UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045049 |
|---|---|
| Receipt number | R000051449 |
| Scientific Title | Supports for reducing parenting stress among caregivers of children with allergies and its effects: A randomized controlled trial |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/08/10 13:11:14 |
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Basic information
Public title
Supports for reducing parenting stress among caregivers of children with allergies and its effects: A randomized controlled trial
Acronym
Supports for reducing parenting stress among caregivers of children with allergies and its effects: A randomized controlled trial
Scientific Title
Supports for reducing parenting stress among caregivers of children with allergies and its effects: A randomized controlled trial
Scientific Title:Acronym
Supports for reducing parenting stress among caregivers of children with allergies and its effects: A randomized controlled trial
Region
| Japan |
Condition
Condition
Allergy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a randomized controlled trial in which the primary caregivers of children with allergies were randomly divided into a group that was given allergy-related support and a placebo group and to examine the effectiveness of that support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the difference in Parenting Stress Index (PSI) scores between the intervention(Z1) and placebo(Z0) groups at the beginning of the study and after the intervention.
Key secondary outcomes
Per-protocol/as-treated analysis with intervention group (A1) and placebo group (A0) reconstructed from compliance information of intervention and placebo groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will receive allergy-related online support and links to existing allergy information once a week.
Participants will complete questionnaires sent via online at the start, after 4 weeks, after 8 weeks, and after 12 weeks.
Interventions/Control_2
The placebo group will only receive a link to existing allergy information once a week.
Participants will complete questionnaires sent via online at the start, after 4 weeks, after 8 weeks, and after 12 weeks.
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
| 2 | years-old | <= |
Age-upper limit
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The primary caregiver of a child who has been diagnosed with one or more of the following allergic diseases (atopic dermatitis, allergic bronchial asthma, allergic rhinitis, food allergy) and is currently undergoing treatment.
(2) The child is between 2 and 4 years old and is not enrolled in kindergarten.
(3) Written consent for participation in this study has been obtained from the research participant.
Key exclusion criteria
(1) The child has chronic disease other than allergy.
(2) The primary caregiver is pregnant or may be pregnant.
(3) The primary caregiver plans to return to work and enroll the child in kindergarten during the intervention period of the study.
(4) The participant does not use a smartphone.
(5) Other cases in which the research participant is inappropriate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chikae |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kinjo Gakuin University
Division name
Department of Nursing, Faculty of Nursing
Zip code
463-8521
Address
2-1723 Omori, Moriyama-ku, Nogoya, Aichi 463-8521 JAPAN
TEL
052-798-0180
yamaguchi@kinjo-u.ac.jp
Public contact
Name of contact person
| 1st name | Chikae |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kinjo Gakuin University
Division name
Department of Nursing, Faculty of Nursing
Zip code
463-8521
Address
2-1723 Omori, Moriyama-ku, Nogoya, Aichi 463-8521 JAPAN
TEL
052-798-0180
Homepage URL
yamaguchi@kinjo-u.ac.jp
Sponsor or person
Institute
Kinjo Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Clinical Research Management center, Nagoya City University Hospital
Address
Mizuho-cho,Mizuho-ku Nagoya 467-8601,Japan
Tel
0528538348
clinical_research@med.nagoya-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
| 2021 | Year | 09 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2021 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051449
