Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Oct 24, 2023
Date Accepted: Jun 3, 2024
Effect of a Mobile Health-Based Remote Interaction Management Intervention on the Quality of Life and Self-Management Behavior of Patients with Low Anterior Resection Syndrome: Randomized Controlled Trial
ABSTRACT
Background:
People who undergo sphincter-preserving surgery have high rates of anorectal functional disturbances, known as low anterior resection syndrome (LARS). LARS negatively affects patients’ quality of life (QoL) and increases their need for self-management behaviors. A high level of self-management behavior effectively improved the impact of LARS on patients. Therefore, approaches to enhance self-management behavior and QoL are vital.
Objective:
This study aimed to assess the effectiveness of a remote interactive management intervention designed to enhance the QoL and self-management behavior of patients with LARS.
Methods:
From July 2022 to May 2023, we conducted a single-blinded randomized controlled trial (RCT) and recruited 120 patients with LARS in a tertiary hospital in Hefei, China. All participants were randomly assigned to the intervention group (using the ‘e-bowel safety’ applet and monthly Motivational interviewing) or the control group (usual care and an information booklet). Our team provided a 3-month intervention and followed up with all participants for an additional 3 months. The primary outcome was patient QoL measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC-QLQ-C30). The secondary outcomes were evaluated using the Bowel Symptoms Self-management Behaviors Questionnaire (BSSBQ), LARS Score, and Perceived Social Support Scale (PSSS). Data collection occurred at study enrollment, the end of the three-month intervention, and the three-month follow-up.
Results:
In the end, 111 participants completed the study. In the intervention group, 5 participants withdrew; 4 participants withdrew in the control group. Compared with the participants in the control group, those in the intervention group had significantly larger improvements in the EORTC-QLQ-C30 total score (mean difference 11.51, 95% CI 10.68–12.35, Cohen’s d=1.73) and BSSBQ total score (mean difference 8.80, 95% CI 8.28–9.32, Cohen’s d=1.94) after intervention, and this improvement effect remained stable at 3-month follow-up (mean difference 14.47, 95% CI 13.65–15.30, Cohen’s d=1.58), (mean difference 8.85, 95% CI 8.25–9.42, Cohen’s d=2.23). The LARS Score total score had significantly larger decreases after intervention (mean difference -3.28, 95% CI -4.03 to -2.54, Cohen’s d=-0.39) and at 3-month follow-up (mean difference -6.69, 95% CI -7.45 to -5.93, Cohen’s d=-0.69). The PSSS total score had significantly larger improvements after intervention (mean difference 0.47, 95% CI 0.22–0.71, Cohen’s d=1.81); however, this effect did not persist at 3-month follow-up (mean difference 0.23, 95% CI -0.20 to 0.45; P=0.074).
Conclusions:
Our preliminary findings suggest that the mobile health-based remote interaction management intervention significantly enhanced the self-management behaviors and QoL of patients with LARS, and the effect was sustained. Mobile health-based remote interventions become an effective method to improve health outcomes for many patients with LARS. Clinical Trial: Chinese Clinical Trial Registry (ChiCTR2200061317).
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