyo University
Division name
Faculty of Medical Technology, Department of Nursing
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
0339641211
takita.yuka.yw@teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Takita |
Organization
Teikyo University
Division name
Faculty of Medical Technology, Department of Nursing
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
0339641211
Homepage URL
takita.yuka.yw@teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
The 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
Teikyo University
Address
2-11-1, Kaga, Itbashi-ku, Tokyo, Japan
Tel
0339641211
turb-office@teikyo-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 | 09 | Month | 01 | 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
10
Results
Ten participants were enrolled; one withdrew before program initiation and one dropped out during the intervention, resulting in eight completers. Changes in primary outcome measures were observed pre- and post-intervention. Detailed analyses are ongoing, and results will be reported in future conference presentations and manuscripts.
Results date posted
| 2026 | Year | 01 | Month | 05 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062722
