UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049167 |
|---|---|
| Receipt number | R000056005 |
| Scientific Title | Development of Psycho-social Support Program for Patients and Caregivers of Myotonic Dystrophy Type 1 |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2024/04/19 15:04:18 |
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Basic information
Public title
Development of Psycho-social Support Program for Patients and Caregivers of Myotonic Dystrophy Type 1
Acronym
DM Psycho-social Support Study
Scientific Title
Development of Psycho-social Support Program for Patients and Caregivers of Myotonic Dystrophy Type 1
Scientific Title:Acronym
DM Psycho-social Support Study
Region
| Japan |
Condition
Condition
Myotonic dystrophy type 1
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Myotonic dystrophy type 1 (DM1) is a rare disease with autosomal dominant inheritance with a relatively common occurrence among muscular dystrophies. Its symptoms are diverse and include muscle weakness, myotonia, gastrointestinal and cardiopulmonary symptoms, dysphagia, problems in vision and hearing, endocrine symptoms, cognitive dysfunction including apathy, pain, daytime sleepiness and fatigue. For this reason, in order to improve the patient's life prognosis and QOL a multidisciplinary approach involving medical care, physiotherapy, diet therapy, rehabilitation and psycho-social support is necessary in DM1 care. However, due to the strong impact from the severity of physical symptoms, psycho-social aspect of care is often overlooked. We conducted a preliminary survey on QOL of the patients and caregiver burden (Endo et al., 2019; Kurauchi et al., 2019). Based on the results, we developed a psycho-social support program which aims to improve patient's felt symptoms and caregiver's caregiving burden through increasing activity of the patient by utilizing occupational therapy approach and through psychoeducation of self-care. This study is a single-group interventional study to examine the effects of the program.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity and Participation: Frenchay Activities Index
Key secondary outcomes
Fatigue: Fatigue Severity Scale
Daytime Sleepiness: Epworth Sleepiness Scale
QOL: SF-12v2
Apathy: Apathy Evaluation Scale Caregiver version
Cognitive ability: Mini Mental State Examination
Caregiving burden: Zarit Caregiver Burden Short version
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
Patients and caregivers receive from interventional staffs the support program sessions (approximately 10 sessions) which each lasts for an hour, with a frequency of once a week to once a month.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients and caregivers who are able to fully understand the contents of the informed consent document and from whom written consent is obtained before participation.
2) Both patient and caregiver agree to participate in the study.
3) Patients and caregivers aged 18 or older at the time of informed consent.
4) Patients who are diagnosed with DM1 by genetic testing (DMPK gene).
5) Patients who are able to move independently by walking or using an assistive device/wheelchair.
6) A caregiver is defined as "a family member, relative, partner, or friend who lives with the patient, who is not in a caregiving profession, and who reduces the patient's burden due to illness regardless of the level of care provided".
Key exclusion criteria
1) If either the patient or caregiver is unwilling to participate in the study.
2) If patient has intake of antipsychotics and/or mood stabilizers.
3) If there was a change in dosage of antidepressants, anti-anxiety drugs, sleeping pills, Modafinil, and Ritalin in the past 12 months. However, intake of as-needed anxiolytics and sleeping pills are allowed.
4) If the caregiver is in caregiving profession.
5) Other cases in which the principal investigator or research co-investigator determines that the participant is not suitable for study participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Endo |
Organization
National Center of Neurology and Psychiatry
Division name
Hospital, Clinical Research Unit
Zip code
187-0031
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
endo@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Endo |
Organization
National Center of Neurology and Psychiatry
Division name
Hospital, Clinical Research Unit
Zip code
187-0031
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
endo@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
MEXT (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization, Aomori Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
Tel
042-341-2711
ml_rinri-jimu@ncnp.go.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
| 2022 | Year | 10 | Month | 11 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2022 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056005
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