UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial.
Title of the study (Brief title)	The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial.
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus at 6 months.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change in medication adherence from baseline to 6 months.
Key secondary outcomes	Change or percent change in following items from baseline to 1, 3, 6 months. 1) Medication adherence 2) Health literacy 3) HbA1c 4) self efficacy

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	YES
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	Received biweekly text messages on their cellphones to take their medication and improve their health literacy for 6 months.
Interventions/Control_2	Received biweekly text messages on their cellphones to only take their medication for 6 months.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Japanese. 2) Age >=18 years old. 3) The reason of hospitalization is to take the education of diabetes. 4) HbA1c >= 6.5%. 5) Taking oral medications or injectable medication. 6) To be able to get and access text messages on their cell phone. 7) Don't be diagnosed the depression. 8) Received informed consent.
Key exclusion criteria	No consent.
Target sample size	100

Research contact person
Name of lead principal investigator	Hideki Sugita
Organization	Showa University
Division name	School of Pharmacy, Department of Hospital Pharmaceutics
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8467
Email	hsugita@cmed.showa-u.ac.jp

Public contact
Name of contact person	Hideki Sugita
Organization	Showa University
Division name	School of Pharmacy, Department of Hospital Pharmaceutics
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8467
Homepage URL
Email	hsugita@cmed.showa-u.ac.jp

Sponsor
Institute	Department of Health Sciences, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Japan
Institute
Department

Funding Source
Organization	Department of Health Sciences, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Japan
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	山梨大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 02 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 02 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2014 Year 09 Month 30 Day
Date of closure to data entry	2014 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded	2014 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 02 Day
Last modified on	2016 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017145