UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017222 |
|---|---|
| Receipt number | R000019975 |
| Scientific Title | The Coping with Oppressed Feeling Program: a pilot feasibility study for female employed caregivers of aged-parents |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2023/05/13 12:51:03 |
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Basic information
Public title
The Coping with Oppressed Feeling Program: a pilot feasibility study for female employed caregivers of aged-parents
Acronym
Coping with Oppressed Feelings Program
Scientific Title
The Coping with Oppressed Feeling Program: a pilot feasibility study for female employed caregivers of aged-parents
Scientific Title:Acronym
Coping with Oppressed Feelings Program
Region
| Japan |
Condition
Condition
Depressed mood
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the short-term outcomes of an educational counseling educational program for Japanese female working caregivers that was developed to reduce culturally sensitive distress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
CES-D
Key secondary outcomes
J-ZBI, time for self-care activity, self-report on appraisal of the amount of conversation and feeling of acceptance by the spouse.
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
1. Pre test, a booklet, completed structured writing assignment for 25 minutes a day for 4 days, two homeworks, 2. Behavioral tip sheet on self care, instructed to choose a specific activity from the list or pick up any habit one had been involved, and were encouraged to engage in it for 2 weeks, 3. Evaluation of session 2. Encouraged to continue it for another three weeks, 4.Spouses participation was requested. Two study materials for the spouse and self administered survey sheet for assessing on task sharing and emotional support for his wife, 5.Post test and evaluation of the whole intervention sessions
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Female, married employed caregivers in certain profession, aged 40s to 60s. (2)Spouse are also employed or retired, aged 40s to 70s.
Key exclusion criteria
(1)Unemployed caregivers, (2)care-recipient are not the elderly parent/ parent-in-law
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Hashizume |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8577, Japan
TEL
+81-29-853-1040
hashizume.yumi.gu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hashizume |
Organization
Faculty of Medicine
Division name
Gerontological Nursing and caring
Zip code
305-8577
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8577, Japan
TEL
+81-29-853-3986
Homepage URL
hashizume.yumi.gu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Meijiyasuda Mental Health Foundation
IRB Contact (For public release)
Organization
University of Tsukuba
Address
Tennoudai 1-1-1 Tsukuba, Ibaraki
Tel
+81-29-853-1040
hashizume.yumi.gu@u.tsukuba.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
勤労女性介護者のいる施設・機関
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://scholarlypages.org/Articles/nursing/jnp-2-010.php?jid=nursing
Number of participants that the trial has enrolled
Results
The Journal of Nutrition, Health and Aging, 17, Supplement 1, 2013, s680.
Journal of Nursing & Practice, 2(2),62-72, 2018
Results date posted
| 2020 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 08 | Month | 01 | Day |
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
| 2010 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 02 | Month | 21 | Day |
Other
Other related information
A part of study result has been published partially in 2018.
Management information
Registered date
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019975
| Research Plan | |
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| 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 |
