Effect of a continuous care model-based program on fatigue, self-efficacy, and quality of life in patients with Parkinson's disease: study protocol for a randomized controlled trial.

Background: Neurological disorders, including Parkinson's disease (PD), are among the leading causes of disability worldwide. One of the major challenges of this disease is chronic fatigue, which is considered one of the most common and debilitating non-motor symptoms. Increased fatigue in these patients reduces their self-efficacy, which directly correlates with decreased quality of life (QOL) and worsening motor and non-motor symptoms. Given the profound impact of PD on patients' daily lives, adopting effective approaches to improve their QOL is essential. The continuous care model (CCM), designed as an indigenous approach based on Iran's cultural and social characteristics, can serve as an effective strategy for managing complications associated with PD.

Methods: This study is a clinical trial aimed at evaluating the effect of the CCM on fatigue, self-efficacy, and QOL in patients with PD in Isfahan, Iran. A total of 80 patients will be selected through convenience sampling and randomly assigned to either the intervention or control group. Data will be collected using standardized questionnaires at three time points: before the intervention, immediately after, and 1 month later. In the intervention group, the CCM will be implemented over a nine-week period in four stages: familiarization, sensitization, control, and evaluation. The control group will receive only routine pharmacological care. Data will be analyzed using descriptive statistics (mean and standard deviation), followed by repeated measures ANCOVA to compare changes in outcomes across three time points between groups, controlling for covariates. Normality and homogeneity of variances will be assessed using the Kolmogorov-Smirnov and Levene's tests, respectively.

Discussion: Various approaches have been proposed to manage fatigue, enhance self-efficacy, and improve QOL in patients with PD; however, many of these strategies face challenges, including the lack of a comprehensive approach. The CCM focuses on the care of patients with chronic conditions, emphasizing education and empowerment for both patients and their families. By placing the patient at the center of care, this holistic approach plays a crucial role in the management of chronic diseases.

Trial registration: It is registered in the Iranian Registry of Clinical Trials (IRCT) with the registration number IRCT20190712044181N7.