Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04150120
Other study ID # 2018-01399
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date December 31, 2024

Study information

Verified date December 2022
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall aim is twofold: 1) to stretch the borderline regarding the present knowledge of clinical and economic cost-effectiveness of eHealth as an aid for facilitating and supporting self-management in families with long-term childhood illness, and 2) to develop a sustainable multidisciplinary research environment for advancing, evaluating, and implementing models of eHealth to promote self-management for children and their families. A number of clinical studies are planned for, covering different parts of paediatric healthcare. The concept of child-centred care is essential. Experienced researchers from care science, medicine, economics, technology, and social science will collaborate around common issues. Expertise on IT technology will analyse the preconditions for using IT; economic evaluations will be performed alongside clinical studies; and cultural and implementation perspectives will be used to analyse the challenges that arise from the changes in relations among children, family and professionals, which may occur as a result of the introduction of eHealth. Child health is not only important in itself. Investments in child health may also generate significant future gains, such as improved educational and labour market performance. Six complex, long-term and costly challenges in paediatric healthcare are planned for, involving eHealth technology such as interactive video consultation, pictures, on-line monitoring, and textual communication. The research follows an international framework for developing and evaluating complex interventions in healthcare. End-users (families) and relevant care providers (professionals in health and social care) will participate throughout the research process. The overall aim is certainly to analyse eHealth as an aid for facilitating and supporting self-management. However, the plan also includes the research issue whether eHealth at the same time improves the allocation of scarce health care- and societal resources.


Description:

