Awareness Development and Usage of mHealth Technology Among Hypertensive Patients in a Rural Community of Bangladesh
1 other identifier
interventional
420
1 country
1
Brief Summary
To develop awareness, enhance knowledge, attitude and make behavioral changes by using health education and mHealth technology among hypertensive patients in a rural community of Bangladesh, A Randomized Controlled Trial will be conducted in a rural community around Kumudini Women's Medical College and Hospital, Mirzapur, Bangladesh, intervention period will be consecutive 5 months and 210 in each group (total 420). Face to face interviews will be conducted to develop awareness among hypertensive individuals as part of the provision of improved health care services. The face to face interview will take place at Kumudini Hospital or in the community. Face to face interviews will help to understand the individuals' perceptions, attitudes, and practices associated with compliance to treatment and behavior change. Additionally, the study will identify major barriers related to hypertension associated with healthcare-seeking behaviors. Subjects will be diagnosed cases of hypertension. The selection criteria would be: individuals aged 35 years and more, have at least 1-5 years of schooling, who are open and can exchange their views freely as well as who can be asked in-depth and probing questions. Moreover, specimens will be collected to examine for serum total cholesterol, random blood sugar, urinary salinity, and urinary protein. Physical measurements like height in meter, weight in kg, MUAC in millimeter, hip and waist ratio will be performed from the day of enrollment till the end of follow up. If the participant agrees to participate, they will be asked questions about their lifestyle, present health status, and socio-demographic characteristics. The interview will around 30 minutes of their time, measurement of nutritional status (height, weight, MUAC, hip circumference, and waist circumference), and specimen collection for laboratory tests (blood and urine) will take another 30 minutes. Initially, the follow-up visits will be twice a month then once a month up to 4 consecutive months. Interviews will be conducted in the Kumudini Women's Medical College and Hospital. The data will be securely stored in a locked room. Data will be processed and analyzed by using the statistical software packages SPSS for Windows version 21.0 and Epi Info version 6.0. Statistical significance will be defined as p\<0.05.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Aug 2018
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedStudy Start
First participant enrolled
August 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2019
CompletedDecember 11, 2019
December 1, 2019
12 months
July 27, 2018
December 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Behavioral change
By health education Operational Definition: Increased awareness, knowledge, and attitude changes will be measured by actual behavior change of participants. Once participants will aware the importance of lifestyle change, obtain knowledge about the way of change, and intend to change, the participants will change their lifestyles. Thus, we can measure these changes by actual behavior. Behavioral changes by health education (evaluated by the researcher who developed questionnaire). Operational Definition: Increased awareness, knowledge, and attitude changes will be measured by actual behavior change of participants. Once participants will aware the importance of lifestyle change, obtain knowledge about the way of change, and intend to change, the participants will change their lifestyles. Thus, we can measure these changes by actual behavior. Behavioral changes by health education (evaluated by the researcher who developed questionnaire).
Intervention period is 5 months
Secondary Outcomes (1)
Improve quality of life
Intervention period is 5 months
Study Arms (2)
mobile health technology
ACTIVE COMPARATORHealth education with mobile health technology
Without mobile health technology
SHAM COMPARATORHealth education without mobile health technology
Interventions
Health education through mobile technology with Short Message Service (SMS)
Eligibility Criteria
You may qualify if:
- Hypertensive individuals of either sex aged 35 years or older
- Have 1-5 years of schooling
- Resides within a radius of 3 miles from the Kumudini Women's Medical College and Hospital
- Who resides in that area at least 6 months
- Has a personal cell phone or access to a shared phone
- Who is open and can exchange his views freely
- Willing to participate in the study
- Who consents to receive and read periodic text messages for the entire study period.
You may not qualify if:
- Individuals with no hypertension aged less than 35 years
- Who don't have 1-5 years of schooling
- Resides beyond a radius of 3 miles from the Kumudini Women's Medical College and Hospital
- Who don't reside in that area at least 6 months
- With mental illnesses or serious co-morbidities or chronic illnesses that might cause periodic absence
- Without access to cell phone
- Not willing to participate
- Who don't want to give consent to receive and read periodic text messages for the entire study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kumudini Women's Medical College and Hospital,
Dhaka, Bangladesh
Related Publications (2)
Jahan Y, Rahman MM, Faruque ASG, Chisti MJ, Kazawa K, Matsuyama R, Moriyama M. Awareness Development and Usage of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Randomized Controlled Trial. J Med Internet Res. 2020 Dec 7;22(12):e19137. doi: 10.2196/19137.
PMID: 33284129DERIVEDJahan Y, Moriyama M, Rahman MM, Kazawa K, Rahman A, Sayeem Bin Shahid ASM, Das SK, Faruque A, Chisti MJ. Increasing Awareness and Use of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 17;9(8):e15523. doi: 10.2196/15523.
PMID: 32804088DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasmin Jahan
Hiroshima University
- STUDY CHAIR
Michiko Moriyama
Hiroshima University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 27, 2018
First Posted
August 3, 2018
Study Start
August 12, 2018
Primary Completion
July 23, 2019
Study Completion
July 23, 2019
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share