Dataset Information

The Effects of Implementing a Mobile Health-Technology Supported Pathway on Atrial Fibrillation-Related Adverse Events Among Patients With Multimorbidity: The mAFA-II Randomized Clinical Trial.

ABSTRACT:

Importance

The Mobile Health Technology for Improved Screening and Optimized Integrated Care in Atrial Fibrillation (mAFA-II) trial is a prospective cluster randomized trial that found a significant reduction in the composite clinical outcome of stroke or thromboembolism, all-cause death, and rehospitalization among patients with atrial fibrillation (AF) who used a mobile health (mHealth) technology that implemented the Atrial Fibrillation Better Care (ABC) pathway (ie, A, anticoagulation/avoid stroke; B, better symptom control; and C, cardiovascular disease and comorbidity management) compared with those receiving usual care. Multimorbidity (defined as ≥2 chronic long-term conditions) is common in older patients with AF, but the impact of integrated or holistic care (based on the ABC pathway) on clinical outcomes in this population is uncertain.

Objective

To evaluate whether implementation of the integrated ABC pathway, supported by mHealth technology, would reduce AF-related adverse events in patients with multimorbidity.

Design, setting, and participants

This prespecified ancillary analysis of data from the extended follow-up of the mAFA II trial was conducted between June 2018 and April 2021. Adult patients with AF were included in the analysis if they had at least 2 comorbidities. Participants were enrolled across 40 centers in China.

Intervention

Integrated care supported by mHealth technology (mAFA intervention) vs usual care.

Main outcomes and measures

The main outcome was the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization. Cox proportional hazard modeling was performed for adverse outcomes after adjusting for cluster effect and baseline risk factors.

Results

Of 1890 patients, 833 (mean [SD] age, 72.0 [12.0] years; 278 [33.4%] women) with multimorbidity were allocated to the intervention group (ABC pathway), with a mean (SD) follow-up of 419 (257) days, and 1057 patients (mean [SD] age, 72.8 [13.0] years; 443 [41.9%] women) with multimorbidity were allocated to usual care, with a mean (SD) follow-up of 457 (154) days. Compared with usual care, the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization was significantly reduced in the intervention group (hazard ratio [HR], 0.37; 95% CI, 0.26-0.53; P < .001), as were rehospitalizations alone (HR, 0.42; 95% CI, 0.27-0.64; P < .001). For the C criterion of the ABC pathway, rates of acute coronary syndrome, heart failure, and uncontrolled blood pressure during follow-up were lower in the intervention group than the usual care group (27 patients [3.2%] vs 145 patients [13.7%]; HR, 0.29; 95% CI, 0.19-0.45; P < .001). Subgroup analyses by age, prior stroke, and sex demonstrated consistently lower HRs for the primary composite outcome and rehospitalization for patients with AF allocated to the intervention group compared with patients receiving usual care.

Conclusions and relevance

In this study, mHealth technology-based integrated care that facilitated the implementation of the ABC pathway reduced meaningful clinical adverse events in older patients with AF and multimorbidity vs usual care.

Trial registration

WHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR-OOC-17014138.

SUBMITTER: Yao Y

PROVIDER: S-EPMC8693229 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAtrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence.ObjectiveThis study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence.MethodsParticipants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants' use and acceptability of the intervention.ResultsA total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy.ConclusionsIndividuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.

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