Usability and Preliminary Effectiveness of a Preoperative mHealth App for People Undergoing Major Surgery: Pilot Randomized Controlled Trial.

BACKGROUND: Major surgery is associated with negative postoperative outcomes such as complications and delayed or poor recovery. Multimodal prehabilitation can help to reduce the negative effects of major surgery. Offering prehabilitation by means of mobile health (mHealth) could be an effective new approach.
OBJECTIVE: The objectives of this pilot study were to (1) evaluate the usability of the Be Prepared mHealth app prototype for people undergoing major surgery, (2) explore whether the app was capable of bringing about a change in risk behaviors, and (3) estimate a preliminary effect of the app on functional recovery after major surgery.
METHODS: A mixed-methods pilot randomized controlled trial was conducted in two Dutch academic hospitals. In total, 86 people undergoing major surgery participated. Participants in the intervention group received access to the Be Prepared app, a smartphone app using behavior change techniques to address risk behavior prior to surgery. Both groups received care as usual. Usability (System Usability Scale), change in risk behaviors 3 days prior to surgery, and functional recovery 30 days after discharge from hospital (Patient-Reported Outcomes Measurement Information System physical functioning 8-item short form) were assessed using online questionnaires. Quantitative data were analyzed using descriptive statistics, chi-square tests, and multivariable linear regression. Semistructured interviews about the usability of the app were conducted with 12 participants in the intervention group. Thematic analysis was used to analyze qualitative data.
RESULTS: Seventy-nine people-40 in the intervention group and 39 in the control group-were available for further analysis. Participants had a median age of 61 (interquartile range 51.0-68.0) years. The System Usability Scale showed that patients considered the Be Prepared app to have acceptable usability (mean 68.2 [SD 18.4]). Interviews supported the usability of the app. The major point of improvement identified was further personalization of the app. Compared with the control group, the intervention group showed an increase in self-reported physical activity and muscle strengthening activities prior to surgery. Also, 2 of 2 frequent alcohol users in the intervention group versus 1 of 9 in the control group drank less alcohol in the run-up to surgery. No difference was found in change of smoking cessation. Between-group analysis showed no meaningful differences in functional recovery after correction for baseline values (β=-2.4 [95% CI -5.9 to 1.1]).
CONCLUSIONS: The Be Prepared app prototype shows potential in terms of usability and changing risk behavior prior to major surgery. No preliminary effect of the app on functional recovery was found. Points of improvement have been identified with which the app and future research can be optimized. TRIAL REGISTRATION: Netherlands Trial Registry NL8623; https://www.trialregister.nl/trial/8623. ©Miriam van der Velde, Karin Valkenet, Edwin Geleijn, Marjoke Kruisselbrink, Marije Marsman, Liedewij MJ Janssen, Jelle P Ruurda, Donald L van der Peet, Jesse J Aarden, Cindy Veenhof, Marike van der Leeden. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 07.01.2021.

RCT Entities:   Population Interventions Outcomes