UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015317 |
|---|---|
| Receipt number | R000017815 |
| Scientific Title | Web-based questionnaire in patients with skin disorders; Adherence with oral and topical medications assessed by the Morisky Medication Adherence Scale-8 |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2014/10/02 12:22:13 |
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Basic information
Public title
Web-based questionnaire in patients with skin disorders; Adherence with oral and topical medications assessed by the Morisky Medication Adherence Scale-8
Acronym
Web-based questionnaire in patients with skin disorders (Adherence in dermatology)
Scientific Title
Web-based questionnaire in patients with skin disorders; Adherence with oral and topical medications assessed by the Morisky Medication Adherence Scale-8
Scientific Title:Acronym
Web-based questionnaire in patients with skin disorders (Adherence in dermatology)
Region
| Japan |
Condition
Condition
Atopic dermatitis / Urticaria /
Psoriasis / Tinea
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the level of adherence to oral and topical medications and to analyze factors associated with MMAS-8 score
Basic objectives2
Others
Basic objectives -Others
Medication adherence assessed by MMAS-8
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
MMAS-8 score categories (High/Medium/Low)
Cronbach's alpha
Key secondary outcomes
age, sex, marital status, annual income, employment, education, smoking, alcohol consumption, dermatological diagnosis, frequency of hospital visit, main healthcare institution, oral and topical medication, awareness of drug efficacy, experience of adverse events, overall satisfaction with treatment
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with atopic dermatitis, urticaria, psoriasis or tinea who got the medical care at a clinic/hospital within one year
Key exclusion criteria
Less than 16 years old
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masutaka Furue |
Organization
Graduate School of Medical Sciences,
Kyusyu University
Division name
Department of Dermatology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
TEL
092-641-1151
furue@dermatol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Fukumoto |
Organization
Medical Professional Relations KK
Division name
ac
Zip code
Address
8F,3-8,Kandaogawa-machi, Chiyoda-ku, Tokyo 101-0052, Japan
TEL
03-3518-2284
Homepage URL
mpr.kk@m-p-r.co.jp
Sponsor or person
Institute
Adherence Committee for Dermatosis
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medication Adherence assessed by MMAS-8
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2014 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017815
