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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035997
Receipt No. R000040956
Scientific Title Effectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Date of disclosure of the study information 2019/03/01
Last modified on 2021/04/26

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Basic information
Public title Effectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Acronym Effectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Scientific Title Effectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Scientific Title:Acronym Effectiveness of smartphone-based mobile application on medication adherence in patients receiving growth hormone therapy-An exploratory observational study. (GTL-App)
Region
Japan

Condition
Condition Short statue caused by
-Growth hormone (GH) deficiency
-Turner syndrome
-Small for gestational age
Classification by specialty
Endocrinology and Metabolism Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 -To prospectively investigate medication adherence of pediatric patients who initiate GH therapy using a smartphone-based mobile application.
-To explore factors associated with low adherence to GH therapy.
Basic objectives2 Others
Basic objectives -Others Effectiveness of a mobile application not classified as a medical device
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Medication adherence of patients during 24 weeks of observation period.
Key secondary outcomes -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.

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
3 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Never received growth hormone therapy before.
-Aged 3 years or older.
-Planning to:
-Use GROWJECTOR-L.
-Receive seven-days-a-week
administration.
-Use type A needles.
-Written informed consent from a legally acceptable representative of the patient, along with informed assent if applicable.
Key exclusion 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.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tatsuhiko
Middle name
Last name Urakami
Organization Nihon University Hospital
Division name Department of Pediatrics
Zip code 101-8309
Address 1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL 81-3-3293-1711
Email urakami.tatsuhiko@nihon-u.ac.jp

Public contact
Name of contact person
1st name Tatsuhiko
Middle name
Last name Urakami
Organization Nihon University Hospital
Division name Department of Pediatrics
Zip code 101-8309
Address 1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL 81-3-3293-1711
Homepage URL
Email urakami.tatsuhiko@nihon-u.ac.jp

Sponsor
Institute Department of Pediatrics, Nihon University Hospital
Institute
Department

Funding Source
Organization JCR pharmaceuticals Co., Ltd.
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 Ethics committee of Nihon university hospital
Address 1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
Tel 81-3-3293-1711
Email suzuki.ikumi@nihon-u.ac.jp

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 日本大学病院をはじめとする全国約40施設を予定

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022037/
Number of participants that the trial has enrolled 60
Results This study enrolled 60 children with short stature from 28 Japanese medical institutions and analyzed 57 of them. The median and mean adherence rates after 24 wk of observation were 96% and 93%, respectively. Although adherence rates were significantly lower from wk 16 to wk 20 than from wk 1 to wk 4, cumulative adherence rates remained high throughout the observation period. The questionnaire analysis revealed that most patients actively used the application.
Results date posted
2021 Year 04 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 04 Month 03 Day
Baseline Characteristics The mean age (SD) of the patients was 7.2 (3.84) yr, and the proportions of male and female patients was almost similar. A total of 54.4%, 7.0%, and 38.6% of the included patients were diagnosed with GHD, TS, and SGA, respectively. A relatively high proportion of patients were diagnosed with SGA. Among all patients, patients with SGA started GH therapy at the lowest age (P = 0.002). The baseline mean (SD) height SD score was -2.71 (0.57).
Participant flow This study enrolled 60 patients with short stature from 28 Japanese medical institutions. Three patients discontinued shortly after GH therapy initiation due to medication change, unbearable pain, and failure to return to the hospital and were subsequently excluded from the statistical analysis.
Adverse events N/A
Outcome measures Good adherence rates to GH therapy were observed with the use of the treatment-supporting application. Analyses of questionnaire answers revealed that most patients actively used the application.
Plan to share IPD N/A
IPD sharing Plan description N/A

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 01 Month 15 Day
Date of IRB
2019 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
2020 Year 09 Month 30 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information -To prospectively investigate medication adherence of pediatric patients who initiate GH therapy using a smartphone-based mobile application.

Management information
Registered date
2019 Year 02 Month 25 Day
Last modified on
2021 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040956

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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