UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037130 |
|---|---|
| Receipt number | R000042273 |
| Scientific Title | The effectiveness of a support program for family caregiver in home-based palliative care: a randomized controlled trial |
| Date of disclosure of the study information | 2019/06/21 |
| Last modified on | 2022/06/28 09:37:05 |
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Basic information
Public title
The effectiveness of a support program for family caregiver in home-based palliative care: a randomized controlled trial
Acronym
The effectiveness of a support program for family caregiver in home-based palliative care-a RCT
Scientific Title
The effectiveness of a support program for family caregiver in home-based palliative care: a randomized controlled trial
Scientific Title:Acronym
The effectiveness of a support program for family caregiver in home-based palliative care-a RCT
Region
| Japan |
Condition
Condition
Advanced and/or terminally ill cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the online daily diary program using for family caregiver in home-based palliative care,and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Family caregiver's QOL
Key secondary outcomes
Depression
Satisfaction of home care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Group
Daily Diary Method
Health education about caregiving experiences
Written online diary once a day for 1 weeks
Interventions/Control_2
Control Group
Usual care
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
Family caregivers of advanced cancer patients in home based palliative care
Advanced cancer patients are diagnosed as advanced cancer by primary doctor, with life expectancy of less 6 months, and age of 20 year old or older
1.unpaid caregivers such as family members, partners, and relatives who take care of their loved ones
2.age of 20 years old or older
Key exclusion criteria
1.age of under 20 years
2.being unable to participate in the survey
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Community Health Nursing
Zip code
2360004
Address
3-9,Fukuura,Kanazawa-ku,Yokohama,236-0004 Japan
TEL
0457872973
eriko_m@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Community Health Nursing
Zip code
2360004
Address
3-9,Fukuura,Kanazawa-ku,Yokohama,236-0004 Japan
TEL
0457872973
Homepage URL
eriko_m@yokohama-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of the Medical Department of Yokohama City University
Address
3-9,Fukuura,Kanazawa-ku,Yokohama,236-0004 Japan
Tel
0453707629
nextjim1@yokohama-cu.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
| 2019 | Year | 06 | Month | 21 | 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
105
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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 05 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042273
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
