Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03614104 |
| Other study ID # |
18H03111300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 12, 2018 |
| Est. completion date |
July 23, 2019 |
Study information
| Verified date |
December 2019 |
| Source |
Hiroshima University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Introduction:
Hypertension is one of the foremost non-communicable diseases (NCDs)c in the world, which
significantly contributes to the burden of cardiovascular diseases (CVDs), stroke, kidney
failure, disability, and premature death. It is also recognized as a global public health
problem and ranked third as a cause of disability-adjusted life-years (DALYs). According to
the World Health Organization (WHO), about 17 million deaths occur worldwide due to CVDs, of
which hypertension alone accounts for 9.4 million deaths and 80% of the CVD-related deaths
occurred in the developing countries. The global prevalence of hypertension is projected to
increase from 26% in 2000 to 29% by 2025, which will be approximately 29% of the world's
population. Its prevalence is increasing in the low and middle-income countries (LMIC),
especially Southeast Asia where individuals are having an increasing burden of hypertension
including CVDs. According to WHO, hypertension has become a significant health concern in the
Asian region, affecting more than 35% of the adult population. Bangladesh, a developing
country in South Asia, has been experiencing an epidemiologic transition from communicable
diseases to NCDs. In recent years, rapid urbanization, prolonged life expectancy, unhealthy
diet, and lifestyle changes have led to an increase in the rate of CVD including hypertension
in Bangladesh. In recent years, in Bangladesh, approximately 20% of adults and 40-65% of
elderly people suffer from HTN. Most of the common reasons are sedentary lifestyle, changing
food habit, smoking, and adulteration of food products, fruits, and vegetables. However,
keeping in mind the changes in lifestyle and food habits among the young adults in
Bangladesh, the possibilities of hypertension in young adults can't be ruled out among this
age group. In this study, we aim to develop awareness, enrich knowledge and make behavioral
modifications by health education and mHealth technology among hypertensive patients in a
rural community of Bangladesh.
Objectives:
General objective:
1. 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 community of Bangladesh.
Specific objectives:
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 the feasibility of this intervention strategies and mHealth technology.
Hypothesis:
Here we hypothesize that hypertensive patients because of health education and mHealth
technology applications (cell phone monitoring of BP and periodic behavioral change education
- drug adherence) and follow-up will have decreased blood pressure (BP) relative to controls
under medication but without any mHealth technology applications. Compared to controls,
intervention patients at follow-up will report quality of life, behavioral change, dietary
habit as well as their greater satisfaction with care.
Sample size calculation In this study we have considered two groups, intervention group (PI;
health education with text messaging) and control group (PC; health education without text
messaging). In each group a proportion of the participants will respond to the intervention;
PI and PC. When the intention of the study is to show that the intervention group is superior
than the usual formulation of null hypothesis (PI>PC).
In this study the investigators want to compare between two interventions (health education
with or without text messaging). Investigators regard the compliance as PI>PC. We assume
that, if the proportion of patients with compliance is at most 10% to 12% better in the
health education with text messaging group.
Sample size was calculated with 2-tailed 5% significance level, power 80% with a confidence
level of 95% (1‐α) and to detect varying differences in the effectiveness of the two
intervention groups. Assuming adherence rates differing between 10-12% with 90% in the study
group and 78%, 79% and 80% respectively in the control group and with a presumption that 6%
of the participants would be lost during follow-up. The sample size was calculated to range
between 153-210 in each group. Thus, considering the largest size of the calculated sample
sizes, the study finally had a sample size of 210 in each group.
Randomization:
A randomization schedule is being prepared following a permuted block randomization technique
using a block size of four based on a computer-generated series of numbers. An experienced
researcher (third party), who is not involved with the study generated the random allocation
by sequence and distributed that in serially numbered sealed opaque envelopes which are being
kept in locked file cabinets in a site away from trial's location. Thus, all CHWs and the
principal investigator (PI) are kept blinded about the random allocation. A total of eight
CHWs are being involved in participants' enrollment under the guidance of the PI. Sequential
ID numbers of the potential participants are arranged by the PI immediately before enrolling
in the field on a daily basis. Enrollment takes place during morning hours for consecutive 6
days (except Friday) in a week. CHWs open the envelope in front of the participants at their
household when they agree to be enrolled in the study by giving written informed consent.
