UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000035614