Table 1 Study design and baseline characteristics of randomized controlled trials of digital therapeutic intervention for hypertension
Author (year); country | Sample size, n | Age (year) | Setting | Study population | Other diseases | BP Change as Primary Outcome | SBP/DBP at Baseline | Outcomes | Duration | Intervention | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
SBP | DBP | Primary | Secondary | 1 | 2 | 3 | 4 | ||||||||
Stephen D Persell (2020); USA [24] | 333 | 58.9 (12.8) | primary care clinics | Uncontrolled HT | Asthma or COPD, diabetes, coronary heart disease, stroke, heart failure | Yes | 140.6 ± 12.2 mmHg (intervention) 141.8 ± 13.4 mmHg (control) | 89.4 ± 8.7 mmHg (intervention) 89.2 ± 9.2 mmHg (control) | ▲SBP −8.3 ± 13.8 mmHg (intervention), −6.8 ± 13.7 mmHg (control), intervention vs. control, p = 0.16; ▲DBP-4.3 ± 84 mmHg (intervention), −3.6 ± 9.5 mmHg (control), intervention vs. control p = 0.61；▲Rates of controlled BPa 72 (50.0%, intervention), 78 (51.3%, control) | ▲Self-reported physical activity (at least moderate exercise) 26.7 min/week (−5.4, 58.8), p = 0.10; ▲Mean self-confidence in controlling BP score (5-point scale) 0.36 (0.18, 0.54), p < 0.001 | 6mo | ✓ | ✓ | ✓ | |
231 | 55.4 (9.5) | hospital | Uncontrolled HT + AM | Diabetes | No | 143.7 ± 11.4 mmHg (all) 143.5 ± 11.4 mmHg (intervention) 144.5 ± 11.3 mmHg (control) | 89.6 ± 8.1 mmHg (all) 89.2 ± 8.0 mmHg (intervention) 91.3 ± 8.1 mmHg (control) | ▲Weight(kg) RR = −0.39 (−1.49, 0.70); ▲No smoking RR = 0.99 (0.92,1.07); ▲Physical activity ≥ 150 min/week RR = 1.21 (1.03, 1.42); ▲Moderate or no alcohol intake ≤100 g (women)/≤200 g(men)/week RR = 1.12 (1.00, 1.25); ▲ Following ≥ two of six dietary recommendations RR = 1.22 (1.04, 1.42) | ▲Body fat mass between-groups difference −4.05 kg (−8.14, −0.03), intervention vs. control p = 0.052; ▲BMI between-groups difference −1.56 kg/m2 (−3.49, −0.37), intervention vs. control p = 0.113; ▲Waist circumference between-groups difference −4.36 cm (−8.81, −0.082), intervention vs. control p = 0.054 | 6mo | ✓ | ✓ | |||
Yue Ma (2022); China [28] | 210 | 60.6 (10) | community health service centers | HT + AM | Heart disease, diabetes, arthritis, cervical spondylosis, stroke, herniated lumbar discs | Yes | 149.7 ± 12.36 mmHg (intervention) 150.59 ± 11.09 mmHg (control) | 93.77 ± 7.4 mmHg (intervention) 93.25 ± 7.11 mmHg (control) | ▲SBP-11.74 ± 14.34 mmHg (intervention), −1.01 ± 11 mmHg (control), intervention vs. control p = 0.005; ▲DBP −5.53 ± 4.95 mmHg (intervention), 1.69 ± 5.14 mmHg (control), intervention vs. control p = 0.005; ▲Proportion of participants with controlled BPa−17.14% (intervention), −1.15% (control), p = 0.145 | ▲Body weight group*time interaction effect between groups −1.71 kg (−2.23, −1.18), p = 0.0005; ▲BMI group*time interaction effect between groups −0.59 kg/m2 (−0.77, −0.41), p = 0.0005; ▲Waist circumference group*time interaction effect between groups −3.19 cm (−3.79, −2.58), p = 0.0005; ▲The self-care behavior, motivation and self-efficacy (possible range 0–80) (behavior: MD = 6.38, p < 0.001; motivation: MD = 5.85, p < 0.001; self-efficacy: MD = 7.13, p < 0.001) | 3mo | ✓ | ✓ | ✓ | |
