UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031192 |
|---|---|
| Receipt number | R000035614 |
| Scientific Title | Effectiveness of multidisciplinary medical team education for heart failure patients to improve their medication adherence |
| Date of disclosure of the study information | 2018/02/07 |
| Last modified on | 2020/02/14 10:44:27 |
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Basic information
Public title
Effectiveness of multidisciplinary medical team education for heart failure patients to improve their medication adherence
Acronym
Effectiveness of multidisciplinary medical team education for heart failure patients to improve their medication adherence
Scientific Title
Effectiveness of multidisciplinary medical team education for heart failure patients to improve their medication adherence
Scientific Title:Acronym
Effectiveness of multidisciplinary medical team education for heart failure patients to improve their medication adherence
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate medication adherence for heart failure patients in Japan. And we clarify the effectiveness of multidisciplinary medical team education to improve their medication adherence.
Basic objectives2
Others
Basic objectives -Others
Medication adherence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of adherence classification (High, Medium, Low) evaluated by the Morisky Medication Adherence Scale 8-items (MMAS-8)
Key secondary outcomes
1) Transition of MMAS-8 score of visit 1 and visit 2
2) Transition of Visual Analogue rating Scale (VAS) of patients admission, visit 1 and visit 2
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patient with consent ability.
2) Patients who are admitted to hospital resulted from acute heart failure.
3) Patients who are regularly used at least 1 medication for heart failure and co-morbidities causing the heart failure.
Key exclusion criteria
1) Death and changing departments during hospitalization.
2) Patient discharged to the medical facilities or other hospitals.
3) Patients after leaving hospital who visit other hospitals and clinics.
4) Dementia : Mini-Mental State Examination (MMSE) score <= 23.
5) Patient who are used no medication before admission.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Hashimoto |
Organization
Kameda General Hospital
Division name
Department of pharmacy
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
hashimoto.tomoaki@kameda.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Hashimoto |
Organization
Kameda General Hospital
Division name
Department of pharmacy
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
Homepage URL
hashimoto.tomoaki@kameda.jp
Sponsor or person
Institute
Kameda General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo University of Pharmacy and Life Sciences
The University of Tokyo, The Institute of Medical Science
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kameda General Hospital
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel
04-7092-2211
clinical_research@kameda.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
医療法人鉄蕉会 亀田総合病院 (千葉県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 07 | 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
40
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to incorrect use of MMAS-8 and VAS, accurate results could not be shown
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study to assess the level of adherence for patients who are admitted to hospital resulted from acute heart failure. During hospitalization, the multidisciplinary medical team educate those patients. After those patients leave hospital, medication adherence is evaluated with VAS and MMAS-8 in their first visit and second visit.
Management information
Registered date
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035614
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
