UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031401 |
|---|---|
| Receipt number | 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 16:21:30 |
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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
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
d160207@hiroshima-u.ac.jp
Sponsor or person
Institute
Institute of of Biomedical and Health Sciences, Hiroshima University, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033736
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