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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033516
Receipt No. R000038217
Scientific Title Effect of the management tool for daily life performance on patients with cardiovascular disease: A randomized controlled trial
Date of disclosure of the study information 2018/07/25
Last modified on 2018/07/25

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Basic information
Public title Effect of the management tool for daily life performance on patients with cardiovascular disease: A randomized controlled trial
Acronym Effect of the MTDLP on patients with cardiovascular disease
Scientific Title Effect of the management tool for daily life performance on patients with cardiovascular disease: A randomized controlled trial
Scientific Title:Acronym Effect of the MTDLP on patients with cardiovascular disease
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study aimed to examine the effectiveness of interventions using the management tool for daily life performance on patients with cardiovascular diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Self-rating depression scale after three months intervention
Key secondary outcomes Barthel index, Frenchay activities index, Life-Space Assessment

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention using the management tool for daily life performance in addition to normal Cardiac Rehabilitation for three months, once a week.
Interventions/Control_2 Normal cardiac rehabilitation.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with SDS score of 48 or more.
Key exclusion criteria Hospitalization that resulted from cardiac disease progression.
Discontinuation of their Cardiac Rehabilitation program.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Fukui
Organization Nara Prefectural Seiwa Medical Center
Division name Department of Rehabilitation
Zip code
Address 1-14-16, Mimuro, Sango-cho, Ikoma-gun, Nara, 636-0802, Japan
TEL 0745-32-0505
Email fukuimegumiot@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Fukui
Organization Nara Prefectural Seiwa Medical Center
Division name Department of Rehabilitation
Zip code
Address 1-14-16, Mimuro, Sango-cho, Ikoma-gun, Nara, 636-0802, Japan
TEL 0745-32-0505
Homepage URL
Email fukuimegumiot@gmail.com

Sponsor
Institute Nara Prefectural Seiwa Medical Center
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 奈良県西和医療センター(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 25 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 Completed
Date of protocol fixation
2017 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 30 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 05 Month 30 Day
Date trial data considered complete
2018 Year 05 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 25 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038217

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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