Effectiveness of a mHealth intervention on hypertension control in a low-resource rural setting: A randomized clinical trial

Abstract

BackgroundDespite the increasing popularity of mHealth, little evidence indicates that they can improve health outcomes. Mobile health interventions (mHealth) have been shown as an attractive approach for health-care systems with limited resources. To determine whether mHealth would reduce blood pressure, promote weight loss, and improve hypertension compliance, self-efficacy and life quality in individuals with hypertension living in low-resource rural settings in Hubei, China.MethodsIn this parallel-group, randomized controlled trial, we recruited individuals from health-care centers, home visits, and community centers in low-resource rural settings in Hubei, China. Of 200 participants who were screened, 148 completed consent, met inclusion criteria, and were randomly assigned in a ratio of 1:1 to control or intervention. Intervention group participants were instructed to use the Monitoring Wearable Device and download a Smartphone Application, which includes reminder alerts, adherence reports, medical instruction and optional family support. Changes in the index of Cardiovascular health risk factors from baseline to end of follow-up. Secondary outcomes were change in hypertension compliance, self-efficacy and life quality at 12 weeks.ResultsParticipants (n = 134; 66 in the intervention group and 68 controls) had a mean age of 61.73 years, 61.94% were male. After 12 weeks, the mean (SD) systolic blood pressure decreased by 8.52 (19.73) mm Hg in the intervention group and by 1.25 (12.47) mm Hg in the control group (between-group difference, −7.265 mm Hg; 95% CI, −12.89 to −1.64 mm Hg; P = 0.012), While, there was no difference in the change in diastolic blood pressure between the two groups (between-group difference, −0.41 mm Hg; 95% CI, −3.56 to 2.74 mm Hg; P = 0.797). After 12 weeks of follow-up, the mean (SD) hypertension compliance increased by 7.35 (7.31) in the intervention group and by 3.01 (4.92) in the control group (between-group difference, 4.334; 95% CI, 2.21 to −6.46; P < 0.01), the mean (SD) hypertension compliance increased by 12.89 (11.95) in the intervention group and by 5.43 (10.54) in the control group (between-group difference, 7.47; 95% CI, 3.62 to 11.31; P < 0.01), the mean (SD) physical health increased by 12.21 (10.77) in the intervention group and by 1.54 (7.18) in the control group (between-group difference, 10.66; 95% CI, 7.54–13.78; P < 0.01), the mean (SD) mental health increased by 13.17 (9.25) in the intervention group and by 2.55 (5.99) in the control group (between-group difference, 10.93; 95% CI, 7.74 to 14.12; P < 0.01).ConclusionsAmong participants with uncontrolled hypertension, individuals randomized to use a monitoring wearable device with a smartphone application had a significant improvement in self-reported hypertension compliance, self-efficacy, life quality, weight loss and diastolic blood pressure, but no change in systolic blood pressure compared with controls.

Effectiveness of digital health interventions on blood pressure control, lifestyle behaviours and adherence to medication in patients with hypertension in low-income and middle-income countries: a systematic review and meta-analysis of randomised controlled trials

“…From the 22 studies, 12,892 participants from 12 countries were included and published from 2012 to 2023. 8 , 9 , 10 , 11 , 12 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 Most studies (n = 10) were conducted in China, 10 , 11 , 23 , 24 , 25 , 28 , 29 , 30 , 34 , 37 and (n = 2) in Iran. 32 , 33 One study each was conducted in South Africa, 8 Bangladesh, 9 Pakistan, 22 Nepal, 12 Cameroon, 26 Honduras and Mexico, 27 Brazil, 35 Turkey, 36 Russia, 38 and Argentina.…”

“…32 , 33 One study each was conducted in South Africa, 8 Bangladesh, 9 Pakistan, 22 Nepal, 12 Cameroon, 26 Honduras and Mexico, 27 Brazil, 35 Turkey, 36 Russia, 38 and Argentina. 31 Fifteen studies were conducted in upper-middle-income economies (UMIEs), 8 , 10 , 11 , 23 , 24 , 25 , 28 , 29 , 30 , 31 , 34 , 35 , 36 , 37 , 38 and 7 in lower-middle-income economies (LMIEs), 9 , 12 , 22 , 26 , 27 , 32 , 33 according to the World Bank classification. 39 Only RCT articles were considered, with 14 employing a matching design, 3 a cluster, and 5 prospective.…”