Enrollment of participants:
The study will be implemented at Kumudini Women's Medical College and Hospital immediately
after getting IRB approval from Bangladesh Medical and Research Council (BMRC). Hypertensive
patients living in rural Mirzapur will be mostly identified from Mirzapur Kumudini Hospital.
Additionally, study participants will be selected from the community by the door to door
visits. The diagnosis of hypertension will be based on the prescription and Kumudini hospital
database records.
Study Activities and Data Collection Procedure:
Qualitative study
The present qualitative assessment will follow an exploratory study design. The study will
particularly aim to comprehend the knowledge level in relation to hypertension in a rural
community of Bangladesh. To achieve the study objectives, this study will adopt focus group
discussion (FGD), in-depth-interviews (IDI), and key informant interviews (KII). These tools
are omnipresent in qualitative study and provide subjective perceptions from community and
individual perspectives.
Target population The inclusion criteria of these specific predefined participants for KII
and IDI will be as follows: (i) male and female individuals aged ≥35 years, (ii) diagnosed
recently or before as a hypertensive or non-hypertensive individual through review of
hospital logs, and prescriptions (iii) physically and intellectually able to travel, attend
and talk in interviews and actively participate in discussions, and (iv) who can be asked
probing questions, can share their knowledge, perception, attitude towards hypertension and
mHealth technology freely.
Qualitative study sample size:
Following number of participants will be interviewed:
Data collection tools Number of participants Key informant interview 6-8 (3-4 M & 3-4 F)
In-depth interview 6-8 (3-4 M & 3-4 F) FGD with hypertensive male and female participants
60-80 (30/40 M & 30/40 F)
Data collection
The data will be collected through individual interviews (key informant interviews) and group
interviews (focus group discussions).
1. Focus group discussion (FGD)
FGD will be conducted in individuals with and without hypertension including both male
and females at the community level to understand their perceptions, symptoms, knowledge,
motivations, beliefs and attitude towards hypertension and mHealth technology and their
practices related to healthcare at household and community level.
2. In-depth interview (IDI)
The in-depth interviews will be conducted with 3-/4 people with hypertension and 3-/4
people without hypertension both male and female who are individuals of either sex from
local community to understand their perceptions, knowledge about symptoms of
hypertension, motivations, beliefs and attitude towards hypertension and mHealth
technology and their health care seeking practices and compliances towards drugs and
instructions.
3. Key informant interview (KII)
In relation to the study objectives, the study will conduct key informant interviews to
develop an insight of individuals regarding the symptoms, causes and consequences of
hypertension, the importance of lifestyle modification and regular check-ups in controlling
hypertension or barriers and challenges that keep them away from regular checkups and
medication adherence. Moreover, the systems that affect mobile health related health care
services at the local level, potential barriers and challenges, and issues that may need
further attention will be identified.
Data Management and Analysis
Data from field will follow a step-by-step data management procedure:
1. Data labelling (naming the recorded and transcribed files)
2. Transcription (both in Bangla and English)
3. Data cleaning (recover missing data)
4. Data compilation with field notes (check the accuracy and brevity)
5. Data storage (both soft and hard copy in a safe and secure place with restricted access)
Data Analysis After having a good sense of field data, the research team will initiate a
thematic/content analysis based on available data. Both inductive (bottom-up: emerging from
field data) and deductive (top-down: theory driven) approach of coding and themes
(/sub-themes) selection will be taken into consideration. However, it is important to note
that data analysis in a qualitative study is consistent process rather than step-by-step.
Data coding At first, transcripts will be reviewed carefully and re-read for producing a code
book. Reading and coding will initiate while data are being collected.
Data presentation The data display and reduction process will be conducted once all data have
been collected. Even during data display and reduction, the investigators will loop back
through earlier steps to refine codes, re-read texts and revise some aspects of analysis.
After reading, re-coding and coding the text, the main themes will be formalized.
