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Effectiveness of the Preschool Children eHealth Cardiac Rehabilitation Program After Congenital Heart Surgery: A Randomised Controlled Trial

ABSTRACT

Aim(s)

To develop the Preschool Children eHealth Cardiac Rehabilitation programme based on the Interaction Model of Client Health Behaviour, and to evaluate its effects on children after congenital heart surgery.

Design

A parallel two-arm randomised controlled trial was conducted.

Methods

A total of 84 participants were recruited from July 2022 to June 2023 and randomly assigned to either the intervention group (n = 40) or control group (n = 44). The intervention group participated in a 3-month eHealth Cardiac Rehabilitation programme, while the control group received routine care. Outcomes were measured at baseline, 3 months post baseline (intervention endpoint), and 6 months post baseline. Eighty participants completed the study.

Results

Compared to the intervention group, the control group demonstrated significantly worse outcomes at both 3 and 6 months, including a higher risk of heart failure, lower left ventricular ejection fraction scores, and shorter 6-min walk distance tests. The intervention group engaged in significantly more vigorous physical activity. Significant between group differences were also observed in parental knowledge, attitudes, behaviours and trust levels. Additionally, the proportion of parents experiencing anxiety decreased significantly more in the intervention group by 6 months post baseline.

Conclusion

This pioneering eHealth programme transforms home-based rehabilitation for preschool children with congenital heart disease, addressing a critical gap in accessible and long-term paediatric cardiac rehabilitation care.

Implications for the Profession and/or Patient Care

The use of eHealth programmes is valuable for improving paediatric cardiac rehabilitation by empowering parents, enhancing care continuity, and reducing barriers to accessing specialised services in paediatric care, especially in areas with limited medical resources.

Impact

This study establishes the first validated eHealth framework for family-centred cardiac rehabilitation in preschool children following congenital heart surgery, addressing the critically low uptake of previously home-based rehabilitation. It also provides clinicians with a scalable solution for delivering care in underserved regions lacking access to specialised cardiac services.

Reporting Method

This study adhered to the CONSORT checklist guidelines for reporting randomised controlled trials.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct, or reporting.

Trial and Protocol Registration

This study was a randomised controlled clinical trial. The research protocol was registered with the China Clinical Trial Registration Center (registration number: ChiCTR2200062022; https://www.chictr.org.cn/showproj.html?proj=174261).

Evaluating an intervention to promote access to mental healthcare for low language proficient migrants and refugees across Europe (MentalHealth4All): study protocol for a pretest-post-test cross-national survey study

Por: van Lent · L. G. G. · Hodakova · S. · Hanft-Robert · S. · Mösko · M. · Rao · C. · Kerremans · K. · Cox · A. · Lazaro Gutierrez · R. · Temizöz · O. · Mankauskiene · D. · Biel · Łucja · Di Maria · E. · Schouten · B. · MentalHealth4All consortium · Weert · Looper · Hernandez · Chen
Background

Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.

Methods and analysis

We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).

Ethics and dissemination

For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.

Registration details

The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.

Longitudinal study of infants born preterm (<33 weeks) or with a very low birth weight in the Ile de France region of France (SEV-IDF programme): cohort profile

Por: Anzelin · L. · Thiebaut · A. C. M. · Leloup · L. · Lapillonne · A. · Pierrat · V. · Tubert-Bitter · P. · Escolano · S. · Desplanques · L. · Granier · M. · Hanf · M. · study group · S.-I. · SEV-IDF study group · Desplanques · Granier · Leloup · Zupan-Simunek · Lebeaux · Mathieu · Bri
Purpose

The SEV-IDF programme aims to track infants born before 33 weeks of gestation, with very low birth weight (VLBW), neonatal encephalopathy or severe birth anomalies and perinatal disease. It employs an open, prospective, multicentric, population-based cohort approach. This report aims to describe the methodology employed to establish and manage the programme, details regarding follow-up procedures, baseline characteristics of the included infants, and highlights new research opportunities emerging from the "Suivi des Enfants Vulnérables d'Ile-de-France" (SEV-IDF) programme.

Participants

The programme aims to (1) detect developmental anomalies early, (2) improve prevention using standardised data, (3) optimise follow-up care and (4) support multidisciplinary research.

Eligible participants are infants alive at discharge from the 59 maternities with a neonatal unit of the Île-de-France (IDF) region (France). A network of 567 trained physicians monitors the children’s development at 4 months, 1 and 2 years of corrected age, and 3, 4, 5, 6 and 7 years of age. Collected data include sociodemographic, pregnancy and neonatal characteristics, and standardised child development scores.

Findings to date

The programme enrolled 21 175 participants between 2016 and 2023, with 16 461 (77.7%) having a gestational age less than 33 weeks, 1916 (9.0%) others having VLBW, 1525 (7.2%) having encephalopathy and 1273 (6.0%) having another severe birth anomaly.

Future plans

The collected data will enable the SEV-IDF scientific committee to describe high-risk infants in the IDF region, design evidence-based campaigns to improve the quality and effectiveness of the follow-up as well as conduct research on developmental anomalies in these high-risk infants. Ongoing research currently focuses on anticipating loss to follow-up and early detection of developmental anomalies.

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