Study design
This study is three-arm groups, single-blind; a randomized controlled trial design was carried out between June and September 2020 in King Abdullah University Hospital (KAUH) in Jordan. KAUH is the largest medical structure in the north of Jordan, serving about 1 million residents [22]. KAUH is a teaching hospital affiliated with Jordan University of Science and Technology. KAUH has an operating capacity of 678 beds, and it can be expanded to 819 beds in emergency situations [23]. In addition, KAUH had received COVID-19 cases in its intensive care unit during the period when the study was conducted.
Study sample
Sample size
G*Power (Heinrich-Heine-Universitat Dusseldorf, Dusseldorf, Germany; http://www.gpower.hhu.de/) was used to calculate the sample size, to achieve a power of 80% at effect size convenient P = 0.30, and alpha error probability 0.05; a total sample size of 93 participants was required. Accordingly, for the probability of attrition to follow-up and study withdrawal, the total sample size was estimated to be n = 120 for the entire study.
Inclusion and exclusion criteria
Participants were enrolled in the study if they were (1) 55 years and above, (2) have follow-up as out-patients of KAUH, (3) had been diagnosed with HTN, (4) on anti-HTN medication—at least one drug, (5) reported that he/she has a personal smartphone (Android)—internet access is not important, and (6) able to read and understand the Arabic language. Participants were excluded if they have Apple smartphones, reported inability to use apps, had any psychiatric or mental illness, had a terminal-stage disease, or were blind or deaf.
Recruitment and participants
Once Jordan opened the vital services after the imposition of the lockdown on June 1, 2020, the researcher contacted the medical records department in KAUH and got a list for patients who had an appointment during June (1 June to 30 June) in out-patient clinics. The list included 1500 patients and they were screened to the initial inclusion criteria: age, HTN diagnoses, and free of mental or multiple chronic illnesses as evidences in the electronic system of the hospital.
Recruited patients (n = 443) were asked via telephone if they would participate in the study, after ensuring they could deal with smartphones and met our inclusion criteria. Patients fit for the study aim went through a systematic random sampling to select the sample (n = 120). The researcher divided the entire population size by 120 to calculate the sampling interval. The starting point was assigned by the drawing of lots method, and then participants were selected every third interval (Fig. 1).
Randomization and blinding
The patients (n = 120) were randomly assigned to either intervention group (n = 40), apps alone group (n = 40), or standard group (n = 40) by the simple random sampling method using randomly generated numbers (ratio 1:1:1). Patients and the research coordinator were aware of the groups. However, the principal investigator, co-investigators, and study statistician were blinded.
The 4-free apps
Free smartphone apps in android were searched through the Play store using keywords such as: self-care, BP, pill reminder, breath, stress management, exercise, and steps. The first 10 pages on the Play store were checked to meet our criteria: free download, English/Arabic language, history availability, and attractiveness in style and colors. The researcher vainly attempted to find an app that included the four main HTN self-care aspects: checking BP, exercise, medication adherence, and stress management. So rather than using one app, the researcher chose one app to help in maintaining and monitoring each one of HTN self-care critical features. While that was not available, the researchers selected one mobile app for each of the four main HTN aspects were (1) My heart (BP), (2) Pill reminder (medication tracker with alarm), (3) Breathe easy, and (4) StepsApp.
The 4-free apps were evaluated for content validity, accessibility, usability, and feasibility by focus group interviews and a committee of experts: two nurses with PhDs, two computer technicians, and one cardiologist. They were asked to evaluate the four selected free apps by rating each app from 1 to 4: 1, not relevant; 2, somewhat relevant; 3, quite relevant but needs minor changes; and 4, very relevant. After calculating the content validity index, the 4-free apps were scored ≥0.80 and that was considered acceptable.
Pilot study
Fifteen patients who are met the study inclusion criteria were enrolled to be in the pilot study. Patients were selected convenes at the intermediate cardiac unit in KAUH, they were interviewed individually in their rooms during hospitalization for 15 min by the researcher, following all COVID-19 protections measures. The researcher presented the education part of self-care of HTN using her personal tap for PowerPoint presentation including pictures. Then, the researcher downloads the four m.apps of self-care of HTN for each participant in his/her phone, saves the 4-apps on quick access mobile screen, and teaches them how to open, follow, and save their data. All patients were evaluated for their understating to education content and acceptance, usability, and feasibility for the 4-selected apps. Almost all patients understand and expressed approval for the 4-free android apps.
