Copyright: ©Author(s) 2026.
World J Methodol. Sep 20, 2026; 16(3): 117065
Published online Sep 20, 2026. doi: 10.5662/wjm.117065
Published online Sep 20, 2026. doi: 10.5662/wjm.117065
Table 1 Characteristics of included studies (n = 16)
| Ref. | Country/setting | Study design and focus | Trial/program name | Sample size (intervention/control) | Key participant characteristics | Intervention description | Follow-up duration | Primary outcomes assessed |
| mAFA-II program cluster (integrated care via ABC pathway) | ||||||||
| Guo et al[23], 2020 | China; 40 centers | Cluster RCT; efficacy of integrated care | mAFA-II | 3324 (1646/1678) | Mean age 67-70 years; 38% female | mHealth-supported ABC pathway (risk scores, OAC guidance, education) | Mean 262-291 days | Composite (stroke/TE, death, rehospitalization) |
| Romiti et al[24], 2023 | China; 40 centers | Post-hoc analysis; win ratio method | mAFA-II | 3324 | (Subset of core trial population) | ABC pathway (as in core trial) | Mean 291 days | Composite outcome analyzed via win ratio |
| Yao et al[25], 2021 | China; 40 centers | Ancillary analysis; patients with multimorbidity | mAFA-II | 1890 (subgroup with ≥ 2 comorbidities) | Mean age 72-73 years; 34%-42% Female | ABC pathway | Mean 419-457 days | Composite outcome, thromboembolism, bleeding |
| Guo et al[26], 2022 | China; 40 centers | Subgroup analysis; patients ≥ 75 years | mAFA-II | 1163 (subgroup ≥ 75 years) | Mean age 827 ± 5.2 years | ABC pathway | Median about 340-395 days | Composite outcome, rehospitalization |
| Guo et al[27], 2023 | China; 40 centers | Post-hoc analysis; patients with heart failure | mAFA-II | 714 (subgroup with HF) | Mean age 727 ± 13.1 years; 40% Female | ABC pathway | Median about 281-284 days | Composite outcome, bleeding, non-fatal CV events |
| Corica et al[28], 2025 | China; 40 centers | Post-hoc analysis; latent class analysis (phenotypes) | mAFA-II | 3324 | Mean age 685 ± 13.9 years | ABC pathway | Median 295 days | Interaction between phenotypes and treatment effect |
| Guo et al[29], 2023 | China; 40 centers | Post-hoc analysis; Sex-stratified outcomes | mAFA-II | 3324 (2062 male/1262 fem ale) | Mean age male: 67.5, female: 70.2 years | ABC pathway | 6 and 12 months | Composite outcome stratified by sex |
| Guo et al[30], 2020 | China; 2 hospitals | Ancillary study; dynamic bleeding risk | mAFA (pilot/II) | 1,793 (intervention arm only) | Mean age 640 ± 24.0 years | Dynamic HAS-BLED reassessment via app | Dynamic monitoring (up to 365 days) | Change in high bleeding risk, incident bleeding |
| Guo et al[31], 2017 | China; 2 hospitals | Pilot cluster RCT; feasibility | mAFA pilot | 209 (113/96) | Mean age 67-71 years | mAF app (management, self-care) | 3 months | Adherence, quality of life, satisfaction |
| Independent trials | ||||||||
| Yoon et al[32], 2024 | South Korea; Multicenter | RCT; adherence via alerts | ADHERE-app | 498 | Mean age 657 years; 68% male (Edoxaban users) | App with daily push alerts + BP/HR monitoring | 6 months | Adherence (pill count) |
| Turakhia et al[33], 2021 | United States; 25 sites | RCT (terminated early); digital/human support | SmartADHERE | 139 enrolled | Mean age 65 ± 9.6 years; 30% female (Rivaroxaban users) | App + text messaging + phone counseling | 6 months (planned) | PDC |
| Caceres et al[34], 2020 | United States; single-center | RCT; ECG monitoring post-procedure | iHEART | 238 (post-ablation/cardioversion) | Mean age 613 years; 77% male | Smartphone ECG (Kardia) + motivational texts | 6 months | Quality of life (AFEQT, etc.), symptom severity |
| Hsieh et al[35], 2021 | Taiwan; single-center | Single-blind RCT; web-based management | Web-based program | 231 | Mean age 731 ± 11.7 years; 50% male | Web-based program (education, consultation) | 6 months (outcomes) + 2 years (readmission) | Adherence, quality of life, readmission events |
| Xu et al[36], 2024 | China; 5 hospitals | RCT; app-based education and support | Alfalfa app | 113 | Mean age 617 ± 11.0 years; 62% male | Alfalfa app (education, remote consultation) | 12 months | Adherence (MMAS-8), knowledge, satisfaction |
| Magnani et al[37], 2025 | United States; rural pennsylvania | RCT; intervention for rural patients | Rural AF intervention | 270 (rural cohort) | Median age 731 years; 60% female | Relational agent app + KardiaMobile monitor | 12 months | Adherence (PDC), quality of life, healthcare utilization |