Enrollment of participants for RCT:
Immediately before the implementation of the research, a structured questionnaire will be
developed based on past experience in rural Bangladesh and elsewhere, which will be discussed
thoroughly with field staff members and extensive field-testing will be done for necessary
modifications of the questionnaire. Using a standardized pre-tested questionnaire, the
socio-economic status and demography ( age, sex, religion, financial dependency, educational
qualification, occupation, monthly family income and expense, type of house, type of family,
marital status, living arrangements and so on) health status, health care seeking behavior,
food consumption practices, life styles such as tobacco consumption, level of physical
activity and other relevant information will be obtained. Moreover, blood and urine specimens
will be collected and laboratory tests like serum total cholesterol, random blood sugar,
urinary salinity, and urinary protein, glucose will be performed. Measurements of nutritional
indices such as height, weight, MUAC, hip circumference, and waist circumference will be
carried out from the enrollment day till end of follow up. Follow up and physical examination
will take place at Kumudini Hospital or in the nearest Health and Family Welfare Center. In
this study, we will use a portable health clinic device which is recommended by Grameen
health program and by using this device we can save our time, as this device has all the test
and measurement facilities which we will do in our study. Six follow up visits will be
undertaken during the study period. Initially follow up visits will be twice a month then
once a month up to 4 consecutive months.
Moreover, staff members will be trained on use of all hardware. Usability evaluation of the
staff members will be performed to document (a) user performance and understand common errors
that are made by them while using the devices, (b) understand user perceptions and their
suggestions in better usage of the devices. Similar usability evaluation of the 10-15
hypertensive individuals will be conducted. The evaluation will be conducted in a quiet
environment with no distractions. Five qualitative questions will be asked to understand the
practical benefits and drawbacks of the devices. SMS messages will be developed in native
language by the members of the research team representing different professional background;
these messages will be sent to 10-15 people (randomly) for their comprehension and
acceptability as part of field-testing. The wired intervention individuals will receive short
messaging service (SMS) and they will have liberty to participate additionally in two-way
communication system (between wired individuals and research team members). After receiving
feedback, messages will be finalized. 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. SMS (First month: 3 SMS per week, and then third month to five months: 1 SMS
per week).
All the enrolled patients will receive health education booklets created by the researchers
based on Dietary Approaches to Stop Hypertension (DASH) diet as well as a self-management
notebook we will provide to participants in which the they will record blood pressure, body
weight and lifestyle improvement goals. The education booklets will be selected for that it
will suitable for the individual participant. Any abnormalities in the monitored values or
data or exacerbation of participant symptoms will be reported immediately to the primary care
physician.
SMS content:
Diet Reduce sodium (salt) intake WHO recommended sodium intake is 5g/day Eat more fruits,
vegetables and more fiber
Dietary Approaches to Stop Hypertension (DASH) eating plan:
It is high in fruits and vegetables, low-fat dairy, and fiber. Patients who strictly follow
the DASH eating plan can also have fairly significant reductions in weight, particularly when
combined with a low-sodium diet. Lifestyle, Stop smoking, Stop taking alcohol, Caffeine,
Exercise: Regular exercise (walking, running) for 20 to 30 minutes most days of the week can
lower your blood pressure, Reduce weight, Reduce stress, Monitor your blood pressure at home,
Control blood pressure during pregnancy, Medication: Take medication regularly
Economic evaluation
Researchers have recommended with emphasis on economic evaluation of health promotion
interventions such as health education and mobile health technology (SMS).
For this evaluation, the estimated cost of the program as well as costs for activities will
be measured using ingredients approach, which includes listing of all types of inputs by
identification of activities, quantities used, and prices for each input. Activity-based
costing (ABC) techniques will be attempted to assign costs to each of the activities in the
production process and/or resources. For this purpose, all costs will be classified according
to major activities and/or resources. All activities and their associated inputs will be
identified, and their respective costs will be obtained. Costs will be derived from two
phases of the intervention named start-up cost and implementation cost which are directly
related to the study. Total costs will be considered as the summation of capital and
recurrent cost items for each phase. A comprehensive list of cost-related items will be made,
and finally, cost per session per beneficiary will be estimated by dividing the total
provider cost per session with the number of beneficiaries who received the SMS. The
estimation of the cost will be covered the additional costs only that will include all field
and administrative activities. Costs incurred other than intervention activities of the
project such as salary, transportation, and data collection will be excluded from the
estimation. Moreover, a household out of pocket expense/cost will be measured to assess any
costs incurred for receiving the treatment or related to treatment. All necessary data will
be extracted from the project's documents, and project staff members will be interviewed
whenever necessary.
