UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Medication Adherence Improvement Program for the Hypertensive Elderly Living Alone : Randomized Controlled Trial
Acronym	Effect of Medication Adherence Improvement Program for the Hypertensive Elderly Living Alone
Scientific Title	Effect of Medication Adherence Improvement Program for the Hypertensive Elderly Living Alone : Randomized Controlled Trial
Scientific Title:Acronym	Effect of Medication Adherence Improvement Program for the Hypertensive Elderly Living Alone
Region	Japan

Condition
Condition	Hypertensive
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to implement a program to improve medication adherence for elderly people living alone with hypertension and to verify the effect of the program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from the baseline by Medication Adherence Scale
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Interventions Educate to improve medication adherence
Interventions/Control_2	Control 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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Over 70 years old 2.During an outpatient visit that is taking medication for hypertensive 3.Living alone 4.low medication adherence
Key exclusion criteria	1.Dementia 2.Taking antidepressants 3.Cannot go out alone as a physical function 4.Poor eyesight / hearing or dysphagia that interfere with daily life
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Chise Middle name Last name Yamamoto
Organization	Japanese Red Cross Hiroshima College of Nursing
Division name	Adult Health Nursing
Zip code	738-0052
Address	1-2 Ajinadai-higashi, Hatsukaichi, Hiroshima
TEL	0829-20-2800
Email	cy11172@jrchcn.ac.jp

Public contact
Name of contact person	1st name Chise Middle name Last name Yamamoto
Organization	Japanese Red Cross Hiroshima College of Nursing
Division name	Adult Health Nursing
Zip code	738-0052
Address	1-2 Ajinadai-higashi, Hatsukaichi, Hiroshima
TEL	0829-20-2800
Homepage URL
Email	cy11172@jrchcn.ac.jp

Sponsor
Institute	Japanese Red Cross Academy
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Committee, Japanese Red Cross Hiroshima College of Nursing
Address	1-2 Ajinadai-higashi, Hatsukaichi, Hiroshima
Tel	0829-20-2800
Email	rinri@jrchcn.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	2021 Year 12 Month 27 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
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	Preinitiation
Date of protocol fixation	2021 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 04 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 27 Day
Last modified on	2021 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053047