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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017222
Receipt No. 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 2020/04/24

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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
Email 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
Email hashizume.yumi.gu@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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