A simulation training of family management for parents of children with epilepsy: a randomized clinical trial.

2024-04-19
Italian journal of pediatrics 50(1)
- Hua-Yan Liu
- Shan Zeng
- Yue-Wei Chen
- Min Yi
- Xiao-Yan Tan
- Jian-Hui Xie
- Xia Wu
- Li-Hui Zhu

PubMed: 38641843
DOI: 10.1186/s13052-024-01646-5

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 463
Population: 463 children with epilepsy and their families
Methods: A randomized controlled trial; 1:1 ratio to STOFMS group or conventional group; scores collected at admission, 3 months after discharge, and 6 months after discharge; repeated-measures ANOVA
Duration: 6 months after discharge

Large Human Trial

Background

Epilepsy is a chronic neurological disorder that is more likely to be diagnosed in children. The main treatment involves long-term use of anti-epileptic drugs and above all, home care is of great importance. As there has not been a widely accepted home care protocols, simulating a home care environment is necessary for caregivers to develop skills of proper home care. This study aims to evaluate the effectiveness of a simulation training of family management style (STOFMS) for parents of children with epilepsy in China.

Methods

A randomized controlled trial was conducted on 463 children with epilepsy and their families. They were recruited from March 2020 to November 2022 and randomly assigned to the STOFMS group or the conventional group in a 1:1 ratio. Scores of family management measures, 8-item of Morisky Medication Adherence and epilepsy clinical symptom of both groups were collected at three points of time: within 24 h after admission (T0), 3 months after discharge (T1), and 6 months after discharge (T2). Changes due to intervention were compared across groups by repeated-measures ANOVA. The study report followed the CONSORT 2010 checklist.

Results

There were statistically significant differences between the two groups at T2. A considerable increase over the baseline was observed in the total management level score and subscale scores in the STOFMS group at T1, compared with essentially no change in the control group. In terms of medication adherence, the STOFMS group performance improved greatly at T1 and T2 compared with the control group. The same result was also found in clinical efficacy at T2 (p < 0.05).

Conclusion

STOFMS is an effective intervention to improve family management level, treatment adherence and clinical efficacy for children with epilepsy.

Trial registration

The registration number is ChiCTR2200065128. Registered at 18 October 2022, http://www.medresman.org.cn.