UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039949 |
|---|---|
| Receipt number | 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 10:27:51 |
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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
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
onda@gly.oups.ac.jp
Sponsor or person
Institute
Osaka University of Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045552
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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