UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052074 |
|---|---|
| Receipt number | R000059437 |
| Scientific Title | Demonstration of prescription drug delivery by drone in remote islands |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2025/04/11 14:43:25 |
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Basic information
Public title
Demonstration of prescription drug delivery by drone in remote islands
Acronym
Prescription drug delivery by drone in remote islands
Scientific Title
Demonstration of prescription drug delivery by drone in remote islands
Scientific Title:Acronym
Prescription drug delivery by drone in remote islands
Region
| Japan |
Condition
Condition
All diseases
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a medical service that consists of an online pharmacy service with prescription drug delivery by drone in remote islands, where there is no pharmacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Customer satisfaction
Key secondary outcomes
Cost of the service
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
A medical service that consists of an online pharmacy service with prescription drug delivery by drone
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients and family members who visit a clinic in a remote area with no nearby insurance pharmacy, agree to receive their medications at a collaborating pharmacy, and agree to the increased medical cost of the change from in-clinic prescriptions to out-of-clinic prescriptions during the study period
Key exclusion criteria
Patients prescribed narcotics, psychotropic drugs, poisonous drugs (anti-cancer drugs), and other drugs that are not allowed to be delivered according to the Japanese guidelines on the drone delivery of medicines
Patients for whom face-to-face medication guidance is required by the Japanese guidelines on online pharmacies
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Maeda |
Organization
Nagasaki University
Division name
Department of Island and Community Medicine, Graduate School of Biomedical Sciences
Zip code
853-8691
Address
205 Yoshikugicho, Goto, Nagasaki 853-8691 Japan
TEL
0959-74-2673
tmaeda@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyata |
Organization
Nagasaki University
Division name
Department of Island and Community Medicine, Graduate School of Biomedical Sciences
Zip code
853-8691
Address
205 Yoshikugicho, Goto, Nagasaki 853-8691 Japan
TEL
0959-74-2673
Homepage URL
j-miyata@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences Administration Department, Nagasaki University
Address
1-12-4 Sakamoto, Nagasaki, Nagasaki 852-8523 Japan
Tel
095-819-7195
gakujutu_gakuji@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.nagasaki-u.ac.jp/ja/science/science369.html
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/jgf2.768
Number of participants that the trial has enrolled
62
Results
A total of 62 patients participated in the demonstration, which was successful except for two patients whose drone deliveries were canceled because of strong winds. Most patients received their medications after more than an hour. Individual home delivery costs were involved because the delivery spot was restricted to the shore. More than 80% of the patients were satisfied with online medication counseling, but a few expressed the desire to receive their medication at the clinic.
Results date posted
| 2025 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 09 | Day |
Baseline Characteristics
A total of 62 patients participated in the demonstration.
Participant flow
We recruited patients and their families who visited Hisaka Clinic between October 3 and November 2, 2023, or Tamanoura Clinic on November 6, November 20, December 4, and December 18, 2023, and were prescribed medications. Of these, we excluded patients prescribed narcotics, some psychotropic medications, and toxic medications, which were not allowed to be delivered by drone under the guidelines as of March 2023.17 We invited all patients who did not meet the exclusion criteria to participate in this study for Hisaka Clinic, and at Tamanoura Clinic, we asked ~10 patients per day to participate, without specific selection criteria, owing to the high volume of daily patients.
Adverse events
In all drone deliveries, no in-flight problems, medication dropping outside the delivery spot, or damage to dropped medications were observed. No participants complained about damage to their medication.
Outcome measures
Time from the end of the medical consultation to the delivery of the medicines.
Results of questionnaire surveys to the participants, clinic, and pharmacy staff.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059437
