Effectiveness and Usability of a Mobile Application to Assist in the Pharmacological and Non-pharmacological Treatment of Arterial Hypertension
Phase: NA
Conditions: Hypertension
Sponsor: Universidade Federal de Santa Catarina

 
 
 
 
 
 
 
Development, effectiveness and usability of a mobile 
application to assist in the pharmacological and non-
pharmacological treatment of arterial hypertension 
RESEARCH PROJECT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FLORIANÓPOLIS 
13/09/2022 
 
 
 

2 Objectives (general and specific): 
 
2.1 General objective 
Develop an application for the two most popular smartphone platforms 
(Google Android and Apple iPhone) aimed at treating SAH, with tools aimed at 
medication adherence, blood pressure monitoring, monitoring and promotion of 
physical activity and lifestyle habits healthy subjects of Brazilians with SAH. 
 
2.2 Specific Objectives 
The specific objectives of the study will be: 
a) develop a prototype application aimed at treating patients with SAH, 
including tools to improve medication adherence, monitor blood pressure values, 
monitor and promote physical activity and healthy lifestyle habits; 
b) test the effectiveness of this application on laboratory systolic and 
diastolic blood pressure, adherence to drug treatment, habitual physical activity 
and lifestyle in hypertensive adults. 
c) test the usability of this application on hypertensive adults. 
 
3 Materials and methods 
 
The study will be developed in three stages, according to the objectives 
outlined. Initially, a prototype of a cellphone application will be developed to help 
Brazilian adults diagnosed with SAH, with tools related mainly to medication 
adherence, promotion of physical activity and monitoring of blood pressure 
values, in addition to health tips (food, smoking, alcoholism and stress 
management). Subsequently, this prototype will be made available to a group of 
adult hypertensive patients so that the effectiveness of this application can be 
tested on laboratory blood pressure values, medication adherence and lifestyle 
aspects, including physical activity and, subsequently, physical activity. 
Application usability will be tested. Subsequently, after making the necessary 
adjustments, the application will be made available on the Apple iTunes and 
Google Play platforms and disseminated in groups of Basic Health Units and in 
the media (advertisements on television, newspaper, radio). From there, the 
number of downloads and the grade assigned to user reviews (one, two, three or 

four stars) will be evaluated, according to the user's sociodemographic 
characteristics (gender, age, place of residence).  
 
App Development 
 
3.1 General Description 
The main focus of the application is to assist in the treatment of patients 
with SAH. The application will address the components of adherence to 
medication use, blood pressure monitoring and promotion/monitoring of physical 
activity. In addition, health education tips will be provided, including guidelines for 
reducing sodium consumption, adopting an adequate and healthy diet, controlling 
body weight, moderate alcohol consumption and stress management, in 
accordance with the recommendations of the main guidelines related to the 
theme 1, 3 . 
After downloading, patients must manually enter demographic data (date 
of birth, sex), their body mass and height, information regarding the use of the 
drugs used, the presence of comorbidities (diabetes, dyslipidemia, chronic kidney 
disease, coronary artery disease, peripheral arterial disease, among others). In 
addition, the user must enter data related to their lifestyle, including information 
about: physical activity, nutrition, alcohol consumption, tobacco use, stress and 
relationships, according to an adapted version of the Fantastic lifestyle.  
Based on this information entered by the patient (input), the application will 
issue reminders: a) for the use of the medication(s), according to the time 
registered by the patient, daily; b) to perform blood pressure measurements. The 
patient will be instructed to take blood pressure measurements while sitting, in a 
calm environment, after five minutes of rest, with the bladder emptied and there 
is at least 30 minutes of abstention from food, cigarettes and/or alcoholic and 
caffeinated beverages. Such measured BP values must be entered in the 
application and, if a BP level above the recommended values is identified, the 
insertion of the importance of the correct use of antihypertensive medication and 
adoption of a healthy lifestyle will increase. It will also be suggested that you 
consult your doctor for possible medication adjustments. 
In addition, the user will be given the possibility to self-monitor their 
physical activities and, based on this information, the application will generate 

