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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044075
Receipt No. 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 2021/04/28

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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
Email 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
Email takita-y@tokyo-kasei.ac.jp

Sponsor
Institute Tokyo Kasei University
Institute
Department

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
Email 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 Enrolling by invitation
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
2022 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
2021 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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