UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042571 |
|---|---|
| Receipt number | R000048591 |
| Scientific Title | Effects of Flail Prophylaxis Interventions by The Health Support Pharmacy Pharmacists on aged Chronic Disease Patients : a Practical Cluster Randomized Trial |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2021/11/29 08:17:05 |
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Basic information
Public title
Intervention study by pharmacy pharmacist to prevent flail
Acronym
Pharmacy flail study
Scientific Title
Effects of Flail Prophylaxis Interventions by The Health Support Pharmacy Pharmacists on aged Chronic Disease Patients : a Practical Cluster Randomized Trial
Scientific Title:Acronym
FHSP Trial
Region
| Japan |
Condition
Condition
Flail
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This time, for patients with chronic diseases aged 75 to 79 who use the health support pharmacy operated by Osaka Pharmaplan, the pharmacy pharmacist will provide information on frailty prevention measures at the time of medication instruction, so that the patients can Encourage daily exercise and try to verify whether it increases muscle mass.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The amount of change(Kg) and the rate of change(%) of "muscle mass by site" measured with a body composition analyzer after 6 months. The rate of change(%) after 6 months of the "5 times chair stand-up test".
Key secondary outcomes
The amount and rate of change of "body weight," "body fat percentage," "BMI," and "estimated bone mass" measured with a body composition analyzer after 6 months. Comparison between groups of the results of the "health status questionnaire" that was first surveyed and comparison of the amount of change in body composition. Evaluation of the results of the "retrospective questionnaire" surveyed 6 months later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
At the time of medication instruction, you will be given a leaflet of "Exercise to prevent flail at home" (Attachment 4) to prevent flail, and encourage daily exercise and exercise to prevent flail. At the time of the 2nd to 5th visits to the station, we will give you the flail prevention exercise leaflet that you gave at the first time, confirm that you are exercising, and encourage you to exercise and exercise for flail prevention again. If you have time, perform a "five chair stand-up test" and record it. After the 6th visit (final) medication instruction, measure "muscle mass", "weight", "body fat percentage", "BMI", "estimated bone mass", and "5th chair standing test" with a body composition analyzer, and "record" Record on "paper". Finally, please complete the "Reflection Questionnaire".
Interventions/Control_2
At the time of the 1st to 5th visits. Give normal medication guidance. At that time, check whether you are exercising every day. At the 6th visit. After taking the medicine, measure "muscle mass", "weight", "body fat percentage", "BMI", "estimated bone mass", and "5 times chair standing test" with a body composition analyzer and record them on a recording sheet. We will give you a leaflet of "Exercise for flail prevention that you can do at home" to encourage awareness and exercise for flail prevention. Please answer the "Reflection Questionnaire" and finish it once.
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
| 75 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Of the 12 pharmacies operated by Osaka Pharma Plan, 10 pharmacies that meet the standards of health support pharmacies (Aozora Pharmacy, Aozora Pharmacy Awaji Store, Aoba Pharmacy, Kagayaki Pharmacy, Kotsuma Pharmacy, Sumire Pharmacy, Soyokaze Pharmacy, Nagisa Pharmacy, Natsume Pharmacy, Moegi Pharmacy), among the patients who come to the pharmacy to receive prescription dispensing every month, are prescribed for chronic diseases (hypertension, diabetes, dyslipidemia, etc.) 75 years old to 79 years old Among the following patients, those who consented to this study are the target patients.
Key exclusion criteria
Patients who are undergoing treatment that may affect physical malnutrition or bones, such as cancer patients. Patients who are prescribed an osteoporosis drug. Patients who are prescribed antidepressants or antipsychotics. Patients who are prescribed steroids. Patients who are prescribed dementia medication. Obese patients with a BMI of 30% or higher. Patients receiving exercise restriction guidance from their doctor.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Noritake |
| Middle name | Noritake |
| Last name | Hirota |
Organization
General Incorporated Association Osaka Pharmaplan
Division name
Aozora Pharmacy
Zip code
5550024
Address
3-6-8, Nozato, Nishiyodogawa-ku, Osaka city, Japan
TEL
0664778088
n-hirota@faruma.co.jp
Public contact
Name of contact person
| 1st name | Noritake |
| Middle name | |
| Last name | Hirota |
Organization
General Incorporated Association Osaka Pharmaplan
Division name
Aozora Pharmacy
Zip code
555-0024
Address
3-6-8, Nozato, Nishiyodogawa-ku, Osaka city, Japan
TEL
0664778088
Homepage URL
n-hirota@faruma.co.jp
Sponsor or person
Institute
General Incorporated Association Osaka Pharmaplan Aozora Pharmacy
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association Osaka Pharmaplan Aozora Pharmacy
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
General Incorporated Association Osaka Pharmaplan Aozora Pharmacy
Address
3-6-8, Nozato, Nishiyodogawa-ku, Osaka city, Japan
Tel
0664778088
n-hirota@faruma.co.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
あおぞら薬局（大阪府）、あおぞら薬局淡路店（大阪府）、あおば薬局（大阪府）、かがや薬局（大阪府）、こつま薬局（大阪府）、すみれ薬局（大阪府）、そよかぜ薬局（大阪府）、なぎさ薬局（大阪府）、なつめ薬局（大阪府）、もえぎ薬局（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048591