feedback informing whether or not the user has reached the recommendations 
currently in force 17, 18. If the user does not meet the recommendations throughout 
the week, illustrative messages or videos will be generated with stimuli and 
guidelines for the patient to increase their level of physical activity, according to 
such recommendations. Illustrative messages or educational videos will also be 
made available with tips on healthy living habits, including recommendations for 
body weight control, reducing sodium consumption, adopting healthy eating 
habits, stress control and smoking cessation, as recommended by the main 
guidelines related to thematic 1, 3. 
Reports for the patient regarding blood pressure values and physical 
activity will be available, showing the evolution over time. For programmers and 
researchers, these same reports will also be generated, in addition to reports with 
application usage statistics and general user characteristics (business 
intelligence), so that, with this information, the system can be feedback. 
 
Patients will be able to designate family members and/or friends to have 
access to the data captured and generated by the application, so that these 
people can provide social support for the treatment of hypertensive patients. In 
addition, a communication channel will be opened between patients that the 
application identifies in closer locations, in case the patient wants to share doubts, 
challenges and achievements. 
 
 
3.2 Effectiveness testing 
 
3.2.1 Participants 
This stage of the study will involve the performance of a randomized and 
controlled clinical trial that will be conducted at the Sports Center of the Federal 
University of Santa Catarina, Florianópolis, SC. Based on a previous behavior 
change study19, taking systolic blood pressure as a reference, taking into account 
an effect size of 0.8, power of 80% and alpha error of 0.05, the estimated sample 
size is 52 participants (26 per group). The recruitment of these participants will 
be based on the dissemination of the research in the local media (radio, 
newspapers, internet) and in social groups, distribution of pamphlets and posting 
of posters in the vicinity of the evaluation sites.  
 

3.2.2 Screening 
As inclusion criteria, participants must be over 18 years old, have a clinical 
diagnosis of SAH³, have been using antihypertensive medication for more than 
three months, and cannot be involved in the regular practice of physical activities. 
In addition, participants must have a smartphone, they must not have cognitive 
disabilities that limit the understanding and use of an application and/or physical 
limitations that make it difficult to practice physical activities. Changes in the type 
and/or dose of antihypertensive drugs used during the study will be considered 
as exclusion criteria. 
 
3.2.3 Randomization 
 
After the pre-intervention assessments, participants will be randomized 
into two groups: app group (GA) and control group (CG). This randomization will 
be performed in blocks, according to sex and pre-intervention blood pressure, 
from a table of random numbers, by researchers who are not directly involved 
with the recruitment of participants and with data collection. 
 
3.2.4 Experimental Design 
Participants will be submitted, before the start of the intervention (pre-
intervention), to laboratory blood pressure assessments, adherence to drug 
treatment, physical activity and lifestyle. Afterwards, the GC will participate in an 
informative lecture on healthy habits and general aspects of SAH control and 
treatment, while the GA will be submitted to the use of the application for eight 
weeks. At the end of these eight weeks of intervention (post-intervention), the 
participants of both groups will be reassessed in all the items analyzed at the pre-
intervention moment. It is noteworthy that the researchers involved with the 
evaluations and data analysis will be blinded regarding the randomization of the 
participants. 
 
3.2.5 Application group 
 
Participants undergoing the GA will be instructed on how to download the 
application and how to use it. From there, all personal data must be entered into 
the application so that alerts, tips and incentives can be issued to each one, 
individually, as described in item 3.1 (application development). 

 
3.2.6 Control group 
The GC, in turn, will participate in a single lecture, in the first week of the 
intervention, with basic guidelines related to the key points of the treatment of 
SAH, including the importance of medication adherence, monitoring of blood 
pressure values and/or capillary glucose, lifestyle modifications linked to physical 
activity, eating habits, smoking cessation, stress management and moderate 
alcohol consumption. 
 
