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Self-Care of Hypertension Among Older Adults During COVID-19

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
4-free app + PHN intervention
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring self-care, hypertension, COVID-19, m-Health, Older adults

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participants were 55 years and above,
  2. have follow-up with out-patients of KAUH,
  3. had been diagnosed with hypertension,
  4. on anti-hypertension medication- at least one drug,
  5. reported that he/she has a personal smartphone (Android) - internet access is not important,
  6. able to read and understand the Arabic language.

Exclusion Criteria:

  1. Participants have Apple phones,
  2. had any psychiatric or mental illness,
  3. had a terminal-stage disease or were blind or deaf.

Sites / Locations

  • Near east University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

4-free app + PHN intervention

4-free app alone

education

Arm Description

The intervention group was received initial education, 4-free apps, and followed by PHN interventions. Education, app, and PHN intervention

The apps alone group received the initial education and the 4-free Apps.

Standard care group received just the initial education.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 29, 2021
Last Updated
August 5, 2021
Sponsor
Near East University, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT04992000
Brief Title
Self-Care of Hypertension Among Older Adults During COVID-19
Official Title
Self-Care of Hypertension of Older Adults During COVID-19 Lockdown Period: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
self-care, hypertension, COVID-19, m-Health, Older adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-free app + PHN intervention
Arm Type
Experimental
Arm Description
The intervention group was received initial education, 4-free apps, and followed by PHN interventions. Education, app, and PHN intervention
Arm Title
4-free app alone
Arm Type
Experimental
Arm Description
The apps alone group received the initial education and the 4-free Apps.
Arm Title
education
Arm Type
No Intervention
Arm Description
Standard care group received just the initial education.
Intervention Type
Other
Intervention Name(s)
4-free app + PHN intervention
Intervention Description
same mentioned in groups
Primary Outcome Measure Information:
Title
Self-care (SC-HI) scale
Description
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.
Time Frame
basic and after 3 months
Title
Changing in systolic and diastolic blood pressure
Description
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.
Time Frame
basic and after 3 months
Secondary Outcome Measure Information:
Title
Quality of life (SF-36) scale
Description
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.
Time Frame
basic and after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Participants have Apple phones, had any psychiatric or mental illness, had a terminal-stage disease or were blind or deaf.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hatice Bebis, Prof. Dr
Organizational Affiliation
Near East University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Near east University
City
Nicosia
Country
Cyprus

12. IPD Sharing Statement

Citations:
PubMed Identifier
35836287
Citation
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.
Results Reference
derived

Learn more about this trial

Self-Care of Hypertension Among Older Adults During COVID-19

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