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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042571
Receipt No. 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 2020/11/27

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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
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 Preinitiation
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 10 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 11 Month 27 Day
Last modified on
2020 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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