UMIN-CTR Clinical Trial

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
Email	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
Email	n-hirota@faruma.co.jp

Sponsor
Institute	General Incorporated Association Osaka Pharmaplan Aozora Pharmacy
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048591