390 | 52.4 (8.1) 52.0 (7.6) | hospital | HT + non- AMb | Dyslipidemia, diabetes mellitus, proteinuria, nonvalvular atrial fibrillation | YES | 144.9 ± 10.4 mmHg (intervention) 144.3 ± 10.4 mmHg (control) | 95.0 ± 8.2 mmHg (intervention) 94.3 ± 7.2 mmHg (control) | ▲24 h ambulatory SBP −4.9 ± 16.34 mmHg (intervention), −2.5 ± 20.61 mmHg (control), intervention vs. control, p = 0.024 | ▲ Morning home SBP −4.3 mmHg (−6.7, −1.9), intervention vs. control p < 0.001; ▲Evening home SBP −3.3 mmHg (−5.8, −0.7), intervention vs. control p = 0.013; ▲ Office SBP −3.6 mmHg (−6.2, −1.0), intervention vs. control p = 0.006; ▲ Reductions from baseline in ambulatory, home and office DBP and heart rate were also significantly greater in the DTx and control group; ▲Proportion of morning home BP < 135/85 mmHg 22.2% (intervention), 10.4% (control) | 3mo | ✓ | ✓ | ✓ | ||
56 | 46.5 (9.9) | hospital | Uncontrolled HT + AM | Diabetes | Yes | 152.3 mmHg (intervention) 150.7 mmHg (control) | 86.8 mmHg (intervention) 84.6 mmHg (control) | ▲SBP-31.1 mmHg (intervention), −11.8 mmHg (control), intervention vs. control, p < 0.01; ▲DBP −12.6 mmHg (intervention),−5.2 mmHg (control), intervention vs. control p < 0.01; ▲Percentage of SBP < 140 mmHg −14.4% (intervention), −15.6% (control), p = 0.009; ▲Percentage of DBP < 90 mmHg −38.5% (intervention), −30.5% (control), p = 0.145 | ▲Medication adherencec 0.49 (SMASH), 3.39 (control), SMASH vs. control p < 0.001 | 6mo | ✓ | ||||
McManus RJ (2020); UK [18] | 553 | 66 (10.2) | clinics | Uncontrolled HT + AM | NO | Yes | 151.7 ± 11.8 mmHg (intervention) 151.6 ± 11.1 mmHg (control) | 86.4 ± 9.6 mmHg (intervention) 85.3 ± 9.9 mmHg (control) | ▲SBP −13.3 ± 9.65 mmHg (intervention), −9.79 ± 10.34 mmHg (control), intervention vs. control p < 0.05；▲DBP −6.2 ± 6.24 mmHg (intervention), −5.5 ± 6.32 mmHg (control), intervention vs. control p < 0.05 | ▲Weight loss 29/243 (11.9%, intervention), 57/251 (22.7%, control), p = 0.002; ▲Dose changes in AM RR = 2.0 (1.5, 2.7); ▲Type changes in AM RR = 1.5 (1.1,1.9); ▲MA p = 0.97; ▲Patient enablement difference in PEId −0.4 (−0.5, −0.2) | 12mo | ✓ | ✓ | ✓ | |
Frauke Leupold (2023); German [31] | 525 | 59.4 (9.7) | clinics | Uncontrolled HT + AM | NO | Yes | 156.9 ± 14.8 mmHg (all) 157.8 ± 16.2 mmHg (intervention) 155.9 ± 13.1 mmHg (control) | 93.7 ± 9.6 mmHg (all) 94.8 ± 9.8 mmHg (intervention) 92.5 ± 9.3 mmHg (control) | ▲SBP −22.5 ± 10.37 mmHg (intervention), −13.9 ± 10.87 mmHg (control), intervention vs. control p < 0.05; ▲DBP −10.5 ± 6.13 mmHg (intervention), −9.2 ± 6.41 mmHg (control), intervention vs. control p < 0.05；▲ Proportion of BP target rangea 62.6% (intervention), 44.6%(control), p < 0.001 | ▲ Number of inpatient treatments 23 (8.7%, intervention), 35 (13.5%, control), p = 0.1; ▲Number of serious cardiovascular events (hospitalizations)e 12(4.5%, intervention), 9 (3.5%, control), p = 0.14; ▲Patients’ satisfaction with BP treatment 