UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048425 |
|---|---|
| Receipt number | R000055189 |
| Scientific Title | A randomized controlled trial to study effectiveness of peer support on family taking care of eating disorder patients |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/09/03 20:07:10 |
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Basic information
Public title
A study of peer support for family taking care of eating disorder patients
Acronym
ED family peer study
Scientific Title
A randomized controlled trial to study effectiveness of peer support on family taking care of eating disorder patients
Scientific Title:Acronym
ED family peer support RCT study
Region
| Japan |
Condition
Condition
Eating disorders
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study of effectiveness of consultation of peer supporters (trained by our program) on mood and burden feeling of family taking care of eating disorder patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mood change estimated by the Japanese edition of Profile of Mood States 2nd Edition (POMS2)
Key secondary outcomes
Care burden feeling estimated by the short version of Japanese version of the Zarit caregiver burden questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Subjects who take inventory survey just before and within two weeks after consultation by peer supporters
Interventions/Control_2
Control group: Subjects who take inventory survey on entry of the waiting list and just before consultation by peer supporters
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person who is over 18 years old, a father or a mother who has experience of taking care of eating disorder patients and signed written consent of this study
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Suzuki |
Organization
Atomi University
Division name
Faculty of Psychology, Department of Clinical Psychology
Zip code
352-8501
Address
1-9-6 Nakano, Niiza-shi, Saitama 352-8501 Japan
TEL
048-478-3333
m-suzuki@atomi.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Suzuki |
Organization
Atomi University
Division name
Faculty of Psychology, Department of Clinical Psychology
Zip code
352-8501
Address
1-9-6 Nakano, Niiza-shi, Saitama 352-8501 Japan
TEL
048-478-3333
Homepage URL
https://select-type.com/ev/?ev=sQa8kYYnkUA&eventPageID=
m-suzuki@atomi.ac.jp
Sponsor or person
Institute
Atomi University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Jao
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Atomi University
Address
1-9-6 Nakano, Niiza-shi, Saitama 352-8501 Japan
Tel
048-478-3333
d-shomu@atomi.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
跡見学園女子大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
79
Results
We performed a randomized controlled trial comparing consultations with family peer supporters (intervention group) with waiting before a meeting (control group). We found no significant difference in changes in POMS2 TMD scores between both groups. Multiple regression analysis using whole data showed that the changes in consultees'POMS2 TMD scores were predicted by the POMS2 TMD score before the consultation, the urrent BMI of the patient, and the score of the General Self-Efficacy Scale.
Results date posted
| 2024 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Group Intervention (n=36) Control (n=32)
Appanage Father/Mother 1/35 1/31
Age 40s 7 13
50s 26 13
60s 3 5
70s 0 1
Living together with a patient 28 28
apart from a patient 8 4
Patient age(years)
Mean,SD 20.7,4.8 19.5,5.7
Minimum/Maximum 13/38 12/39
Type of illness at the present
Anorexia nervosa Restrictig:11 Restrictig:17
Binge eating/purging:9 Binge eating/purging:4
Bulimia nervosa 11 8
Binge eating disorder 5 2
Not identified 0 1
The lowest BMI during illness (kg/m2)
Mean, SD 14.0, 2.4 13.8, 2.3
Minimum/Maximum 9.3/19.0 9.5/19.7
BMI at the present (kg/m2)
Mean, SD 17.6, 3.9 17.3, 3.5
Minimum/Maximum 10.1/27.0 12.3/29.3
Condition at the present
the worst 9 7
improved a little 14 15
considerably improved 9 9
completely recovered 0 0
not determined 4 1
The past history of hospitalization 18 22
The past history of emergency care 5 5
Participant flow
A total of 79 participants were recruited and randomized into the meeting intervention (n = 40) and control (n = 39) groups. Two members of the intervention group were absent from the consultation and two failed to answer the questionnaire. Three members of the control group were absent from the consultation, two did not return the questionnaire, and two failed to answer the questionnaire. Finally, we were able to analyze 36 members of the intervention group and 32 of the control group.
Adverse events
No adverse events occurred, such as mood contagion, negative interactions, a dangerous atmosphere, emotional outbursts, worsened psychological health, or leaving midway through the consultation among peer supporters and consultees.
Outcome measures
The primary outcome was the level of the negative mood as estimated by POMS-2 TMD scores, and the secondary outcome was the caregiver burden as estimated by J-ZBI_8 scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055189
