Effects of the transtheoretical model-based self-management program on behavioral change in persons with epilepsy: Study protocol for a randomized controlled trial

Abstract

Introduction: Self-management applications are cost-effective and scalable for epilepsy treatment. However, there is a limited long-term quantitative evidence regarding their effectiveness. The Transtheoretical Model (TTM) offers a psychological framework that tailors self-management plans to the individual's stage of behavioral change. This approach aims to address utilization needs, reduce information overload, minimize the adverse effects of self-management, and enhance the overall effectiveness of interventions for individuals with epilepsy.

Methods and analysis: This will be a randomized, double-blind, the clinical trial involving two groups of adults diagnosed with epilepsy. In addition to treatment as usual (TAU), the intervention group will receive an intervention program constructed from TTM combined with self-management as part of the treatment plan. The control group will receive TAU only. Prior to the intervention, the participants will undergo an initial assessment to determine their current stage of behavioral change to facilitate the implementation of targeted behavior support strategies. Additionally, participants will receive weekly 30-minute educational videos on epilepsy. The goal is to enroll 160 adults who have been diagnosed with epilepsy for at least six months and are receiving medication. Data collection will encompass an assessment of C-ESMS, HADS, QOLIE-31, and LSSS. These parameters will be evaluated at baseline, as well as during follow-up periods at 1, 3, and 6 months post-intervention.

Discussion: Existing self-management interventions for people with epilepsy primarily focus on knowledge and psychological factors. Discrepancies in research design, intervention plans, and patient characteristics have contributed to inconsistent outcomes in previous studies. This study seeks to advance the field by integrating the TTM with empirically supported self-management practices. The delineation of behavioral change stages within the TTM framework is expected to form a structured intervention protocol. This study will inform standardized, evidence-based epilepsy care practices.

Fig 1. Schedule of enrolment, interventions, and assessments for epilepsy management study.

Fig 2. Recruitment process flowchart.

(A)Ovals: Process start/end. (B)Rectangles:Steps. (C)Diamonds:Decisions. (D)Arrows:Flow.direction. (E)Lines:Connections between steps.