89.4% (intervention), 79.5% (control), p < 0.001; ▲Number of antihypertensives 0.33 (intervention), 0.15 (control), p = 0.37 at baseline, p = 0.001 at follow up; ▲Utilization of PIA-ICTf 10.59 ± 11.25 (min-max 0–48) medication plans were transferred to patients; 249.79 ± 228.90 (min-max 0–1138) blood pressure readings were transmitted from patients to practices; 3.71 ± 7.95 (min-max 0–91) chats were sent from patients to practices; practices sent 6.93 ± 8.87 (min-max 0–49) messages; ▲Satisfaction with the PIA-Intervention (five-point scale: 1=very good to 5=poor) 1.76 ± 2.00 (patients), 1.8 ± 0.50 (general practices) | 12mo | ✓ | ✓ | ✓ | |
85 | 54.2 (14.3) | community | HT | Cardiovascular diseases: coronary heart disease, stroke, heart failure | NO | NR | NR | ▲Change in mean LS7 score 1.9 ± 1.9 (intervention), 0.7 ± 1.9 (control), RR = 1.13 (0.62, 1.65), intervention vs. control p < 0.0001; ▲Feasibility of intervention (Health-ITUES score) 4.2 ± 0.7 points (0.7) | ▲Healthy diet score (range 0–5) 0.79 ± 0.86 points (intervention), −0.08 ± 1.19 points (control), RR = 0.87 (0.54, 1.21), p < 0.0001; ▲ Physical activity 219.70 ± 396.73 min/week (intervention), 76.09 ± 286.67 (control), RR = 143.61 (7.67, 279.56), p = 0.04; ▲BMI 0.16 ± 1.30 kg/m2 (intervention), 0.14 ± 2.24 kg/m2 (control), RR = −0.30 (−1.23,0.62), p = 0.52; ▲SBP −3.09 ± 11.61 mmHg (intervention), −7.25 ± 13.14 mmHg (control), RR = 4.16 (−1.38, 9.70), p < 0.05; ▲DBP −0.53 ± 8.27 mmHg (intervention), −2.5 ± 11.85 mmHg (control), RR = 1.97 (−2.38, 6.31), p < 0.05; ▲Total cholesterol −10.96 ± 25.8 mg/dL(intervention), −17.74 ± 25.93 mg/dL(control), RR = 6.77 (−6.81, 20.36), p = 0.33; ▲Fasting glucose 2.89 ± 18.44 mg/dL (intervention), 6.73 ± 10.64 mg/dL (control), RR = −3.84 (−11.73, 4.05), p = 0.34 | 6mo | ✓ | ✓ | |||
Kyle Morawski (2018); USA [22] | 411 | 52.0 (-) | primary care /community | Uncontrolled HT + AM | No | Yes | 151.4 ± 9.0 mmHg (intervention) 151.3 ± 9.4 mmHg (control) | NR | ▲SBP − 10.6 ± 16.0 mmHg (intervention), −10.1 ± 15.4 mmHg (control), p = 0.97;▲MA (MMAS-8g) 0.4 ± 1.5 points (intervention), −0.01 ± 1.5 points (control), p < 0.01 | ▲Proportion of controlled BPa 67 (35.8%, intervention), 69 (37.9%, control), p = 0.34 | 3mo | ✓ | ✓ | ||
Ali Bozorgi (2021); Iran [32] | 120 | 52.0 51.6 | hospital | HT | No | No | 108.1 ± 13.5 mmHg (intervention) 114.9 ± 14.3 mmHg (control) | NR | ▲MA (Hill-Bone Checklist) 65.1 (65.04–65.23, intervention), 59.7 (59.60–20.36, control) at 24th week, mean change in intervention group 5.9 points (5.03, 6.69); | ▲Healthy diet adherence to low-fat diet (range 1–20) 1.7 (1.30–2.10) points, adherence to low-salt diet(range 1–20) 1.5 (1.16–1.90) points; ▲ BMI mean change 1.2 (0.77, 3.2) kg/m2; ▲MAPh mean change 3.4(1.6, 5.2) mmHg;▲Moderate physical activity (0–300 min/week) mean change 100.0 (61.7, 138.3) min/week; ▲The predisposing factors of adherence to treatment (knowledge, attitude, and self-efficacy) 2.9 points (1.6–4.2) in knowledge, 2.3 points (1.2–3.4) in attitude, 1.7 points (1.3–2.2) in self-efficacy;▲Satisfaction and usability of the app 18.41 (min 16, max 20) | 2mo | ✓ | ✓ | ✓ | ✓ |
