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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031192
Receipt No. 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

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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
Email 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
Email hashimoto.tomoaki@kameda.jp

Sponsor
Institute Kameda General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035614

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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