“…39 Only RCT articles were considered, with 14 employing a matching design, 3 a cluster, and 5 prospective. A total of 12 studies adopted SMS as the main method for the provision of digital health intervention, 8 , 9 , 12 , 22 , 24 , 25 , 29 , 31 , 32 , 35 , 36 , 37 8 used smartphone apps (apps installed on smartphones), 10 , 11 , 23 , 28 , 30 , 33 , 34 , 38 and 2 used mobile phone calls. 26 , 27 The period of the intervention varied from 1.5 to 18 months, less than 12 months in 19 studies (83.3%), 9 , 10 , 11 , 12 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 32 , 33 , 34 , 35 , 36 , 38 and 12 months and more in 3 studies (16.7%), 8 , 31 , 37 ( Table 1 and Supplementary File, Table S3 on pages 17–18 ).…”

“…Nineteen studies (n = 12,418 participants) were included in the meta-analysis, 8 , 9 , 10 , 11 , 12 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 34 , 36 , 37 , 38 and 5 out of 19 were measured as having a high risk of bias. 8 , 11 , 22 , 24 , 28 Two studies reported two interventions against the same outcome assessed.…”

“… The adherence rate to antihypertensive medications was 49% (intervention) and 12% (control) mHealth effective for BP control Zhai et al., 2020 29 ; China; CG: 192 IG: 192 Cluster RCT; 3 months; SMS Personal consultations by trained pharmacy students; SMS every 3 days; intervention group and control group were given standard pharmaceutical care according to the Guidelines for Good Pharmacy Practice Δ SBP −11.5 mm Hg (intervention) and −9.2 mm Hg (control; p < 0.0001); Δ DBP −0.3 mm Hg (intervention) and −2.7 mm Hg (control; p = 0.06); BP Control 56% (intervention) and 44% (control; p = 0.03). 8-item MMAS score for intervention (7.4 ± 1.2) and control (7.0 ± 1.3, p = 0.04); knowledge score 0.44 (p < 0.0001); Satisfaction with BP control change 70% mHealth effective for BP control Yuting et al., 2023 30 ; China; CG: 68 IG: 66 RCT; 3 months; Smartphone app Smartphone application to receive information about hypertension and health promotion, a home-based BP monitor wearable wristband that stored and uploaded BP data to a secure website via Bluetooth. Δ SBP −8.5 mm Hg (intervention) and −1.3 mm Hg (control); Δ DBP −0.4 mm Hg (intervention) and −0.01 mm Hg (control) Δ WC (intervention vs. control AMD −1.8, p < 0.0001); Δ HC (intervention vs. control AMD −0.3, p = 0.08); hypertension compliance (intervention vs. control AMD 3.9, p < 0.0001); self-efficacy (intervention vs. control AMD 7.9, p < 0.0001); physical health, (intervention vs. control AMD 10.5, p < 0.0001); mental health, (intervention vs. control AMD 10.9, p < 0.0001) mHealth effective for BP control He et al., 2017 31 ; Argentina; CG: 648 IG: 709 Cluster RCT; 18 months; SMS Community health worker-led home-based intervention (health coaching and home BP monitoring and audit), physician education and BP feedback, and individualized weekly SMS to promote lifestyle changes and reinforce medication adherence Δ SBP −19.3 mm Hg (intervention) and −12.7 mm Hg (control; p < 0.0001); Δ DBP −12.2 mm Hg (intervention) −6.9 mm Hg (control; p < 0.0001) The proportion of controlled hypertension was 73% (intervention) and 52% (control); adherence to antihypertensive medication was 66% (intervention) and 53% (control) mHealth effective for BP control Maslakpak et al., 2016 32 ; Iran; CG: 41 IG1: 41 IG2: 41 RCT; 3 months; SMS Two intervention groups (SMS and reminder cards) provide a relationship with patients and remind them to take their medication; control (no intervention) Data on BP not reported Adherence to treatment for SMS (57.7 ± 2.8), and reminder cards (57.5 ± 2.7) vs. control (46.6 ± 3.0) (p < 0.0001).…”