Ke Gong (2020); China [29] | 443 | 59.27 (7.4) 58.20 (7.5) | hospital | HT | No | Yes | 141.19 ± 10.12 mmHg (intervention) 140.51 ± 10.44 mmHg (control) | 82.59 ± 9.621 mmHg (intervention) 83.89 ± 8.618 mmHg (control) | ▲SBP −8.99 ± 6.415 mmHg (intervention), −8.99 ± 6.415 mmHg (control), intervention vs. control p < 0.05; ▲DBP −7.04 ± 6.135 mmHg (intervention), −4.14 ± 8.213 mmHg (control), intervention vs. control p < 0.05; ▲Percentage of controlled BPi −38% (intervention), −28% (control), p = 0.00 | ▲Low medication adherence improvement§ 48 (21%, intervention), 18 (13%, control), p = 0.004 | 6mo | ✓ | ✓ | ✓ | |
Patricia J. Neafsey (2011); USA [27] | 160 | 68.6 (8.7) | primary care | HT + AM | Chronic Disease | No | 128.3 ± 14.6 mmHg (all) 129.1 ± 15.5 mmHg (intervention) 127.4 ± 13.4 mmHg (control) | 74.5 ± 9.5 mmHg (all) 74.27 ± 8.88 mmHg (control) 74.7 ± 10.1 mmHg (intervention) | ▲Patient Adverse Self-Medication Behavior Risk Score (Anderson and Spencer 2002) −4.5 (intervention), −2.4 (control), intervention vs. control p = 0.033 | ▲SBP −2.6 mmHg (intervention), 1.1 mmHg (control), change between groups was non-significant;▲DBP 2.0 mmHg (intervention), 0 mmHg (control), change between groups was non-significant; ▲OTC-Rx Knowledge Score −0.5(control), 4.2 (intervention), p < 0.05; ▲OTC-Rx self-efficacy 0.2 (control), 0.8 (intervention), p < 0.05; ▲Satisfaction with the PEP-NG between groups was 0.2, p = 0.0431 | 3mo | ✓ | |||
173 | 59.8 | tertiary hospitals | Uncontrolled HT + AM | NO | Yes | 148.9 ± 8.4 mmHg (intervention) 150.0 ± 8.6 mmHg (control) | NR | ▲Home SBP −20.0 ± 13.5 mmHg (SMBP-App) vs. −14.9 ± 12.9 mmHg (only SMBP), SMBP-App vs. only SMBP p = 0.012 | ▲MA95.2% (intervention),90.4%(control), p = 0.004; ▲Proportion of adherence over 95% 72/88 (intervention), 46/85 (control), p = 0.01 | 6mo | ✓ | ✓ | |||
Lesli E. Skolarus (2018); USA [26] | 73 | 58 (9.8) | community (churches) | Uncontrolled HT | NR | No | 160.7 ± 23.6 mmHg (intervention) 162.2 ± 20.5 mmHg (control) | 99.0 ± 11.8 mmHg (intervention) 99.2 ± 17.8 mmHg (control) | ▲Feasibility of the Reach Out processes 47% of participants texted back BP, 26% responded with their BP every week, 100% reported satisfaction with the intervention | ▲SBP −11.3 ± 22.9 mmHg (intervention), −14.4 ± 26.4 mmHg (control), p = 0.6; ▲DBP −8.6 ± 15.9 mm Hg (intervention), −9.5 ± 12.9 mmHg (control), p = 0.79 | 6mo | ✓ | ✓ | ✓ | |
Jessica Chandler (2020); USA [25] | 26 | 46.5 (13.0) 43.4 (14.2) | community and clinics | Stage 1 HTj | No | Yes | 133.2 mmHg (intervention) 132.0 mmHg (control) | 75.1 mmHg (intervention) 77.4 mmHg (control) | ΔSBP −11.6 mmHg (intervention), −0.2 mmHg (control), p < 0.04 | ▲DBP −6.4 mmHg (intervention), 2.4 mmHg (control), p < 0.04; ▲Percentage of participants with SBP < 130 mmHg 60.3% (Tension Tamer), 35.8% (control), p = 0.003; ▲ Proportion of participants meeting 75% adherence benchmark 38.5% (Tension Tamer), 27.3% (control), p = 0.582 | 12mo | ✓ | |||
