UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049367 |
|---|---|
| Receipt number | R000056220 |
| Scientific Title | Preventing Aggravation of Life-Style Diseases by Supporting Patients' Changing Behaviors at Community-Pharmacies. |
| Date of disclosure of the study information | 2022/10/30 |
| Last modified on | 2025/05/02 09:15:16 |
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Basic information
Public title
Preventing Aggravation of Life-Style Diseases by Supporting Patients' Changing Behaviors at Community-Pharmacies.
Acronym
PASSPORT
Scientific Title
Preventing Aggravation of Life-Style Diseases by Supporting Patients' Changing Behaviors at Community-Pharmacies.
Scientific Title:Acronym
Preventing Aggravation of Life-Style Diseases by Supporting Patients' Changing Behaviors at Community-Pharmacies.
Region
| Japan |
Condition
Condition
Hypertension, Type 2 diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of community pharmacists' intervention on patients associated with uncontrolled hypertension or uncontrolled hyperglycemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, HbA1c at 6 and 12 months
Key secondary outcomes
Eating habit
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Community pharmacists' advice on Eating habit (every visit at community pharmacies for 6 to 12 months)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertension: SBP>=140mmHg or DBP>=90mmHg
Type 2 Diabetes: HbA1c>=7%
Key exclusion criteria
Pharmacotherapy less than 6 months
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Tominaga |
Organization
Niigata University of Pharmacy and Applied Life Sciences
Division name
Faculty of Pharmaceutical Sciences
Zip code
956-8603
Address
265-1 Higashijima, Akiha-ku, Niigata
TEL
0250285306
y-tominaga@nupals.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Tominaga |
Organization
Niigata University of Pharmacy and Applied Life Sciences
Division name
Faculty of Pharmaceutical Sciences
Zip code
956-8603
Address
265-1 Higashijima, Akiha-ku, Niigata
TEL
0250285306
Homepage URL
y-tominaga@nupals.ac.jp
Sponsor or person
Institute
Niigata University of Pharmacy and Applied Life Sciences
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Pharmacy and Applied Life Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University
11 Community Pharmacies (Sado)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Pharmacy and Applied Life Sciences
Address
265-1 Higashijima, Akiha-ku, Niigata
Tel
0250255396
hirokawa@nupals.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
| 2022 | Year | 10 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056220
