HypertensionNCT04992000
Self-Care of Hypertension Among Older Adults During COVID-19
A study testing 4-free app + PHN intervention in people with Hypertension, run by Near East University, Turkey at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- 4-free app + PHN intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jun 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants were 55 years and above,
- have follow-up with out-patients of KAUH,
- had been diagnosed with hypertension,
- on anti-hypertension medication- at least one drug,
- reported that he/she has a personal smartphone (Android) - internet access is not important,
- able to read and understand the Arabic language.
Who cannot join
- Participants have Apple phones,
- had any psychiatric or mental illness,
- had a terminal-stage disease or were blind or deaf.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Care of Hypertension of Older Adults During COVID-19 Lockdown Period: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Hypertension
- Being tested
- 4-free app + PHN intervention
- Keywords
- self-care, hypertension, COVID-19, m-Health, Older adults
- Medical subject headings
- Hypertension, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-free app + PHN interventionOther
same mentioned in groups
| Study group | Role | What they receive |
|---|---|---|
| 4-free app + PHN intervention | Experimental | The intervention group was received initial education, 4-free apps, and followed by PHN interventions.
Education, app, and PHN intervention Receives: Other: 4-free app + PHN intervention |
| 4-free app alone | Experimental | The apps alone group received the initial education and the 4-free Apps. Receives: Other: 4-free app + PHN intervention |
| education | No intervention | Standard care group received just the initial education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care (SC-HI) scale
Self-care of HTN was measured by the SC-HI scale, which developed to measure the self-care in patients with HTN 26. SC-HI has the ability of evaluate the effectiveness of such self-care interventions. SC-HI is 23-item in three subscales: measuring self-care maintenance, monitoring, and management, Cronbach's α were 0.83, 0.75, and 0.83 for the three subscales. For the purpose of this study, authors cross-culturally translated the scale into Arabic in a previous study; Cronbach's α were 0.82, 0.61, and 0.86 for the three subscales 27. . Each subscale is scored distinctly and identical from 0 to 100, the final score calculated as: (the participant score - minimum) / (maximum - minimum) * 100. The separate score 70 or greater is indicated better self-care.
Measured: basic and after 3 months
Changing in systolic and diastolic blood pressure
Systolic BP (SBP) and diastolic BP (DBP) were measured and recorded by a clinic nurse who has 9 years' experience in the cardiac clinic two times for the purpose of study's analysis; at baseline and after 3 months following the same assessment process: Patients in setting position with their arms at the chest line, relaxed for 5 minutes, then measuring the BP of the right arm using an electronic sphygmomanometer which was checked for calibrated regularly. BP readings through the 3 months were measured by patients themselves at home.
Measured: basic and after 3 months
Secondary outcomes (1)
Quality of life (SF-36) scale
Quality of life (QOL) of hypertensive patients was measured using the 36-Item Short Form Survey (SF-36). SF-36 questionnaire has been used as health indicator to screen the health status of persons and evaluate the health interventions 28. The questionnaire has the feasibility to be administered as a self-report, personal interview or by telephone, and takes 5-10 minutes to complete. SD-36 included 8 subscales: physical functioning (PF), bodily pain, role limitations due to physical health problems (RF), role limitations due to personal or emotional problems (RE), emotional well-being (EW), social functioning (SF), energy/fatigue (EF), and general health perceptions 28. SF-36 was frequently used to measure QOL in older adults with hypertension; the Arabic version was used in studies with Cronbach's α ≥ 0.70 29,30.
Measured: basic and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jun 2020
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khitam Alsaqer, Near East University, Turkey
- Investigators
- hatice Bebis, Prof. Dr, Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992000
- Sponsor's protocol ID
- YDU/2020/76-997
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alsaqer K, Bebis H. Self-care of hypertension of older adults during COVID-19 lockdown period: a randomized controlled trial. Clin Hypertens. 2022 Jul 15;28(1):21. doi: 10.1186/s40885-022-00204-7.
PubMed 35836287
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Care of Hypertension of Older Adults During COVID-19 Lockdown Period: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04992000
- Acronym / sponsor ID
- YDU/2020/76-997
- Conditions
- Hypertension
- Keywords
- self-care, hypertension, COVID-19, m-Health, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-free app + PHN intervention | Experimental | Other: 4-free app + PHN interventionThe intervention group was received initial education, 4-free apps, and followed by PHN interventions. Education, app, and PHN intervention |
| 4-free app alone | Experimental | Other: 4-free app + PHN interventionThe apps alone group received the initial education and the 4-free Apps. |
| education | No intervention | –Standard care group received just the initial education. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants were 55 years and above,
- have follow-up with out-patients of KAUH,
- had been diagnosed with hypertension,
- on anti-hypertension medication- at least one drug,
- reported that he/she has a personal smartphone (Android) - internet access is not important,
Key exclusion criteria (3 listed)
- Participants have Apple phones,
- had any psychiatric or mental illness,
- had a terminal-stage disease or were blind or deaf.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-free app + PHN interventionsame mentioned in groups | Other | 4-free app + PHN intervention, 4-free app alone |
Primary outcome
Self-care (SC-HI) scale
Time frame: basic and after 3 months
Self-care of HTN was measured by the SC-HI scale, which developed to measure the self-care in patients with HTN 26. SC-HI has the ability of evaluate the effectiveness of such self-care interventions. SC-HI is 23-item in three subscales: measuring self-care maintenance, monitoring, and management, Cronbach's α were 0.83, 0.75, and 0.83 for the three subscales. For the purpose of this study, authors cross-culturally translated the scale into Arabic in a previous study; Cronbach's α were 0.82, 0.61, and 0.86 for the three subscales 27. . Each subscale is scored distinctly and identical from 0 to 100, the final score calculated as: (the participant score - minimum) / (maximum - minimum) * 100. The separate score 70 or greater is indicated better self-care.
Changing in systolic and diastolic blood pressure
Time frame: basic and after 3 months
Systolic BP (SBP) and diastolic BP (DBP) were measured and recorded by a clinic nurse who has 9 years' experience in the cardiac clinic two times for the purpose of study's analysis; at baseline and after 3 months following the same assessment process: Patients in setting position with their arms at the chest line, relaxed for 5 minutes, then measuring the BP of the right arm using an electronic sphygmomanometer which was checked for calibrated regularly. BP readings through the 3 months were measured by patients themselves at home.
1 secondary outcome
Quality of life (SF-36) scale
Time frame: basic and after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 35836287Alsaqer K, Bebis H. Self-care of hypertension of older adults during COVID-19 lockdown period: a randomized controlled trial. Clin Hypertens. 2022 Jul 15;28(1):21. doi: 10.1186/s40885-022-00204-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hatice Bebis, Prof. Dr principal investigator
Near East University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-free app + PHN intervention in people with Hypertension, run by Near East University, Turkey at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care (SC-HI) scale (time frame: basic and after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04992000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.