UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054571 |
|---|---|
| Receipt number | R000062296 |
| Scientific Title | Effect verification of intervention using Management Tool for Daily Life Performance for patients with heart disease in rehabilitation hospitals. |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2024/06/05 08:53:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect verification of occupational therapy for patients with heart disease
Acronym
Occupational therapy for patients with heart disease
Scientific Title
Effect verification of intervention using Management Tool for Daily Life Performance for patients with heart disease in rehabilitation hospitals.
Scientific Title:Acronym
Effect verification of intervention using Management Tool for Daily Life Performance for patients with heart disease
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether Activities of daily living improve by adding an intervention using Management Tool for Daily Life Performance to conventional cardiac rehabilitation for patients with heart disease hospitalized in rehabilitation hospitals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional independence measure
Key secondary outcomes
1. Barthel Index
2. Frenchay activity index index
3. Hand grip strength
4. Short Physical Performance Battery (SPPB)
5. EuroQOL-5
6. Hospital anxiety and depression scale
7. Interdependent Happiness Scale Scale
8. Satisfaction With Life Scale Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Within one week of starting the intervention, the Aid for Decision-making in Occupation Choice 2 (ADOC2) was used to set agreed-upon goals and create a daily living activity management sheet. Subsequently, the intervention was carried out in accordance with the daily living activity management sheet, in addition to exercise therapy and heart failure education.
The intervention was only conducted during hospitalization. The number of sessions varied depending on the length of hospitalization.
Interventions/Control_2
Exercise therapy and heart failure guidance based on guidelines that consider heart function, blood pressure, etc.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with heart failure
2. Able to communicate
3. Obtained informed consent for participation in the study
Key exclusion criteria
1. Individuals who cannot provide informed consent
2. Individuals with severe cognitive impairment, aphasia, or mental illness that makes communication difficult
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takeda |
Organization
Niigata Minami Hospital
Division name
Department of Rehabilitation
Zip code
950-8601
Address
2007-6, Toyano, Chuo-ku, Niigata, Niigata, Japan
TEL
025-284-2511
tonsuke.tomo2@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Takeda |
Organization
Niigata Minami Hospital
Division name
Department of Rehabilitation
Zip code
950-8601
Address
2007-6, Toyano, Chuo-ku, Niigata, Niigata, Japan
TEL
025-284-2511
Homepage URL
tonsuke.tomo2@gmail.com
Sponsor or person
Institute
Niigata Minami HOspital, Department of Rehabilitation, Tomonori Takeda
Institute
Department
Personal name
Tomonori Takeda
Funding Source
Organization
Japanese Association of Occupational Therapists
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
Ethics Committee of Niigata University
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata
Tel
025-227-2625
tonsuke.tomo2@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2306
Org. issuing International ID_1
Niigata Minami Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062296
