UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044172
Receipt number R000050422
Scientific Title Family Empowerment Programs for Caregivers of Children with Disabilities at Home
Date of disclosure of the study information 2021/05/19
Last modified on 2022/11/11 09:24:16

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Basic information

Public title

Family Empowerment Programs for Caregivers of Children with Disabilities at Home

Acronym

Family Empowerment Programs for Caregivers of Children with Disabilities at Home

Scientific Title

Family Empowerment Programs for Caregivers of Children with Disabilities at Home

Scientific Title:Acronym

Family Empowerment Programs for Caregivers of Children with Disabilities at Home

Region

Japan


Condition

Condition

Caregivers rearing the children with disabilities

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will examine whether a family empowerment program for caregivers who raise children with disabilities at home has the effect of reducing the burden on them, promoting the utilization of social resources, increasing self-compassion, and increasing family empowerment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

family empowerment

Key secondary outcomes

Care burden
Self-compassion
Awareness of the utilization of social resources
QOL of the main caregiver


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are 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 Other

Interventions/Control_1

Intervention group(Intervention period is 4 weeks)
1st week
1) Explain the outline of Family Empowerment
2) Through the creation and sharing of eco-maps, raise awareness of the three levels of Family Empowerment (FA / SS / SP)
2nd week
1) Encourage preparation for using Family Empowerment(Part1)
2) Review and share the week's life with each other
3) Have an opportunity to think about issues in your current life and your desired life
3) Ask participants to look back on the current situation of their children and their families
3rd week
1) Encourage preparation for using Family Empowerment(Part2)
2) Set specific goals for their desired life
3) Have participants share the goals set in 2)
4th week
1) Encourage the use of Family Empowerment
2) Presenting how it was to act toward a specific goal for the desired life, focusing on "concrete changes in life" and "self-evaluation", and praise and comments from other participants
The control group waits for the intervention period of the intervention group.

Interventions/Control_2

The waiting control group will be given the same intervention as the intervention group for 4 weeks.During this period, the intervention group does nothing.

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

Caregivers raising children with disabilities at home

Key exclusion criteria

Those who do not have internet environment and device, Those who cannot read and write Japanese

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Rie
Middle name
Last name Wakimizu

Organization

University of Tsukuba

Division name

Division of Health Innovation and Nursing, Faculty of Medicine

Zip code

305-8575

Address

1-1-1, Tennodai, Tsukuba-city

TEL

029-853-3427

Email

riewaki@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Wakimizu

Organization

University of Tsukuba

Division name

Division of Health Innovation and Nursing, Faculty of Medicine

Zip code

305-8575

Address

1-1-1, Tennodai, Tsukuba-city

TEL

029-853-3427

Homepage URL

https://shouni-kazoku.jp/update/research/55

Email

riewaki@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba
Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

the Grant-in-Aid for Scientific Research (B) from the Ministry of Education, Culture, Sports, Science, and Technology, Japan (18H03093)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba

Address

1-1-1, Tennodai, Tsukuba-city

Tel

0298533427

Email

riewaki@md.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



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 19 Day


Related information

URL releasing protocol

https://doi.org/10.21203/rs.3.rs-998023/v1

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

60

Results

The primary outcome, family empowerment, measured using the Family Empowerment Scale (FES), was significantly higher at T2 for the intervention group than the waitlist-controlled group and was sustained in the sensitivity analysis.
The developed intervention program promotes family empowerment in families of children with disabilities.

Results date posted

2022 Year 05 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Participants were family caregivers of children with physical, intellectual, or developmental disabilities living at home. The type of disability was not limited. Participants who could not read or write in Japanese or connect to the Internet were excluded.

Participant flow

In total, 20,000 leaflets explaining the study and requesting cooperation were sent via post to authorities of organizations catering to CWD, such as specialized medical institutions and rehabilitation centers for children with physical disabilities, university hospitals, specialist pediatric hospitals, medical welfare departments of local governments, and special-needs schools for children with physical impairment or chronic diseases.
Interested authorities displayed the program handouts within their facilities and distributed them among people fitting the inclusion criteria and explained the study to them. These handouts contained the general outline and schedule of the program, its target participants, and intended implementation method. Interested participants could then access a dedicated website using the handout information to apply to the program, thus consenting to participation.

Adverse events

None.

Outcome measures

The main outcome, family empowerment, was measured using the Japanese version of the Family Empowerment Scale (FES).
The secondary outcomes were caregiver burden, awareness of using social resources, self-compassion, and the QOL of primary caregivers. Caregiver burden was measured at using the short form of the Japanese version of the Zarit Caregiver Burden Interview (J-ZBI-8).

Plan to share IPD

None.

IPD sharing Plan description

None.


Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 08 Month 22 Day

Date of IRB

2019 Year 08 Month 22 Day

Anticipated trial start date

2021 Year 04 Month 03 Day

Last follow-up date

2021 Year 12 Month 27 Day

Date of closure to data entry

2022 Year 01 Month 31 Day

Date trial data considered complete

2022 Year 02 Month 28 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information

Wakimizu R, Matsuzawa A, Fujioka H,
Nishigaki K, Sato I, Suzuki S and Iwata N (2022)
Effectiveness of a peer group-based online
intervention program in empowering families of
children with disabilities at home.
Front. Pediatr. 10:929146.
doi: 10.3389/fped.2022.929146


Management information

Registered date

2021 Year 05 Month 11 Day

Last modified on

2022 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050422


Research Plan
Registered date File name

Research case data specifications
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Research case data
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