UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035997 |
|---|---|
| Receipt number | 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 09:34:17 |
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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
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
urakami.tatsuhiko@nihon-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Nihon University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040956
