UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the management tool for daily life performance on patients with cardiovascular disease: A randomized controlled trial
Title of the study (Brief title)	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	Megumi Fukui
Organization	Nara Prefectural Seiwa Medical Center
Division name	Department of Rehabilitation
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	Megumi Fukui
Organization	Nara Prefectural Seiwa Medical Center
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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