UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058220 |
|---|---|
| Receipt number | R000066552 |
| Scientific Title | Impact of a Pharmacy-Based Headache Consultation Program on Pharmacists' Knowledge, Attitude and Confidence: Pre-Post Trial |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/14 15:47:25 |
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Basic information
Public title
Trial to Evaluate the Impact of a Pharmacy-Based Headache Consultation Program on Pharmacists' Knowledge, Attitude, and Confidence
Acronym
HELP Trial
Scientific Title
Impact of a Pharmacy-Based Headache Consultation Program on Pharmacists' Knowledge, Attitude and Confidence: Pre-Post Trial
Scientific Title:Acronym
HELP Trial
Region
| Japan |
Condition
Condition
Headache
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial will first deliver an online training program on headache to pharmacists working in Japanese community pharmacies. After completing the training, a 4-week practice-based intervention will be implemented in which pharmacists integrate a headache consultation tool - comprising a symptom checklist and symptom-specific educational materials - into their routine medication counseling.
The primary objective is to evaluate changes in pharmacists' knowledge about headache, attitudes toward headache counseling, and confidence (Knowledge-Attitude-Confidence; KAC) from pre-training to 4 weeks after the start of the intervention.
Secondary objectives include assessing changes in KAC scores from pre-training to immediately post-training, and from post-training to four weeks after the start of the intervention. In addition, the continuation rate of tool use at 12 weeks and the cumulative number of educational materials distributed by the end of the intervention will be evaluated. Through these evaluations, this trial aims to clarify the educational effectiveness of the headache consultation support program and explore its potential for social implementation in community pharmacies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pharmacists' knowledge, attitude and confidence about headache from pre-training to 4 weeks after the start of the intervention.
Key secondary outcomes
1.Change in pharmacists' knowledge, attitude and confidence about headache from pre-training to immediately post-training
2.Change in pharmacists' knowledge, attitude and confidence about headache from immediately post-training to 4 weeks after the start of intervention
3.Proportion of pharmacists continuing to use the headache consultation tool at 12 weeks after the start of the intervention
4.Cumulative number of each educational material distributed by the end of the intervention
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A pre-intervention online training session will be conducted to provide pharmacists with knowledge about headaches and instructions on how to use the original Headache Consultation Tool. After completing the training, participating pharmacists will use the Headache Consultation Tool in routine medication counseling for 4 weeks.
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
Pharmacists who are currently working in community pharmacies.
Key exclusion criteria
1)Pharmacists who did not provide informed consent.
2)Pharmacists who were scheduled to take maternity leave, childcare leave, or other extended leave during the study period.
3)Pharmacists who were expected to leave their current pharmacy during the study period.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okada |
Organization
School of Pharmaceutical Sciences, Wakayama Medical University
Division name
Department of Social & Community Pharmacy
Zip code
6408156
Address
25-1 Shichibancho, Wakayama-shi, Wakayama-ken, Japan
TEL
073-488-3147
okada_h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koyu |
| Middle name | |
| Last name | Ishihara |
Organization
School of Pharmaceutical Sciences, Wakayama Medical University
Division name
Department of Social & Community Pharmacy
Zip code
6408156
Address
25-1 Shichibancho, Wakayama-shi, Wakayama-ken, Japan
TEL
073-488-3147
Homepage URL
p2230009@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board(IRB), Wakayama Medical University
Address
881-1 Kimiidera, Wakayama City, Wakayama Prefecture, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2025 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066552
