» Articles » PMID: 34281108

Monitoring Patients Reported Outcomes After Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results

Abstract

Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.

Citing Articles

Digital Health Technologies in Pediatric Infectious Disease and the Perspective of Patients and Healthcare Professionals: A Review.

Saji A, Komel A, Khan M, Niraula S, Naeem B, Ahsan A Health Sci Rep. 2025; 8(3):e70514.

PMID: 40041773 PMC: 11872690. DOI: 10.1002/hsr2.70514.


Implementing sensor-based digital health technologies in clinical trials: Key considerations from the eCOA Consortium.

Izmailova E, Middleton D, Yunis R, Lakeland J, Sowalsky K, Kling J Clin Transl Sci. 2024; 17(11):e70054.

PMID: 39491883 PMC: 11532371. DOI: 10.1111/cts.70054.


Percutaneous Valvular and Structural Heart Disease Interventions. 2024 Core Curriculum of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC in collaboration with the European Association of Cardiovascular....

Teles R, Van Belle E, Parma R, Tarantini G, van Mieghem N, Mylotte D EuroIntervention. 2024; .

PMID: 39207816 PMC: 11556405. DOI: 10.4244/EIJ-D-23-00983.


Ambulatory Smartwatch ECG Monitoring among Patients Undergoing Transcatheter Aortic Valve Replacement Early after Discharge: An Observational Study.

Zhang Y, Xiong T, Yang X, Chen D, Li Y, Bao Y Rev Cardiovasc Med. 2024; 24(1):11.

PMID: 39076857 PMC: 11270444. DOI: 10.31083/j.rcm2401011.


Effective health management strategies for patients undergoing valve replacement: a bibliometric analysis of the current research status and future directions.

Wang X, Wu Y, Li M, Wen J, Liu L, Huang W Front Cardiovasc Med. 2024; 11:1352437.

PMID: 38476380 PMC: 10929617. DOI: 10.3389/fcvm.2024.1352437.


References
1.
Chandrasekaran R, Katthula V, Moustakas E . Patterns of Use and Key Predictors for the Use of Wearable Health Care Devices by US Adults: Insights from a National Survey. J Med Internet Res. 2020; 22(10):e22443. PMC: 7600024. DOI: 10.2196/22443. View

2.
MAHONEY F, BARTHEL D . FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965; 14:61-5. View

3.
Kononova A, Li L, Kamp K, Bowen M, Rikard R, Cotten S . The Use of Wearable Activity Trackers Among Older Adults: Focus Group Study of Tracker Perceptions, Motivators, and Barriers in the Maintenance Stage of Behavior Change. JMIR Mhealth Uhealth. 2019; 7(4):e9832. PMC: 6473213. DOI: 10.2196/mhealth.9832. View

4.
Hlatky M, Boineau R, Higginbotham M, Lee K, Mark D, Califf R . A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989; 64(10):651-4. DOI: 10.1016/0002-9149(89)90496-7. View

5.
Byrom B, Watson C, Doll H, Coons S, Eremenco S, Ballinger R . Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. Value Health. 2018; 21(6):631-639. DOI: 10.1016/j.jval.2017.09.012. View