Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04992000 |
Other study ID # |
YDU/2020/76-997 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2020 |
Est. completion date |
December 1, 2020 |
Study information
Verified date |
August 2021 |
Source |
Near East University, Turkey |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study aimed to examine the effects of a public health nursing intervention plus m-Health
applications for hypertension management on enhancing the Self-care, systolic and diastolic
blood pressure, and quality of life in older adults during the lockdown period in Jordan.
Study Hypothesis:
There are no differences between the three groups in:
H01 HTN self-care (SC-HI) score. H02 Health-related quality of life (SF-36) score. H03 The
management of systolic and diastolic BP levels.
Description:
COVID-19 pandemic has affected all health aspects and aggravated chronic diseases health
disparities because it is more common among vulnerable populations such as seniors 1.
Hypertension (HTN) is a long-term chronic disease, affects more than 1 billion people around
the world 2. In Jordan, one-third of Jordanian adults are hypertensive 3, one study expected
that the prevalence of hypertension in 2013 may increase 7.2% by 2030 4, the HTN deaths rate
touched 5% of total deaths, ranks Jordan number 7 in the world, and ranks the HTN at number 6
of leading causes of death, after coronary heart disease and stroke, the first and second
leading causes of death in Jordan 5. If high blood pressure is uncontrolled, HTN is the main
contributor to heart failure, cardiovascular disease, stroke, kidney disease, and death 2.
Concurrent with COVID-19, care is compromised in the context of lockdown and social
distancing. Patients with chronic illness at his time have the risk that they are not
obtaining the necessary hospital care, and alternative solutions are required, such as
improving patient's self-care of his or her chronic disease 6. Since the hospitals are
occupied with COVID-19 cases, the elderly have a perceived threat of COVID-19 and have begun
avoiding or delaying health care follow-up 1. It is essential that the investigators find
innovative solutions and sustainable methods for patients with HTN to control the blood
pressure (BP), enhance self-care, and protect them from COVID-19, and ultimately improve
their quality of life.
Engaging the patient in self-care makes him/her an active participant in the management of
illness 7. Researchers worked to provide patients with the essential knowledge, skills and
abilities to follow treatment recommendations and tolerate blood pressure control 8,9.
Although they agreed that the best ways to prevent and manage high BP are through reasonable
lifestyle changes, i.e., weight loss, low salt diet, stop smoking, limited alcohol, stress
management, exercise, and medication 8, this makes the managing of high BP neither more
difficult, nor easier.
However, to support healthy behaviors, the big electronic revolution provides a good
opportunity to involve patients suffering from HTN in the health care process and self-care
engagement in a safe space 10,11. Moreover, in order to adapt to disruptions during COVID-19,
telehealth, mobile health (m-health), and other technologies which support the self-care
process and facilitate access to care are appropriate approaches to protect vulnerable
populations who are living with chronic diseases 1,12,13. However, improving the self-care of
HTN using m-health is not a new approach; it has been studied previously by researchers from
different disciplines such as technical medicine, family medicine, and pharmacy 14-19, with
less attention given to the nursing role.
In literature, especially nursing literature, there is a lack of sufficient scientific
research on the effectiveness of m-Health, guided by nurse's intervention, on self-care of
HTN, particularly among older adults12,13. Recently, one study provided a nurse-led program
as an example of an effective method to HTN management among older adults 20. The
consequences of the COVID-19 pandemic (isolation, social distancing, quarantine) show major
challenges in provision of care for older adults with chronic illness 1,6. The m-Health
offers a great chance for providing care during the lockdown period, which can be applied via
mobile apps 21. Thus, examining m-Health Apps guided by public health nursing (PHN)
interventions for the management of HTN in older adults during the pandemic can provide
important empirical evidence of effectiveness of such new innovative self-care of HTN
interventional methods.
In this study, the investigators aim to examine three patients outcomes; self-care of HTN,
change of systolic and diastolic of BP, and quality of life in three groups of older adult
patients with HTN: the interventional group (4-free Apps + PHN interventions + education),
control groups 1 (4-free Apps + education), and control group 2 (education) during the
imposition of lockdown in Jordan as a result of COVID-19 pandemic.