UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036626 |
|---|---|
| Receipt number | R000041728 |
| Scientific Title | Prevalence of sleep-related problems and Sleep-related Characteristics among caregivers of Egyptian Parkinson's disease patients |
| Date of disclosure of the study information | 2019/04/30 |
| Last modified on | 2019/04/30 08:03:12 |
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Basic information
Public title
Prevalence of sleep-related problems and Sleep-related Characteristics among caregivers of Egyptian Parkinson's disease patients
Acronym
sleep-related problems and Characteristics among caregivers of Egyptian Parkinson's disease patients
Scientific Title
Prevalence of sleep-related problems and Sleep-related Characteristics among caregivers of Egyptian Parkinson's disease patients
Scientific Title:Acronym
sleep-related problems and Characteristics among caregivers of Egyptian Parkinson's disease patients
Region
| Africa |
Condition
Condition
cross-sectional analysis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Here we aim to study characteristics and prevalence of sleep-related problems among caregivers of Egyptian PD patients
Basic objectives2
Others
Basic objectives -Others
characteristics and prevalence of sleep-related problems among caregivers of Egyptian PD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the prevalence of sleep-related problems among sample of caregivers of Egyptian PD patients
Key secondary outcomes
correlation of clinical motor scales including H & Y scale and/or UPDRS in PD patients with severity of sleep-related problems among their caregivers.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PD patients with age above 50 years, of any gender, and caregivers with age above 18 years, of any gender were considered for inclusion
Key exclusion criteria
Excluded from enrollment were caregiver participants of Vascular PD (VP) or Parkinson plus syndrome (PPS) patients, and caregiver participants who refused consent, or with known history of sleep disorders and/or medications, psychiatric disorders and/or medications and medical conditions causing sleep problem including -but not limited to- thyroid or hepatic disorders.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Wael |
| Middle name | |
| Last name | Ibrahim |
Organization
kasralainy hospital, faculty of medicine, cairo university
Division name
Neurology
Zip code
11562
Address
Cairo
TEL
+201111919927
dr.wael_ezzat@residents.kasralainy.edu.eg
Public contact
Name of contact person
| 1st name | Wael |
| Middle name | |
| Last name | Ibrahim |
Organization
Kasralainy hospital, Faculty of Medicine, Cairo University
Division name
Neurology
Zip code
12411
Address
37 elhassan street, dokki
TEL
+201111919927
Homepage URL
dr.wael_ezzat@yahoo.com
Sponsor or person
Institute
Neurology department
kasralainy hospital, faculty of medicine, cairo university
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasralainy hospital, Faculty of Medicine, Cairo University
Address
37 elhassan street, dokki
Tel
+201111919927
dr.wael_ezzat@yahoo.com
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
Kasralainy hospital, Faculty of Medicine, Cairo University
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was conducted on Egyptian caregivers and their patients diagnosed with IPD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria5 presented to movement disorders clinic at Kasralainy hospital in period from May 2019 to April 2020. Caregiver was defined in our study according to NCI Dictionary of Cancer Terms as the person who gives care to PD patient who need help taking care of themselves, and may be health professionals, family members, friends, social workers, or members of the clergy. They may give care at home or in a hospital or other health care setting.
Those PD patients with age above 50 years, of any gender, and caregivers with age above 18 years, of any gender were considered for inclusion. Excluded from enrollment were caregiver participants of Vascular PD (VP) or Parkinson plus syndrome (PPS) patients, and caregiver participants who refused consent, or with known history of sleep disorders and/or medications, psychiatric disorders and/or medications and medical conditions causing sleep problem including -but not limited to- thyroid or hepatic disorders.
Management information
Registered date
| 2019 | Year | 04 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041728
