UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054438 |
|---|---|
| Receipt number | R000058272 |
| Scientific Title | A pilot study of Pharmacist-Dietician Collaborative support and Advice (PDCA) for patients with hypertension in community pharmacy: A single-arm, pre-post study |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2025/04/18 15:49:53 |
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Basic information
Public title
A pilot study of Pharmacist-Dietician Collaborative support and Advice (PDCA) for patients with hypertension in community pharmacy: A single-arm, pre-post study
Acronym
PDCA-hypertension Study
Scientific Title
A pilot study of Pharmacist-Dietician Collaborative support and Advice (PDCA) for patients with hypertension in community pharmacy: A single-arm, pre-post study
Scientific Title:Acronym
PDCA-hypertension Study
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Effectiveness of Collaboration between Pharmacy Nutritionists and Pharmacists in Supporting Dietary Habit Improvement for Patients with Hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic and diastolic blood pressure
Key secondary outcomes
Salt intake, DASH diet intake, degree of exercise habits, degree of alcohol consumption, Body Mass Index (BMI), medication adherence, and satisfaction with pharmacy services.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
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 dietitian working in the pharmacy collaborates with the pharmacist to provide dietary guidance after medication instruction.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with essential hypertension who have been taking blood pressure-lowering medication for at least one month and are expected to visit the pharmacy where the interventionist works on a regular basis
Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
Key exclusion criteria
1. patients who have difficulty in measuring blood pressure (dementia, taking antipsychotics or antidepressants, etc.)
2. patients undergoing treatment for diseases that may cause weight changes (malignant tumors, hypopituitarism, hyperthyroidism, gastric ulcer, etc.)
3. those who are already on a diet (e.g., those who are instructed by a physician to follow a special diet, those who are receiving private dietary support services, etc.)
4. other persons who are considered to have difficulty participating in the intervention study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Shoji |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Social and Administrative Pharmacy
Zip code
569-1094
Address
4-20-1, Nasahara, Takatsuki city, Osaka
TEL
072-690-1059
masaki.shoji@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Shoji |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Social and Administrative Pharmacy
Zip code
569-1094
Address
4-20-1, Nasahara, Takatsuki city, Osaka
TEL
0726831221
Homepage URL
masaki.shoji@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University study ethical committee
Address
2-7, Daigakucho, Takatsuki city, Osaka
Tel
072-683-1221
rinri@ompu.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
| 2024 | Year | 08 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058272
