UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015536 |
|---|---|
| Receipt number | R000018049 |
| Scientific Title | A Pilot Trial of Telemedicine for Parkinson's Disease |
| Date of disclosure of the study information | 2014/10/28 |
| Last modified on | 2020/01/29 21:36:37 |
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Basic information
Public title
A Pilot Trial of Telemedicine for Parkinson's Disease
Acronym
PD-Telemedicine
Scientific Title
A Pilot Trial of Telemedicine for Parkinson's Disease
Scientific Title:Acronym
PD-Telemedicine
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of telemedicine system utilizing tablet mobile on quality of life of patient with Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Parkinson's Disease Questionnaire (PDQ-39)
Key secondary outcomes
1. Unified Parkinoson's Disease Rating Scale (UPDRS) part I-IV
2. Modified Hoehn & Yahr scale
3. Beck Depression Inventory (BDI)
4. Questionnaires for participants
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interview utilizing Tablet.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with Parkinson's disease.
2. Age with 20-75.
3. Patients who can sign an informed consent form by him- or her-self.
4. Patients who can use iPad mini and have WiFi network environment.
Key exclusion criteria
1. Patients who connot sign an informed consent form by him- or her- self.
2. Patients who are regarded to inappropriate participant by researchers.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
g_oyama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
g_oyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Neuroscience and Mental Health
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.hindawi.com/journals/pd/2019/9403295/
Publication of results
Published
Result
URL related to results and publications
https://www.hindawi.com/journals/pd/2019/9403295/
Number of participants that the trial has enrolled
10
Results
We observed that a telemedicine system delivered via a tablet could successfully be used by patients with Parkinson's Disease as a part of their care.
Results date posted
| 2020 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with Parkinson's Disease
Participant flow
Patients were randomized to receive either the telemedicine period followed by the control period, or the control period followed by the telemedicine period, with both periods lasting 6 months.
Adverse events
no
Outcome measures
1) Primary outcome
The Parkinson's Disease Questionnaire (PDQ-39)
2) Secondary outcomes
[1] Unified Parkinoson's Disease Rating Scale (UPDRS) part I-IV
[2] Modified Hoehn & Yahr staging scale
[3] Beck Depression Inventory (BDI)
[4] The Parkinson's Disease Questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 27 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018049
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