UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000015536
Receipt No. 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 (Ver. 5)

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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
Email 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
Email g_oyama@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018049