UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053789 |
|---|---|
| Receipt number | R000061315 |
| Scientific Title | Longitudinal Trajectory of Participation, Occupational Identity, Occupational Competence, and Occupational Adaptation in Parkinson's Disease - Cognitive and Psychological Predictors: Study Protocol for a Prospective Longitudinal Cohort Study |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/04 09:40:36 |
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Basic information
Public title
Longitudinal Trajectory of Participation, Occupational Identity, Occupational Competence, and Occupational Adaptation in Parkinson's Disease - Cognitive and Psychological Predictors: Study Protocol for a Prospective Longitudinal Cohort Study
Acronym
Cognitive and Psychological Predictors in Parkinson's Disease: Impact on Participation and Occupational Functioning - A Cohort Study
Scientific Title
Longitudinal Trajectory of Participation, Occupational Identity, Occupational Competence, and Occupational Adaptation in Parkinson's Disease - Cognitive and Psychological Predictors: Study Protocol for a Prospective Longitudinal Cohort Study
Scientific Title:Acronym
Cognitive and Psychological Predictors in Parkinson's Disease: Impact on Participation and Occupational Functioning - A Cohort Study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) to explore the trajectory of participation, occupational identity, occupational competence, and occupational adaptation, and (2) to examine the trajectory of participation, occupational identity, occupational competence, and occupational adaptation in relation to cognitive and psychological (fatigue, motivation, depression, anxiety, stress, sleep quality, life meaning, pain, apathy, loneliness, and fear of falling) factors trajectories.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigating the predictive role of cognitive and psychological functions for participation, occupational identity, occupational competence and occupational adaptation in people with idiopathic Parkinson's disease
Key secondary outcomes
Determining the longitudinal trajectory pattern of participation, occupational identity, occupational competence and occupational adaptation in people with idiopathic Parkinson's disease
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
| 35 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed by a neurologist based on UK Parkinson's Disease Society Brain Bank Diagnostic Criteria, classified as Hoehn and Yahr stages I to V, and aged > 35 years.
Key exclusion criteria
Participants with other concomitant neurological conditions and atypical parkinsonian disorders will be excluded.
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Jafar |
| Middle name | |
| Last name | Haj Ghani |
Organization
Iran University of Medical Sciences
Division name
Occupational Therapy
Zip code
1449614535
Address
Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
TEL
+98-9338107591
Jafar.hajghani@gmail.com
Public contact
Name of contact person
| 1st name | Ghorban |
| Middle name | |
| Last name | Taghizadeh |
Organization
Iran University of Medical Sciences
Division name
Occupational Therapy
Zip code
1449614535
Address
Shahnazari Street, Mirdamad Boulevard, Tehran, Iran
TEL
+98-9101462167
Homepage URL
Taghizadeh.gh@iums.ac.ir
Sponsor or person
Institute
Iran University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iran University of Medical Sciences
Address
Hemmat highway, Tehran, Iran.
Tel
+98-21-8670-1021
info@iums.ac.ir
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
| 2024 | Year | 04 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations include:
a) Demographic characteristics (age, gender, disease severity (Hoehn and Yahr stages), living situations, education, marital status, job status, fall history, disease duration, levodopa intake dosage, existence of tremor, diskinesia, freezing of the gait and freezing of the upper limbs).
b) Cognitive factors, as will be assess by: 1) Montreal cognitive assessment 2) Parkinson's disease cognitive rating scale 3) Stroop test,
c) Psychological factors (pain, anxiety, depression, stress, volition, fatigue, apathy, loneliness, fear of falling and balance confidence)
d) Participation
e) Occupational Adaptation
f) Occupational identity
g) Occupational competence
h) Sleep Quality
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061315
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
