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Children with congenital heart disease (CHD) are at risk for executive functions (EF) impairments. To date, interventions have limited effects on EF in children and adolescents with complex CHD. Therefore, we developed a new multimodal and personalised EF intervention (E-Fit). This study aims to test the feasibility of this intervention called ‘E-Fit’ for children with complex CHD and EF impairments.
This is a single-centre, single-blinded, randomised controlled feasibility study exploring the E-Fit intervention. We aim to enrol 40 children with CHD aged 10–12 years who underwent infant cardiopulmonary bypass surgery and show clinically relevant EF impairments (T-score ≥60 on any Behaviour Rating Inventory for Executive Function questionnaire summary scale). The multimodal intervention was developed with focus groups and the Delphi method involving children and adolescents with CHD, their parents and teachers, and health professionals. The intervention is composed of three elements: computer-based EF training using CogniFit Inc 2022, performed three times a week at home; weekly EF remote strategy coaching and analogue games. The content of the computer and strategy training is personalised to the child’s EF difficulties. The control group follows their daily routines as before and completes a diary about their everyday activities four times a week. Participants will be randomised in a 1:1 ratio. Feasibility is measured by the participants’ and providers’ ratings of the participants’ adherence and exposure to the intervention, recruitment rates and the evaluation of the intended effects of the programme.
Local ethics committee approval was obtained for the study (BASEC-Nr: 2021-02413). Parents provide written informed consent. Key outputs from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly to participating families. Furthermore, these results will inform the decision whether to proceed to a randomised controlled trial to investigate effectiveness.
Objetivo principal: Evaluar la disfunción familiar desde una perspectiva holística en enfermos renales en terapia sustitutiva en un hospital de Monterrey, México. Metodología: Diseño mixto, analítico, transversal. Población conformada por 634 enfermos renales en terapias de sustitución de un hospital de segundo nivel en Monterrey. Se usó estadística descriptiva e inferencial para datos cuantitativos. Para la parte cualitativa se usó metodología fenomenológica conforme a la teoría fundamentada y análisis de dominios. Resultados principales: Alta prevalencia de disfuncionalidad familiar (70%). Según los enfermos renales en etapas avanzadas, el abandono por parte del cónyuge, la infidelidad marital, la exclusión familiar y los problemas económicos, son los principales factores que fracturan los lazos y la estruc-tura familiar. Conclusión principal: La enfermedad renal puede ser factor de disfuncionalidad familiar, hecho que compromete las relacio-nes entre los miembros familiares y afecta el apego a los tratamientos sustitutivos, al ser estos dependientes de un cuidador primario.
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