UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033516 |
|---|---|
| Receipt number | 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 23:21:34 |
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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
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
fukuimegumiot@gmail.com
Sponsor or person
Institute
Nara Prefectural Seiwa Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038217
