UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031401
Receipt No. R000033736
Scientific Title Awareness Development using of mHealth Technology among Hypertensive Patients in Bangladesh
Date of disclosure of the study information 2019/04/10
Last modified on 2020/11/07 (Ver. 21)

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Basic information
Public title Awareness Development and Usage of mHealth Technology among Hypertensive Patients in a Rural Community of Bangladesh
Acronym Increase awareness & Health Literacy, Reduce Hypertension
Scientific Title Awareness Development using of mHealth Technology among Hypertensive Patients in Bangladesh
Scientific Title:Acronym Awareness, mHealth, Hypertension
Region
Asia(except Japan)

Condition
Condition Hypertensive people
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop awareness and enhance knowledge, which will be measured by actual behavioral changes, by using health education and mHealth technology among hypertensive patients in a rural communityof Bangladesh.

Basic objectives2 Others
Basic objectives -Others 2. To evaluate the level of blood pressure changes
3. To measure health status by Euro-5D-5L QOL questionnaire (Mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
4. To decrease dietary salt intake (Measured by food and urinary salinity test)
5. To measure blood glucose level (Random Blood Sugar), urinary protein and glucose test to measure complications.
6. To evaluate feasibility of this intervention strategies and mHealth technology.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavioral changes by health education (evaluated by the researcher who developed questionnaire).
Key secondary outcomes 1. To decrease level of blood pressure
2. To measure health status by Euro-5D-5L QOL questionnaire
3. To decrease dietary salt intake
4. To measure blood glucose level , Urinary Protein and glucose test
5. Check the feasibility of mobile phone in hypertensive individuals

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention:
For 5 months follow up with mobile health text messaging (SMS), first follow up 3 SMS per week for first month and 1 SMS per week for 4 months consecutively, face to face health education and also send text message (in bangla) from the day of enrollment to till follow up period. The SMS will provide simple health education and BP measurement reminders to encourage adherence to medical advice. Research team members will send a text message to a wired person having registered cell phone number throughout the study period.
Control:
12 months, 5 months follow up without mobile health text messaging (SMS).
Interventions/Control_2 Intervention:
For 5 months follow up with mobile health text messaging (SMS), first follow up 3 SMS per week for first month and 1 SMS per week for 4 months consecutively, face to face health education and also send text message (in bangla) from the day of enrollment to till follow up period. The SMS will provide simple health education and BP measurement reminders to encourage adherence to medical advice. Research team members will send a text message to a wired person having registered cell phone number throughout the study period.
Control:
12 months, 5 months follow up without mobile health text messaging (SMS).
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
35 years-old <=
Age-upper limit
36 years-old >=
Gender Male and Female
Key inclusion criteria Hypertensive individuals of either sex aged 35 years or older,1-5 years of schooling, Willing to participate in the study and who consents to receive and read periodic text messages for the entire study
Key exclusion criteria Individuals who did not meet the inclusion criteria.

Target sample size 420

Research contact person
Name of lead principal investigator
1st name Most Yasmin
Middle name
Last name Jahan
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 7348553
Address Minamiku 1-2-3, Kasumi-cho, Hiroshima, Japan
TEL 082-257-5365
Email d160207@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Most Yasmin
Middle name
Last name Jahan
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 7348553
Address Minamiku 1-2-3, Kasumi-cho, Hiroshima, Japan
TEL 082-257-5365
Homepage URL
Email d160207@hiroshima-u.ac.jp

Sponsor
Institute Institute of of Biomedical and Health Sciences, Hiroshima University, Japan
Institute
Department

Funding Source
Organization KAKENHI, Research advanced using Grants-in-Aid for Scientific Research.
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 Bangladesh Medical Research Council
Address Mohakhali, Dhaka 1212, Bangladesh
Tel +88-02-984-8396
Email info@bmrcbd.org

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 Kumudini Women's Medical College and Hospital

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 10 Day

Related information
URL releasing protocol https://www.researchprotocols.org/2020/8/e15523/
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/management/validator/63B797084160/citations/?start=0
Number of participants that the trial has enrolled 420
Results 
209 in intervention and 211 in the control arm. The adherence rates were significantly higher among the control group regarding salt intake behavior and physical activity behavior.
Results date posted
2019 Year 05 Month 16 Day
Results Delayed
Results Delay Reason Follow up has been completed on 23rd July 2019.
Date of the first journal publication of results
2020 Year 10 Month 26 Day
Baseline Characteristics 
In total, the mean age was 47.1(8.4) years; 86% were female, and 82% were housewives. Most of the participants had their spouses (90%), and 19% had an educational background of secondary schooling completed or higher. Moreover, more than 60% of participants were taking their antihypertensive medicine regularly. Regarding tobacco use, 26% of the total study participants took either/both smokeless tobacco and cigarettes whereas only 4% smoked cigarettes every day.
Participant flow 
412 participants finally completed the study.
Adverse events 
Not applicable
Outcome measures 
Primary:
1. Behavioral changes by health education 
Secondary:
1. To decrease level of blood pressure 
2. To measure health status by Euro-5D-5L QOL questionnaire (Mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
3. To decrease dietary salt intake (Measured by food and urinary salinity test)
4. To measure blood glucose level (Random Blood Sugar), Urinary Protein and glucose test (In order to measure the complications)
5. Check the feasibility of mobile phone in hypertensive individuals by field testing questionnaires which will be developed by the researchers
Plan to share IPD No plan yet.
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 09 Month 17 Day
Date of IRB
2017 Year 09 Month 17 Day
Anticipated trial start date
2018 Year 08 Month 12 Day
Last follow-up date
2019 Year 06 Month 18 Day
Date of closure to data entry
2019 Year 08 Month 31 Day
Date trial data considered complete
2020 Year 04 Month 10 Day
Date analysis concluded
2020 Year 04 Month 10 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 21 Day
Last modified on
2020 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033736