| Tran et al[38], 2022 | United States; single-center | RCT; Pill organizer + monitoring | BOAT-OAR | 100 (Apixaban users) | Mean age 708 ± 8.0 years; 50% female | Smartphone ECG + pill organizer | Median 5.9 months | Medication compliance (pill count), clinical events |
Table 2 Oral anticoagulant adherence
| Ref. | Intervention/trial name | Adherence metric | Follow-up | Key finding | Interpretation |
| Studies reporting a positive effect on adherence | |||||
| Yoon et al[32], 2024 | ADHERE-app (Alerts + monitoring) | Pill count (≥ 95% threshold) | 6 months | Proportion with adequate adherence (≥ 95%) significantly higher in intervention (73.9% vs 61.0%; P = 0.007) | Intervention increased the likelihood of achieving high adherence |
| Hsieh et al[35], 2021 | Web-based integrated program | MARS (self-report scale) | 6 months | Significantly greater improvement in adherence vs control over time (GEE analysis, P = 0.001) | Sustained improvement in self-reported adherence |
| Xu et al[36], 2024 | Alfalfa app (education + consultation) | MMAS-8 (self-report scale) | 3 months | Medication compliance significantly higher at 1 and 3 months (all P < 0.05) | Short-term improvement in self-reported adherence |
| Guo et al[31], 2017 | mAFA pilot (mAF app) | 3-item adherence estimator | 3 months | Drug adherence significantly better at 1 and 3 months (all P < 0.05) | Early improvement in adherence with integrated app |
| Magnani et al[37], 2025 | Rural AF intervention (agent + monitor) | 3-item self-report instrument | 4 and 8 months | Self-reported adherence significantly higher (OR = 1.89) | Positive subjective effect, despite no objective difference |
| Guo et al[30], 2020 | mAFA-II (dynamic management) | OAC usage/uptake | 12 months | OAC use increased in intervention (63.4% to 70.2%) but decreased in control (P < 0.001) | Intervention improved OAC persistence at a population level |
| Studies reporting no significant difference in objective adherence | |||||
| Yoon et al[32], 2024 | ADHERE-app (alerts + monitoring) | Pill count (continuous median) | 6 months | No difference in median adherence (98% vs 97.5%; P = 0.15). | High baseline adherence in both groups limited improvement |
| Turakhia et al[33], 2021 | SmartADHERE (blended support) | PDC | 6 months | No difference in mean PDC (0.86 vs 0.88; P = 0.62) or PDC ≥ 80% | Exceptionally high adherence in control group (“ceiling effect”) |
| Tran et al[38], 2022 | BOAT-OAR (ECG + organizer) | Pill Count (median) | 5.9 months | No difference in median compliance (100% vs 99.7%; P = 0.247) | Near-perfect adherence in both groups |
| Magnani et al[37], 2025 | Rural AF intervention (agent + monitor) | PDC | 12 months | No difference in 12-month PDC (median 0.97 both groups) | Objective measure did not confirm self-reported benefits |
Table 3 Impact of mobile health interventions on patient-reported outcomes
| Ref. | Intervention/trial name | PRO domain and measurement tool | Follow-up | Key finding |
| Studies reporting significant improvements | ||||
| Hsieh et al[35], 2021 | Web-based integrated program | HRQoL: EQ-5D-3 L and EQ-VAS | 6 months | Significantly higher scores in intervention group at 3 and 6 months (e.g., EQ-5D, β = 0.19, P < 0.001 at 6 months) |
| Hsieh et al[35], 2021 | Web-based integrated program | Coping: Brief COPE scale | 6 months | Significantly improved approach coping and reduced avoidance coping (P < 0.001) |
| Guo et al[31], 2017 | mAFA pilot trial | HRQoL: EQ-5D-Y; satisfaction: ACTS | 3 months | Significantly increased QoL, reduced anxiety/depression, and higher satisfaction (all P < 0.05) |
| Xu et al[36], 2024 | Alfalfa app study | Satisfaction: Treatment satisfaction questionnaire for medication | 3 months | Scores for effectiveness, side effects, convenience, and global satisfaction significantly higher (P < 0.001) |
| Studies reporting no significant difference | ||||
| Caceres et al[34], 2021 | iHEART study (ECG + texts) | HRQoL: AFEQT, SF-36, EQ-5D | 6 months | No significant differences between groups. Clinically meaningful improvement observed in both arms |
| Magnani et al[37], 2025 | Rural AF intervention | HRQoL: AFEQT, PROMIS-29 | 12 months | No significant differences in disease-specific or general quality of life scores |
Table 4 Impact of mobile health interventions on clinical events and healthcare utilization