3.2.7 Laboratory blood pressure assessment 
 
The laboratory blood pressure (systolic and diastolic) will be obtained in 
two days, at a similar time, using the OMRON automatic equipment, model 
742HEM. On each day, three measurements will be performed with an interval of 
one minute between them, with the cuff placed on the left arm, elevated to the 
height of the midpoint of the sternum. If the variation of these three 
measurements is greater than 4 mmHg for systolic and/or diastolic blood 
pressure, new measurements will be performed until this established criterion is 
met. The average value between the measurements obtained on the different 
days will be recorded as a reference value at the different moments of the study. 
 
3.2.8 Assessment of medication adherence 
Adherence to the medication will be assessed using the Morisky's 
Therapeutic Adherence Scale of eight items, translated into Portuguese and 
validated by Oliveira-Filho et al.20, in the pre and post-intervention moments. 
 
3.2.9 Assessment of habitual physical activity 
Habitual physical activity will be assessed using accelerometry, using 
devices of the GT3X and GT3X+ models (Actigraph Pensacola, FL, USA) and 
the Actilife software (Actigraph Pensacola, FL, USA). Each participant will be 
instructed to use the accelerometer for seven consecutive days, removing it only 
to sleep, shower or perform water activities. The device will be placed on an 
elastic belt and fixed on the right side of the hip. Data will be collected at a 
frequency of 30 Hz and analyzed in 60 s epochs. Periods with consecutive zeros 
for 60 min or more (with a 2 min tolerance) will be interpreted as non-use time 

and excluded from the analysis 21. For analysis purposes, a minimum of 10 hours 
of daily activity recordings, for at least four days, three weekdays and one 
weekend day will be considered valid data. The average time spent in each 
intensity of physical activity will be calculated from the cut-off points proposed by 
Freedson et al. 22, considering sedentary behavior as 0 – 99 counts/min, light 
physical activities as 100-1951 counts/min, moderate physical activities as ≥ 1952 
counts/min and vigorous or very vigorous activities as ≥ 5725 counts/min. Data 
will be analyzed in min/day, adjusted by number of days of use and daily time of 
use. 
 
3.2.10 Lifestyle assessment 
Lifestyle will be evaluated using an adapted version of the Fantastic 
questionnaire which includes questions related to the following components: 
nutrition, physical activity, preventive behavior, social relationships and stress 
control. For each question, patients will answer whether such behavior is not part 
of their lifestyle, rarely matches, almost always matches, or always matches. 
 
3.2.11 Evaluation and patient satisfaction with the application 
At the end of the intervention, patients undergoing the GA will be invited to 
answer an adapted version of the assessment scale for smartphone applications 
for health care, proposed by Jim and Kim 24, which contains 23 items in total, 
related to the assessment of content, objectivity, interface design, writing style 
and technology, with response options ranging from zero (not at all) to four (a lot), 
generating an overall score. From there, all adjustments that are considered 
relevant will be made so that the final version of the application will be available 
on Apple iTunnes and Google Play. 
 
3.2.12 Statistical analysis plan (SAP) 
Initially, the normality and homogeneity of variance will be analyzed using 
the Shapiro-Wilk and Levene tests, respectively. For data that do not have a 
normal distribution, logarithmic transformation will be performed. Student 's t test 
for independent samples and the chi-square test will be used to compare the 
groups at the pre-intervention moment, regarding continuous and categorical 
variables, respectively. 

For the Intra and inter-group comparisons of quantitative and qualitative 
variables, the method of generalized estimation equations will be used (group: 
GA and GC; time: pre and post-intervention assessments; interaction (group vs. 
time), after confirming the appropriate assumptions. In all analyses, when a 
significant effect is verified, the Newman-Keuls post-hoc test will be used, with a 
P value <0.05 being considered significant. 
 
3.3 Usability and patient satisfaction testing 
After the application is made available on Apple iTunes and Google Play 
and the application is disseminated in groups of Basic Health Units and in the 
media (advertisements on television, newspaper, radio), the number of 
downloads and the grade assigned to user evaluations will be evaluated (one, 
two, three or four stars), according to the sociodemographic characteristics of the 
user (gender, age, place of residence). 
 
