scholarly journals CHIP-Family intervention to improve the psychosocial well-being of young children with congenital heart disease and their families: results of a randomised controlled trial

2019 ◽  
Vol 29 (09) ◽  
pp. 1172-1182 ◽  
Author(s):  
Malindi van der Mheen ◽  
Maya G. Meentken ◽  
Ingrid M. van Beynum ◽  
Jan van der Ende ◽  
Eugène van Galen ◽  
...  
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Randomised Controlled Trial ◽  
Congenital Heart ◽  
Controlled Trial ◽  
Psychosocial Problems ◽  
School Functioning ◽  
Trial Registry ◽  
Randomised Controlled

AbstractObjective:Children with congenital heart disease and their families are at risk of psychosocial problems. Emotional and behavioural problems, impaired school functioning, and reduced exercise capacity often occur. To prevent and decrease these problems, we modified and extended the previously established Congenital Heart Disease Intervention Program (CHIP)–School, thereby creating CHIP-Family. CHIP-Family is the first psychosocial intervention with a module for children with congenital heart disease. Through a randomised controlled trial, we examined the effectiveness of CHIP-Family.Methods:Ninety-three children with congenital heart disease (age M = 5.34 years, SD = 1.27) were randomised to CHIP-Family (n = 49) or care as usual (no psychosocial care; n = 44). CHIP-Family consisted of a 1-day group workshop for parents, children, and siblings and an individual follow-up session for parents. CHIP-Family was delivered by psychologists, paediatric cardiologists, and physiotherapists. At baseline and 6-month follow-up, mothers, fathers, teachers, and the child completed questionnaires to assess psychosocial problems, school functioning, and sports enjoyment. Moreover, at 6-month follow-up, parents completed program satisfaction assessments.Results:Although small improvements in child outcomes were observed in the CHIP-Family group, no statistically significant differences were found between outcomes of the CHIP-Family and care-as-usual group. Mean parent satisfaction ratings ranged from 7.4 to 8.1 (range 0–10).Conclusions:CHIP-Family yielded high program acceptability ratings. However, compared to care as usual, CHIP-Family did not find the same extent of statistically significant outcomes as CHIP-School. Replication of promising psychological interventions, and examination of when different outcomes are found, is recommended for refining interventions in the future.Trial registryDutch Trial Registry number NTR6063, https://www.trialregister.nl/trial/5780.

scholarly journals Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Oscar Werner ◽  
Charlene Bredy ◽  
Kathleen Lavastre ◽  
Sophie Guillaumont ◽  
Gregoire De La Villeon ◽  
...  
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Education Program ◽  
Congenital Heart ◽  
Therapeutic Education ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

Abstract Background Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Until recently, more than 50% of these patients were lost to follow up because of the lack of specialized structures. The critical moment is the transition between paediatric and adult unit. Therapeutic education is crucial to solve this issue by helping patients to become independent and responsible. The TRANSITION-CHD randomized trial aims to assess the impact of a transition education program on health-related quality of life (HRQoL) of adolescents and young adults with CHD. Methods Multicentre, randomised, controlled, parallel arm study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (education program vs. no intervention). The primary outcome is the change in self-reported HRQoL between baseline and 12-month follow-up. A total of 100 patients in each group is required to observe a significant increase of the overall HRQoL score of 7 ± 13.5 points (on 100) with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (peak VO2, VAT, VE/VCO2 slope), level of knowledge of the disease using the Leuven knowledge questionnaire for CHD, physical and psychological status. Discussion As the current research is opening on patient related outcomes, and as the level of proof in therapeutic education is still low, we sought to assess the efficacy of a therapeutic education program on HRQoL of CHD patients with a randomized trial. Trial registration This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).

scholarly journals Impact of a Transition Education Program on the Quality of Life in Pediatric Patients with Congenital Heart Disease: Study Design for a Randomised Controlled Trial

2020 ◽  
Author(s):  
Oscar werner ◽  
Charlene Bredy ◽  
Kathleen LAVASTRE ◽  
Sophie Guillaumont ◽  
Gregoire De LA VILLEON ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Congenital Heart Disease ◽  
Heart Disease ◽  
Randomized Trial ◽  
Education Program ◽  
Congenital Heart ◽  
Therapeutic Education ◽  
Randomised Controlled

Abstract Background: Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Until recently, more than 50% of these patients were lost to follow up because of the lack of specialized structures. The critical moment is the transition between paediatric and adult unit. Therapeutic education is crucial to solve this issue by helping patient to become independent and responsible. The TRANSITION randomized trial aims to assess the impact of a transition education program on the quality of life (QoL) of adolescents and young adults with CHD. Methods: multicentre, randomised, controlled, parallel arm study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (Education program vs. no intervention). The primary outcome is the change in self-reported QoL between baseline and 12-month follow-up. A total of 100 patients in each group is required to observe a significant increase of the overall QoL score of 7±13.5 points (on 100) with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (VO2max,VE/VCO2 slope), level of knowledge, physical and psychological status.Discussion: As the current research is opening on patient related outcomes, and as the level of proof in therapeutic education still low, we sought to assess the efficacy of a therapeutic education program on the QoL of CHD patients with a randomized trial.Trial registration: This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626) on 29th December 2016

scholarly journals Propensity weighting: how to minimise comparative bias in non-randomised studies?

2019 ◽  
Vol 19 (1) ◽  
pp. 83-88 ◽  
Author(s):  
Philip Moons
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Trial Design ◽  
Congenital Heart ◽  
Controlled Trial ◽  
Randomised Study ◽  
Cannabis Consumption ◽  
Randomised Controlled ◽  
Study Designs ◽  
Cardiovascular Nursing

Non-randomised study designs are frequently used by researchers in cardiovascular nursing and allied professions. Baseline differences between the groups to be compared may introduce bias in the results. Methods for causal inference address this issue. One such method is propensity weighting, in which two or more treatments/exposure groups are weighted to make the groups as comparable as possible. As such, it mimics a randomised controlled trial design. In this article, the Twang package is presented for propensity weighting, and its use is exemplified in a study on smoking and cannabis consumption in adults with congenital heart disease.

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