| Ref. | Intervention/trial name | Outcome metric | Result (intervention vs control) | Effect estimate (95%CI) | P value |
| Clinical efficacy and healthcare utilization | |||||
| Guo et al[23], 2020 | mAFA-II trial | Primary composite (stroke/TE, death, rehospitalization) | 1.9% vs 6.0% | HR 0.39 (0.22-0.67) | < 0.001 |
| Guo et al[23], 2020 | mAFA-II trial | Rehospitalization (any cause) | 1.2% vs 4.5% | HR 0.32 (0.17-0.60) | < 0.001 |
| Romiti et al[24], 2023 | mAFA-II (win ratio) | Composite (prioritizing death) | Win ratio 2.78 (1.85-4.17) | < 0.001 | |
| Yao et al[25], 2021 | mAFA-II (multimorbidity) | Primary composite outcome | HR 0.37 (0.26-0.53) | < 0.001 | |
| Hsieh et al[35], 2021 | Web-based program | Readmission (2-year follow-up) | 11 vs 23 events | OR 0.41 (0.18-0.93) | 0.03 |
| Safety (bleeding and thromboembolism) | |||||
| Yao et al[25], 2021 | mAFA-II (multimorbidity) | Thromboembolism (stroke/TE) | 0.5% vs 2.9% | HR 0.17 (0.05-0.51) | 0.002 |
| Guo et al[23], 2020 | mAFA-II trial | Extracranial bleeding | 1.5% vs 1.6% | HR 0.95 (0.54-1.66) | 0.85 |
| Guo et al[30], 2020 | mAFA-II (dynamic) | Incident bleeding events (rate) | Rate decreased over time (1.2% to 0.2%) | < 0.001 | |
Table 5 Mechanisms of action and feasibility of mobile health intervention
| Ref. | Intervention/trial name | Process outcome domain | Key finding |
| Feasibility and engagement | |||
| Magnani et al[37], 2025 | Rural AF intervention | Intervention fidelity: Median use of relational agent over 120 days | Excellent fidelity; participants used the agent a median of 84% of days |
| Guo et al., 2020[23] | mAFA-II (dynamic risk) | Communication fidelity: Frequency of patient/doctor messages | Significant, sustained message frequency over 12 months (P < 0.001) |
| Hsieh et al[35], 2021 | Web-based program | Intervention delivery | Implemented via face-to-face training to ensure user competency |
| Patient activation and knowledge | |||
| Xu et al[36], 2024 | Alfalfa app study | Anticoagulation knowledge (JAKQ) | Knowledge significantly higher in app group at 1 and 3 months (e.g., 78.1% vs 25.0% at 3 months; P < 0.001) |
| Hsieh et al[35], 2021 | Web-based program | Coping strategies (brief COPE scale) | Significantly improved approach coping and reduced avoidance coping (P < 0.001) |
| Treatment optimization | |||
| Guo et al[23], 2020 | mAFA-II (dynamic risk) | OAC treatment uptake/persistence | OAC use increased in intervention arm (63.4% to 70.2%) but decreased by 25% in usual care (P < 0.001) |
Table 6 Risk of bias assessment
| Ref. | D1 | D2 | D3 | D4 | D5 | Overall |
| Guo et al[23], 2020 | Some concerns | High | Low | High | Low | High |
| Romiti et al[24], 2023 | Some concerns | High | Low | High | Low | High |
| Yao et al[25], 2021 | Some concerns | High | Low | High | Some concerns | High |
| Guo et al[26], 2022 | Some concerns | High | Low | High | Some concerns | High |
| Guo et al[27], 2023 | Some concerns | High | Low | High | Some concerns | High |
| Corica et al[28], 2025 | Some concerns | High | Low | High | High | High |
| Guo et al[29], 2023 | Some concerns | High | Low | High | High | High |
| Guo et al[30], 2020 | No information | No information | Low | Low | Low | Some concerns |
| Guo et al[31], 2017 | Some concerns | High | Low | High | Low | High |
| Yoon et al[32], 2024 | Low | Some concerns | Some concerns | Low | Low | Some concerns |
| Turakhia et al[33], 2021 | Low | Some concerns | High | Some concerns | Low | High |
| Caceres et al[34], 2020 | Low | Some concerns | High | Some concerns | Some concerns | High |
| Hsieh et al[35], 2021 | Low | Some concerns | Low | Some concerns | Low | Some concerns |
| Xu et al[36], 2024 | Low | Some concerns | Low | Some concerns | Low | Some concerns |
| Magnani et al[37], 2025 | Low | Some concerns | Low | Some concerns | Low | Some concerns |
| Tran et al[38], 2022 | Low | Some concerns | Low | Some concerns | Low | Some concerns |
- Citation: Farhan M, Patel T, Harazeen W, Mohamed Y, Al Azzawi A, Intabli H, Ahmed N, Obais MAHN, Alkhazali MR, Patel BD, Ahmad A, Awosika A. Smartphone-based mobile health impact on oral anticoagulation adherence, quality of life, and healthcare utilization in adult atrial fibrillation. World J Methodol 2026; 16(3): 117065
- URL: https://www.wjgnet.com/2222-0682/full/v16/i3/117065.htm
- DOI: https://dx.doi.org/10.5662/wjm.117065