UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051691 |
|---|---|
| Receipt number | R000058777 |
| Scientific Title | Self-care Support Using ICT for Patients after Percutaneous Coronary Intervention in the Maintenance Phase of Cardiac Rehabilitation: Case-based Evaluation |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/02/23 15:09:36 |
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Basic information
Public title
Self-care Support Using ICT for Patients after Percutaneous Coronary Intervention in the Maintenance Phase of Cardiac Rehabilitation
Acronym
Self-care Support Using ICT for Patients after Percutaneous Coronary Intervention
Scientific Title
Self-care Support Using ICT for Patients after Percutaneous Coronary Intervention in the Maintenance Phase of Cardiac Rehabilitation: Case-based Evaluation
Scientific Title:Acronym
Self-care Support Using ICT for Patients after Percutaneous Coronary Intervention in the Maintenance Phase of Cardiac Rehabilitation
Region
| Japan |
Condition
Condition
Patients after percutaneous coronary intervention in the maintenance phase of cardiac rehabilitation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate a self-care support program using ICT for post-PCI patients during the maintenance period of cardiac rehabilitation through case studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-Care Agency Questionnaire: SCAQ (Honjo, 2015)
Evaluate before intervention and at third month of intervention.
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention will be based on the procedures of "Nursing Support Program for Enhancing Self-Care Skills of People with Chronic Illness (Honjo,2015)". The Support is provided using ICT to assess strengths and weaknesses in self-care and to think together with patients about specific self-care strategies through dialogue.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient attending an outpatient cardiology clinic in Hyogo, who are at least 6 months post-PCI, and have and can operate ICT equipment for interaction
Key exclusion criteria
Patients whose participation in the research is judged by the physician to be physically or mentally burdensome.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Hatamochi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing
Zip code
5838555
Address
3-7-30 Habikino, Habikino City, Osaka, Japan
TEL
+81-072-950-2784
chiekos@omu.ac.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Hatamochi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka, Japan
TEL
+81-072-950-2784
Homepage URL
chiekos@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Nursing
Address
3-7-30 Habikino, Habikino City, Osaka, Japan
Tel
072-950-2134
gr-hab-rinri@omu.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
| 2023 | Year | 08 | Month | 01 | 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
6
Results
The subjects were 4 males and 2 females and ICT utilization was 4 video calls and 2 telephone calls. Based on the SCAQ-30 assessment, tasks and goals were set with the subjects, and support was provided through self-directed learning and partnership while assessing strengths. After the intervension, SCAQ scores increased by 1 to 9 points. No worsening of blood data or symptoms was observed.
Results date posted
| 2024 | Year | 02 | Month | 23 | Day |
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
| 2023 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