Intervention group
The intervention group was received initial education, 4-free apps, and followed by PHN interventions.
Education
Education followed, as per World Health Organization and American Heart Association recommendations for HTN self-care [2]. Subjects: What is high BP; Know your number; How to use a home BP monitor; Choosing a home BP monitor; Changes that patients can make to manage high BP (low salt diet, exercise, medication adherence, stress management, stop smoking, etc.); Educate family members to be part of the BP control process and provide their patient daily reinforcement. Education session presented as well as in the pilot study.
The 4-free apps
Participants were instructed to download and use the 4-free apps to facilitate the self-monitoring and detect BP and behavior changes; encourage patients to incorporate them in their life: encourage self-monitoring of BP, and record their readings in the apps’ history through Myheart-App, encourage adherence to medication using Pill reminder-App, encourage deep breathing exercise as a stress management method using Breathe easy-App, and encourage walking and counting steps daily through Steps-App. The training session was applied as well as in the pilot study.
PHN intervention
Patients were followed via telephone (individual voice calling) for a maximum of 10 min, once weekly; over 3 months by a nurse who is a Ph.D. in PHN and with 7 years’ experience in a cardiac unit. Moreover, the participants continuously can use the chat via a WhatsApp group. The PHN nurse used the three prevention levels (primary, secondary, and tertiary) to guide patients in the self-care process (maintenance, monitoring, and management). The nurse followed the general approaches: (1) assess patient’s maintenance knowledge, attitudes, beliefs, and practices; (2) check the apps’ history for the previous week to detect any changes; (3) and evaluate the patient’s action at that time; (4) finally, give supportive feedback and schedule for next appointment before patient hang up. However, the patients were keeping in touch and sharing their experiences over the three months via the WhatsApp group (e.g., send a screenshot for each app history weekly).
Accordingly, patients were encouraged each other and the PHN nurse provided appropriate interventions based on patients’ needs, which included education, follow-up, screening, counseling, referral, and collaboration with other professionals.
Apps alone group
Apps alone group received the initial education and the 4-free apps.
Standard care group
Standard care group received just the initial education.
Data collections
Demographics data
A self-report questionnaire was prepared literally based on such studies which examined such self-care interventions for HTN patients [14, 17, 18, 24, 25]. The 13 questions were on age, sex, marital status, education, economic status, health insurance, smoking, caregiver, job, family history of HTN, health applications experience, duration of diagnosed with HTN, and the number of antihypertensive medication.
Changing in systolic and diastolic blood pressure
SBP and DBP were measured and recorded by a clinic nurse who has 9 years’ experience in the cardiac clinic two times for the purpose of the 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 min, then measured 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.
Self-care scale
Self-care of HTN was measured by the Self Care of Hypertension Inventory (SC-HI), which was developed to measure self-care in patients with HTN [26]. SC-HI has the ability to 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. A separate score of 70 or greater is indicated better self-care.
Quality of life scale
QoL of hypertensive patients was measured using the 36-Item Short Form Survey (SF-36). SF-36 questionnaire has been used as a 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 min to complete. SD-36 included eight 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 HTN; the Arabic version was used in studies with Cronbach’s α ≥ 0.70 [29, 30].
Data analysis
IBM SPSS ver. 25.0 (IBM Corp., Armonk, NY, USA) was used to perform the statistical analysis. Descriptive statistics were used as mean; standard deviation, minimum, and maximum for continuous variables; frequencies with percentages for categorical variables. Homogeneity of variance at baseline was evaluated using either chi-square or t-test for means differences and frequencies. Normal distribution was tested using the Kolmogorov-Smirnov test; to determine using a parametric or non-parametric test, at 95% confidence interval and a P-value of ≥0.05 was considered statistically significant.
Comparisons between the means before and after within group for the three measures of the study were carried out using a paired-samples t-test or Wilcoxon test, a statistical significance was set as P-value < 0.05. Comparison between groups after 3 months was carried out using either one-way repeated measures ANOVA or the Kruskal-Wallis test followed by Tukey multiple comparisons to identify the individual difference.