3.4 Ethical issues 
This study will be submitted to the Research Ethics Committee of the 
Federal University of Santa Catarina, will follow the rules of Resolution 466/12 of 
the National Health Council on research involving human beings and the stage 
involving the performance of the clinical trial will be registered at 
ClinicalTrials.gov. 
 
 
 
 
 
 
 
 
 
 
 
 
 

FREE AND CLARIFIED CONSENT TERM 
 
Title: DEVELOPMENT, EFFECTIVENESS AND USABILITY OF A MOBILE 
APPLICATION 
TO 
ASSIST 
IN 
PHARMACOLOGICAL 
AND 
NON-
PHARMACOLOGICAL TREATMENT OF ARTERIAL HYPERTENSION 
 
Responsible Researcher: Dr. Aline Mendes Gerage da Silva (CDS/UFSC) 
 
 
You are being invited to voluntarily participate in this study, which is linked to 
the Sports Center of the Federal University of Santa Catarina. If you decide to 
take part in the study, you will need to know the possibilities of risks and benefits 
and confirm your participation through this free and informed consent form. This 
document clarifies the study you wish to participate in. If you have any questions, 
please feel free to contact the team responsible for conducting the study and we 
will clarify your doubts. This research is based on Resolution 466/2012 of the 
National Health Council and the researchers are committed to complying with all 
its items. 
The decision to take part in the study is voluntary and you can refuse or 
withdraw from the study at any time without prejudice. 
 
1. The objective of this research is to analyze the effectiveness of a mobile 
application aimed at drug and non-drug treatment of arterial hypertension on 
systolic and diastolic blood pressure, adherence to drug treatment, habitual 
physical activity and lifestyle in hypertensive adults . 
 
2. Justification: Arterial hypertension is a multifactorial cardiovascular disease, 
which stands out as an important risk factor for the development of other 
cardiovascular diseases, which are the main causes of death in Brazil and in the 
world. Despite the evidence of several effective treatments for arterial 
hypertension, in Brazil, it is estimated that more than half of hypertensive patients 
do not undergo any treatment. Among the possible reasons for this, low 
adherence to the proposed treatment (drug and non-drug) and deficiencies in 
health care systems in approaching the treatment of chronic diseases such as 
hypertension stand out. In this context, in order to improve the control and 
treatment of the disease, the development of innovative methodologies that 
provide strategies to increase adherence to drug treatment and facilitate changes 
in lifestyle are necessary. 
 
3. Experimental Phase Procedures: One of the guardians will explain in detail 
all the procedures that you will undergo when you agree to participate in the 
study, as specified below. 
• Before inclusion in the study, you will be screened in order to identify if you 
fit the profile of our study. You will answer some questions about your age, 
income, medications in use, lifestyle and adherence to drug therapy, as 
well as your blood pressure and your usual level of physical activity will be 
measured. 

• After inclusion in the study, for eight weeks, you will participate in a group 
that will have access to a cell phone application or a control group, which 
will participate in a single lecture, with basic guidelines related to key 
points of the treatment of arterial hypertension, In addition, at the end of 
these eight weeks, you will be evaluated again regarding the medications 
in use, lifestyle and adherence to drug therapy, as well as the measure 
your blood pressure and your usual level of physical activity. 
 
4. Expected Discomfort or Risks: All examinations and tests in this research 
are safe and well tolerated. The collections will be carried out by health 
researchers, experienced and trained for each measure. However, some 
discomforts may occur. In general, you can expect: 
• The blood pressure measurement in the office can generate pain because 
the cuff will keep squeezing the arm, but it is important to emphasize that 
the procedure is very fast (on average 30 seconds for each measurement); 
• Questions related to income, medications in use, lifestyle and adherence 
to medication therapy may cause you embarrassment, however you have 
the right not to answer any questions you are not comfortable with. ; 
• Monitoring your physical activity can cause discomfort, as you will have to 
remember whenever possible to attach a small monitor (accelerometer) to 
your waist, not forgetting to take it off when you go to sleep or when you 
shower or when perform any water activity. 
 
