UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044075 |
|---|---|
| Receipt number | R000050319 |
| Scientific Title | Development and feasibility study of a Mindfulness Based Self-Management Program for Pulmonary Hypertension. |
| Date of disclosure of the study information | 2021/04/28 |
| Last modified on | 2023/02/14 18:20:44 |
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Basic information
Public title
Development and feasibility study of a Mindfulness Based Self-Management Program for Pulmonary Hypertension.
Acronym
MBSeMa for PH
Scientific Title
Development and feasibility study of a Mindfulness Based Self-Management Program for Pulmonary Hypertension.
Scientific Title:Acronym
MBSeMa for PH
Region
| Japan |
Condition
Condition
Pulmonary Hypertension
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement and evaluate the developed programme to verify its feasibility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
/ Changes in PHQ-9 and GAD-7 before and after 4 weeks of the program, and after the completion of the entire program
Key secondary outcomes
/ Program participation rate
/ Homework implementation rate
/CD-RISC
/emPHasis-10(QOL scaleforPH)
/Lonlines scale
/Interview about awareness of self-management
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eight weekly sessions by mindfulness-based self-management programme for patients with pulmonary hypertension
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
/Patient diagnosed with pulmonary hypertension and received treatment at clinic
/Ability to participate the program at least 6 mindfulness program
/Ability to consent in writing
/Online access at home
/Ability to use self-management apps on iPhone or iPad
Key exclusion criteria
/ Serious physical symptoms (severe right heart failure)
/`Psychiatric symptoms (cognitive impairment, disorientation, severe depression, etc.)
/Patient who previously attended an 8-week Mindfulness-Based Cognitive Therapy (MBCT) or Mindfulness-Based Stress Reduction (MBSR) programme.
/Those who are unable to obtain permission from their doctor to participate in the study for reasons other than those listed above.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Takita |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama-shi, Saitama
TEL
+81429556956
takita-y@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Takita |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama-shi, Saitama
TEL
+81429556956
Homepage URL
takita-y@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyorin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Kasei University
Address
Tokyo Kasei University
Tel
+81429521621
kanuma-y@tokyo-kasei.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
| 2021 | Year | 04 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