Objectives of the study are;
1. To capture the care seeking pattern due to chronic disease and other illness also.
2. To estimate the treatment cost from household perspectives due to chronic disease and
other illness also.
3. To estimate the program cost from supply side perspective.
4. To conduct a Cost-Effectiveness Analysis (CEA) of the program.
Program costs/provider perspective
Start-up cost
Implementation cost
Household costs/household perspective
Cost-Effectiveness analysis
Cost-effectiveness ratio of the intervention package will finally be calculated using the
cost of the whole program. Net cost of intervention and its effectiveness will be measured by
comparing cost and effectiveness in intervention and control groups. Cost-outcome ratio as
well as incremental cost-outcome ratio will be calculated i.e. if the study switches from one
alternative (A) to another alternative (B), the changes in costs and outcomes will be
compared (like, C1 - C0 / E1 - E0). Changes in various effects between intervention and
comparison group will be considered as the changes in outcome/success of the intervention.
The program with the low cost-effectiveness ratio will be considered as cost-effective
intervention as it would offer most value for money.
Data management and analysis:
Data will be entered twice and stored in a relational database. Pre-coded questionnaire will
be used to minimize data coding errors. All data forms and questionnaires will be checked for
errors and necessary corrections will be made before data entry. A data entry program with
built-in range and consistency checks will be used. Frequency distributions will be run to
identify outliers. In all analyses, potential confounding variables and effect modifiers will
be considered. Data will be entered, processed and analyzed using the statistical software
packages SPSS for Windows version 21.0 and Epi Info version 7.0.
Statistical analyses will include descriptive as well as analytical methods. Basic
presentations of data will include number and percentages of individuals with hypertension by
age, sex and in relation to different known risk factors of interest. The descriptive
statistics will be expressed as percentages, means, medians, standard deviations with ranges
or with 95% confidence intervals where appropriate. Chi-square (χ2) tests will be computed to
assess the association between outcome and independent variables. Odds ratios will be
calculated for hypertension after adjusting for major confounding variables (e.g. age, sex,
food habits, socioeconomic status, nutritional status, family history of hypertension etc.).
Effects of interaction terms will also be examined fitting logistic regression models. When
the main outcome measures are continuous variables, the statistical significance of group
mean comparisons will be determined by Student's t-test. The primary analysis will be
intention to treat which will provide relative unbiased comparisons among the intervention
and control groups. In case of non-normal distribution of measurements, equivalent
non-parametric tests will be used. Statistical significance will be defined as p<0.05.
Secondary outcomes will be compared with the χ2 test for categorical outcome. Fisher's exact
test when needed will be performed to estimate p values. For all models, the results will be
expressed as an estimate of effect size, with 95% CIs and p values.
Outcome Variables:
Primary outcomes:
1. 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.
Secondary outcomes:
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.
Ethical Implications:
The study will only be initiated after it has been approved by the Institutional Review Board
(IRB) of Bangladesh Medical and Research Council (BMRC) as well as collaborating institutes
in Bangladesh. Before enrolment, signed informed consent will be obtained from the
participants. The consent form will be written in Bangla in a language and format that will
be easily understood by the study participants of even little education. The consent form
will be read out to the study participants. Signed consent or the left thumb impression will
be obtained from the participants for participation in the study. A copy of the signed
consent form will be given to the participant for their future questions and concerns. There
will be some personal questions (age, income, contact address) for household respondents in
the questionnaires. We will also collect blood and urine samples. So, there are some
precautions will be taken to address the risk. Firstly, field researchers will be careful to
emphasize the voluntary nature of engagement with the study and should ensure that
participants will confirm written consent during the interview. Secondly, the personal
questions will be asked in a calm and sensitive manner. Thirdly, during sample collection as
much as possible we will take higher protection. Finally, total anonymity across all stages
of the study will be maintained and access to raw data will be restricted to researchers only
and stored securely.
