UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049274 |
|---|---|
| Receipt number | R000055927 |
| Scientific Title | A cluster randomized controlled trial of educational intervention by a community pharmacist to recommend ophthalmology visits for patients with diabetes mellitus |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2026/08/17 17:09:03 |
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Basic information
Public title
A cluster randomized controlled trial of educational intervention by a community pharmacist to recommend ophthalmology visits for patients with diabetes mellitus
Acronym
NANOHANA study
Scientific Title
A cluster randomized controlled trial of educational intervention by a community pharmacist to recommend ophthalmology visits for patients with diabetes mellitus
Scientific Title:Acronym
NANOHANA study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether patient education by community pharmacists using a study guide to recommend ophthalmology visits along with distribution of pamphlets on diabetic retinopathy decreases the number of diabetes patients with no ophthalmology visits compared with distribution of pamphlets alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of new visits to ophthalmology for diabetic retinopathy screening within six months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interventions: Provide a 30-minute online training session to community pharmacists in pharmacies assigned to intervention groups. The trained pharmacists will give recommendations of ophthalmology visits for diabetic retinopathy screening by using a study guide along with distribution of pamphlets on diabetic retinopathy.
Interventions/Control_2
Controls: Distribution of pamphlets on diabetic retinopathy.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who have been diagnosed with diabetes mellitus more than six months prior.
2)Patients who have been prescribed at least one medication for diabetes mellitus (injection and/or oral medicine).
3)Patients with no ophthalmology visits for diabetic retinopathy for at least 1 year prior.
4)Patients who have given consent.
Key exclusion criteria
1)Patients who have vision loss in both eyes.
2)Patients who do not have the ability to give consent or those who were absent at the time of consent.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Ogawa |
Organization
Total Medical Service Co., Ltd.
Division name
Operations Division
Zip code
811-0119
Address
4-17-2 Midorigahama Shingu-machi, Kasuya-gun, Fukuoka-ken Japan
TEL
+81-92-962-9200
ai.ogawa.tms@msnw.co.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Ogawa |
Organization
Total Medical Service Co., Ltd.
Division name
Operations Division
Zip code
811-0119
Address
4-17-2 Midorigahama Shingu-machi, Kasuya-gun, Fukuoka-ken Japan
TEL
+81-92-962-9200
Homepage URL
ai.ogawa.tms@msnw.co.jp
Sponsor or person
Institute
Medical System Network Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Total Medical Service Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Institute for Pharmacy Benefit Co.,Ltd.
Address
24-2-1 Kita10-jonishi Chuo-ku, Sapporo-shi, Hokkaido 060-0010 Japan
Tel
+81-11-613-3577
rinri-shinsa@iyakusoken.com
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
| 2022 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
nothing
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.37737/ace.26005
Number of participants that the trial has enrolled
268
Results
Ophthalmic visits occurred in 18.8% (25/133) of the intervention and 20.7% (28/135) of the control group, yielding no significant difference (model 1, risk difference [RD] -0.03 [-0.14 to 0.08], risk ratio [RR] 0.88 (0.54 to 1.45); model 2, RD -0.07 [-0.21 to 0.08], RR 0.73 [0.41 to 1.30]). There was no significant difference between the two groups in the mean changes from baseline to 6 months in behavior for ophthalmic visits (0.07 [-0.23 to 0.37]) and HbA1c levels (-0.28 [-0.76 to 0.20]).
Results date posted
| 2026 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Totally, the mean age of the participants was 60.1 (10.7) years, and 35.8% (96/268) of the participants were women. The median duration since the diagnosis of diabetes was 5.2 (2.4-10.8) years, and the mean HbA1c level was 7.5 (1.6), with 11.2% (30/268) being insulin users. A total of 3.7% (10/268) of patients with a history of retinopathy had not received ophthalmological care for more than a year and were included in this study.
Participant flow
A total of 278 patients were enrolled from 32 pharmacies between February 2023 and April 2024. Of these, 10 (3.6%) participants were excluded because they did not meet the following inclusion criteria: one was >=75 years and nine had visited an ophthalmologist within the past year. Ultimately, 268 patients were included and randomized to the intervention (n = 133) and control (n = 135) groups. Of the participants allocated to each group, data for the 6-month outcome was unavailable for 8 individuals in the intervention group (5 loss to follow up, 1 protocol deviation, and 2 declined to the answer the questionnaire), and 9 individuals in the control group also had unavailable data (9 loss to follow up).
Adverse events
No adverse events were observed.
Outcome measures
PRIMARY OUTCOME
In total, 19.8% (53/268) of the participants received ophthalmological care during follow-up period, with 18.8% (25/133) in the intervention group and 20.7% (28/135) in the control group (unadjusted risk difference, -0.03 [95% confidence interval [CI], -0.14 to 0.08]; unadjusted risk ratio, 0.88 [95% CI, 0.53 to 1.44]). In the multivariable model adjusted for age and sex, the adjusted risk difference and risk ratio were -0.03 (95% CI, -0.14 to 0.08) and 0.88 (95% CI, 0.54 to 1.45), respectively, with no significant difference observed. Similarly, in the multivariable model adjusted for age, sex, and factors associated with diabetic retinopathy, no difference was found between the two groups (adjusted risk difference, -0.07 [95% CI, -0.21 to 0.08]; adjusted risk ratio, 0.73 [95% CI, 0.41 to 1.30]).
SECONDARY OUTCOMES
The mean differences in change from baseline to 6 months in behavior for ophthalmic visits, dietary therapy, and exercise therapy across both groups were 0.07 (-0.23 to 0.37), -0.09 (-0.30 to 0.13), and 0.07 (-0.17 to 0.32), respectively, with no significant differences between the groups. Similarly, the mean differences in change from baseline to 6 months in adherence, HbA1c levels, and body weight were 0.24 (-0.14 to 0.63), -0.28 (-0.76 to 0.20), and 0.17 (-0.83 to 1.83), respectively, with no significant differences between the groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055927