As they are health professionals, in case of eventual complications that may arise 
at the time of collection, the researchers will take the necessary measures to 
stabilize the patient. 
 
5. Expected benefits: The data used in this research will help to know if the 
application under test improves blood pressure and adherence to drug and non-
drug treatment (lifestyle changes) of hypertensive patients on a daily basis. In 
addition, by participating in the project, you will have an assessment of various 
parameters of your health that will be made available whenever you want. 
 
6. Withdrawal of Consent: You may withdraw your consent and withdraw from 
participating in the research at any time, without prejudice. 
 
7. Guarantee of Confidentiality and Indemnity: The information obtained in 
this research will be analyzed together with that of other patients, and their 
identification will not be disclosed at any time. However, it is important to inform 
that there is a remote possibility of an involuntary and unintentional breach of 
confidentiality of the participants (for example, loss or theft of documents, 
computers, software, flash drive ) and, in this situation, the consequences will be 
dealt with under the terms of the law. You may, at any time, have access to the 
information contained in this statement or to any other information you wish about 
this study, including the results of your exams. There are no costs for you related 
to the exams, consultations of this project. The research team guarantees the 
reimbursement of possible personal expenses arising from participation in this 
study. There is also no financial compensation related to your participation. If 
there is any additional expense related to the experimental procedures, the 
research team will make the corresponding reimbursement. The data collected 

will be used exclusively for the purposes of this research. In addition, in the event 
of any material or immaterial damage resulting from the research, you will be 
entitled to compensation as recommended by the current resolution. 
 
8. The Research Ethics Committee (CEP) is an interdisciplinary and 
independent collegiate, which must exist in institutions that carry out research 
involving human beings in Brazil, created to defend the interests of research 
participants in their integrity and dignity and to contribute to the development of 
research within ethical standards (Regulatory Norms and Guidelines for 
Research involving Human Beings – Res. CNS nº 466/12). The CEP is 
responsible for the evaluation and monitoring of research protocols in terms of 
ethical aspects. 
 
• Address of the CEP of the Federal University of Santa Catarina: 
Rectory Building II R: Desembargador Vitor Lima, nº 222, room 401, 
Trindade, Florianópolis/SC. CEP 88.040-400. Contact: (48) 3721-6094. 
E-mail: cep.propesq@contato.ufsc.br 
 
After these clarifications, we ask for your consent to participate in this research. 
Two copies of this document were prepared and will be initialed and signed by 
you and the researcher in charge, and one of these duly signed copies will remain 
with you. 
  
At any stage of the study, you will have access to the professionals responsible 
for the research for clarification of doubts. 
 
9. Post-Information Consent: 
 
I, ________________________________________________, after reading 
and understanding and discussing this information and consent form, understand 
that my participation is voluntary, and that I can withdraw from the study at any 
time, without prejudice. I confirm that I have received a copy of this consent form, 
and I authorize the carrying out of the research work and the dissemination of 
the data obtained only in this study in the scientific environment. 
 
 
 
________________________________________ 
Participant's Signature 
 
Date: ____/____/_______ 
 
 
10. 
I, 
________________________________________ 
(responsible 
researcher), certify that: 
 
a) Research ethics implies respect for human dignity and the protection due to 
participants in scientific research involving human beings; 

b) This study has scientific merit and the team of professionals involved is 
trained, qualified and competent to perform the procedures described in this 
term; 
c) This research is based on Resolution 466/2012 of the National Health Council 
and the researchers are committed to complying with all its items. 
 
 
 
______________________________ 
Dr. Aline Mendes Gerage (UFSC) 
Tel : (48) 3721-3860 
email: alinegerage@yahoo.com.br 
Address: Rua Coronel Luiz Caldeira, nº 105, apto 101b, Itacorubi, Florianópolis 
– SC.