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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039949
Receipt No. R000045552
Scientific Title The effect of community pharmacist intervention on dementia patients on care burden-development of an intervention protocol and feasibility study
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/27

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Basic information
Public title The effect of community pharmacist intervention on dementia patients on care burden-development of an intervention protocol and feasibility study
Acronym COMPREHEND study(1)(Feasibility study on the effect of community pharmacist on intervention for dementia patients)
Scientific Title The effect of community pharmacist intervention on dementia patients on care burden-development of an intervention protocol and feasibility study
Scientific Title:Acronym COMPREHEND study(1)(Feasibility study on the effect of community pharmacist on intervention for dementia patients)
Region
Japan

Condition
Condition Dementia
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of outcomes by community pharmacist's intervention on dementia patients
Basic objectives2 Others
Basic objectives -Others caregiver burden
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the caregiver burden scores
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Pharmaceutical care with active collection of patient's information from attending physician and care manager using originally created "Request format for Information Provision"
Interventions/Control_2 Usual care
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients with dementia who receive regular prescription medication at cooperating pharmacies
Key exclusion criteria (1) Patients receiving home care services by pharmacists
(2) Those who cannot obtain the consent to participate in the research from the patient or the substitute
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Mitsuko
Middle name
Last name Onda
Organization Osaka University of Pharmaceutical Sciences
Division name Department of Social and Administrative Pharmacy
Zip code 569 1094
Address 4-20-1, Nasahara, Takatsuki, Osaka
TEL +81-72-690-1059
Email onda@gly.oups.ac.jp

Public contact
Name of contact person
1st name Mitsuko
Middle name
Last name Onda
Organization Osaka University of Pharmaceutical Sciences
Division name Department of Social and Administrative Pharmacy
Zip code 569 1094
Address 4-20-1, Nasahara, Takatsuki, Osaka
TEL +81-72-690-1059
Homepage URL
Email onda@gly.oups.ac.jp

Sponsor
Institute Osaka University of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Osaka University of Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics review Committee of Osaka University of Pharmaceutical Sciences
Address 4-20-1, Nasahara, Takatsuki, Osaka
Tel +81-72-690-1103
Email kenkyus@gly.oups.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
2020 Year 04 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 19
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
2017 Year 11 Month 13 Day
Date of IRB
2017 Year 11 Month 13 Day
Anticipated trial start date
2017 Year 11 Month 30 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 26 Day
Last modified on
2020 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045552

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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