NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000035997

Registered date:01/03/2019

Effectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)

Basic Information

Public titleEffectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Scientific titleEffectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Recruitment statusComplete: follow-up continuing
Health condition(s) or Problem(s) studiedShort statue caused by -Growth hormone (GH) deficiency -Turner syndrome -Small for gestational age
Study typeObservational
Phase
Study design
Intervention(s)
Sample Size50
Date of first enrollment2019/03/01
Completion date31/05/2020
Countries of recruitmentJapan

Outcome(s)

Primary OutcomeMedication adherence of patients during 24 weeks of observation period.
Secondary Outcome-Patients characteristics at registration. -Time course change in medication adherence. -Nonadherence-free survival. -Questionnaire on GH therapy. -Questionnaire on mobile application. -Factors affecting adherence to GH therapy. -Exploratory analysis of application log data.

Key inclusion & exclusion criteria

Age minimum3years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria-Contraindications for GH therapy. eg, Diabetes, malignancy, (possible) pregnancy. -Not supposed to be able to answer the questionnaire properly, eg, unable to read. -Judgement of physicians.

Related Information

Primary SponsorDepartment of Pediatrics, Nihon University Hospital
Secondary
Source(s)JCR pharmaceuticals Co., Ltd.

Secondary Identifiers

Secondary ID

Contact

public contact
Name Urakami Tatsuhiko
Address 1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan Japan 101-8309
Telephone 81-3-3293-1711
E-mail urakami.tatsuhiko@nihon-u.ac.jp
Affiliation Nihon University Hospital Department of Pediatrics
scientific contact
Name Urakami Tatsuhiko
Address 1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan Japan
Telephone 81-3-3293-1711
E-mail urakami.tatsuhiko@nihon-u.ac.jp
Affiliation Nihon University Hospital Department of Pediatrics

Ethics Reviews

StatusYES
Approval Date10/01/2019
Contact NameEthics committee of Nihon university hospital
Contact Address1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
Contact Phone81-3-3293-1711
Contact Emailsuzuki.ikumi@nihon-u.ac.jp

Summary Results

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Baseline Characteristics
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Brief Summary
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IPD sharing statement

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