Smartphone-based mobile health impact on oral anticoagulation adherence, quality of life, and healthcare utilization in adult atrial fibrillation

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

RCT: Randomized controlled trial: ABC: Atrial fibrillation better care; OAC: Oral anticoagulant; TE: Thromboembolism; AS-BLED: Reassessment score–hypertension, abnormal renal/Liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol; mHealth: Mobile health; ADHERE-app trial: Application-driven heart rhythm education and empowerment trial; SmartADHERE trial: Smartphone-based adherence to anticoagulation and heart rhythm education trial; PDC: Proportion of days covered; ECG: Electrocardiogram; iHEART: Interactive heart health application for rhythm tracking; AFEQT: Atrial fibrillation effect on quality-of-life questionnaire; MMAS-8: 8-item morisky medication adherence scale: AF: Atrial fibrillation; BOAT-OAR: Bleeding outcomes and thromboembolism in oral anticoagulant-related trial.