The vision for the coming 6-year period is to establish multi-disciplinary research, designed to strengthen and advance the knowledgebase of eHealth as an aid for facilitating and supporting self-management among children with long-term illness and their families. The programme builds on interventions and implementation in three research domains: (1) eHealth to enable and promote self-management in advanced paediatric care, (2) eHealth for early diagnosis and treatment in paediatric healthcare, and (3) Co-creation of multi-disciplinary knowledge for the translation of eHealth in practice. The overall goals of the research programme are to: Evaluate, advance and implement models of eHealth to improve self-management for children and adolescents with or at risk for long-term illness and their families for better allocation of family-, healthcare- and societal resources. Increase the knowledge of cultural factors and implementation strategies to facilitate implementation processes in general, and more specifically generate theoretical and methodological models on how to successfully implement eHealth in paediatric care. Enhance the translation and integration of new research findings within eHealth into care services and the wider society by supporting healthcare professionals in their provision of evidence-based care and by translating and communicating research results to them as well as stakeholders and families. Enhance the research proficiency of junior researchers in paediatric care and eHealth nationally and internationally through collaborative approaches in both inter- and multidisciplinary groups. Two features of healthcare systems today are easily detected: 1) a trend towards more reliance on the individual and family to take active part in the healthcare process - with self-management being a keyword, and 2) great expectations regarding the potential benefits of using modern information technology in the domain of health and health care. The complex and costly needs for care of an increasing number of children with long-term illness (LTI) i.e. an illness that lasts for three months or more, generally has a slow progression, and can be controlled but not cured [1]) is one of the most critical challenge for healthcare systems all over the world. In addition to poorer health, people with LTI generally have lower educational achievements, fewer economic opportunities, and higher rates of poverty. Ensuring healthy growth and development in children is a principal concern of all societies. In this context, eHealth is of special interest as an aid for facilitating and supporting self-management for children with and at risk for LTI. Self-management is the use of own time and money for individual and family health promotion. It is an ingredient in almost all measures for promoting health. Pure self-management in health relies on own efforts without formal intervention of health care services. On the other extreme, there are formal healthcare activities that require 100 percent of healthcare inputs for example surgery under anaesthesia. In most instances, both types of inputs are necessary - in varying degrees. The choice of self-management activities and its results depend on family-member preferences, knowledge, and attitudes. In order for healthcare system initiatives to be accepted and successful, they must be attuned to these characteristics. Individual tailoring is all the more important, the more reliance is on self-management. Thus, in the process of developing and evaluating new treatment modes, user participation is essential. eHealth is a broad concept as indicated by the WHO definition: "eHealth is the transfer of health resources and healthcare by electronic means", i.e. also including older techniques such as telemedicine. Great expectations are associated with the realisation of the term. It may: 1) increase communication between healthcare providers and patients, 2) increase accessibility and patient participation in healthcare, and 3) support information and data sharing between patients, family and health-service providers http://www.euro.who.int/en/ehealth. It might be observed that the term eHealth does not preclude the use of electronic means to improve communication between providers within the healthcare system, potentially increasing the internal efficiency of formal healthcare, without any direct effects on patients and families. Here, however, the focus is on the role of eHealth as an aid for facilitating and supporting self-management, i.e. a concern with a wider, societal perspective on the allocation of scarce resources for health. Cost-effectiveness is one of the ethical principles that are supposed to govern decisions on the allocation of scarce healthcare resources in Sweden. Thus, new healthcare technology should not be introduced if not proven cost-effective in comparison to existing (best) practice. Requirements for the economic evaluation of new healthcare technology exist in most Western countries. To date, economic evaluations of eHealth reported in the literature are scare and suffer from lack of randomised control trials (RTCs), small sample sizes, and the absence of high-quality data or appropriate measures. Paediatric healthcare is rapidly evolving towards outpatient and community-care and from public to parental responsibility. This form of care is however rarely backed-up with communication support. In Sweden and most Western countries, highly specialised paediatric healthcare is confined to few National Centres of Specialized Medicine (NCSM) http://www.socialstyrelsen.se/rikssjukvard. This means that following birth a large majority of children with congenital malformations are transported to hospitals far away from home for advanced surgery. Following discharge, the outermost medical and nursing competence for the child will be at the NCSM. International policy and practice aim for infants, older children and adolescents with LTI to be cared for at home as much as possible to reduce the distress of hospital admissions and to keep up the normal family life. Limited research exists on the effect of digital interactive care on parents and children. eHealth in the home setting is often preferred by parents, especially by parents of newborns but has still not been widely adopted. Digital techniques can aid safer post-operative healthcare at home and may reduce costs to patients and society. This in turn might lead to more confident use of self-management and an increased sense of security at home. In some areas in paediatric care telemedicine initiatives is shown to benefit resources, enrich the community, and improve care that ultimately serve to better patient health. Six clinical research projects are planned, illustrating complex, highly specialized, often long-term and costly decision-making challenges in paediatric care, for developing, evaluating implementing, and utilising different devices of eHealth technology. In addition, four more research projects will be performed in parallel to provide general analyses of eHealth in paediatric care and to facilitate and support economic, technical, cultural, and organisational analyses of the clinical data. Bridging the hospital care and safe care at home for children with LTI with the aid of eHealth is a vital clinical area, especially for professionals in nursing, physiotherapy and medicine. However, also for the scientific area in health science it is of great importance as eHealth change the communication between children, parents and health professionals. This is a new research area that needs to be explored. To develop, evaluate and implement eHealth devices in clinical care, an inter- and multidisciplinary approach is needed. Therefore, the investigators well-functioning and long-lasting clinical and research collaboration in health science, medicine, global health, health economics, technology, and social science has been enhanced to respond to the needs in paediatric care. Thereby, it is possible to address the important study of encounters with technology and various methods of communications and how eHealth aid can capture complex exchange of wellbeing and health, and feelings and perceptions of for example anxiety, stress levels, safety, many of which are culturally related. Also, values and contexts are sensitive to communication methods. The studies will therefore contribute significantly to the research area of eHealth as an aid for facilitating and supporting self-management in paediatric care, but not only. The programme also includes the research issue whether eHealth at the same time improves the allocation of scarce healthcare- and societal resources. The multi-method design including both qualitative and quantitative methods will enhance the understanding to advance and evaluate routines and practices for better physiological and psychological outcomes in children with LTI and their families. The clinical projects will also contribute to a deeper understanding on identifying risk factors for complications and how to prevent adverse events in care performed at home. In this programme, the focus is on eHealth solutions for situations where children and their families can be supported by enhanced communication for self-management with specialist professionals most commonly with specialist nurses. In such situations, it is important to find technical solutions that are both easy to use for all involved, easily accessible for families, and efficient to use for the professionals. Design options include web browser-based solutions, application-based solutions for larger mobile devices such as touchpads and application for mobile phones while observing the strict security rules for personal health information. An issue of accessibility is also to avoid economic demands on e.g. families not having access to appropriate equipment. Furthermore, relying on patient's equipment increases the technical demand and testing as the variation of equipment is huge, while the number of patients is comparatively small. Typically, technologies and applications develop at a high pace driven by commercial interests and may not be synchronised with a corresponding development of the understanding of possibilities and limitations of the applications in specific areas of care. Importantly, the studies within different clinical contexts and considering cost-effectiveness, technical development, cultural and implementation aspects contribute to the knowledge and understanding about how eHealth can reduce the information asymmetry between providers, developers and consumers for further implementation into clinical practices, policies, and procedures. This programme also provides a significant contribution to a grounded and evidence-based understanding of both possibilities and limitations of eHealth applications in this area not only in terms of their efficacy but also in terms of the possible ethical conflicts involved in the introduction of new technology.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 420
Est. completion date December 31, 2024
Est. primary completion date October 15, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Days to 47 Months
Eligibility Inclusion Criteria (Intervention group): Legal guardians of children below four years of age who are hospitalised for: - reconstructive surgery for congenital malformations - cardiac surgery for CHD - premature birth - paediatric cancer and in treatment - are in need of nutritional supplements - are about to be discharged from the hospital - are able to communicate in the local language (Swedish in Sweden and Danish in Denmark) - signs informed consent Inclusion Criteria (Control group): Legal guardians of children below four years of age who fulfil the intervention group inclusion criteria but: - do not want to use the e-device - not recruited for the intervention group - are recruited after the stipulated numbers for the intervention group are met Exclusion Criteria: - Legal guardians of children fulfilling the inclusion criteria but where the child has complications or comorbidity which may affect the results of the study (as defined by the responsible medical physician) - The legal guardian refuses to sign informed consent.

Study Design


Intervention

Device:
e-health device with application
In this project we focus on eHealth solutions for patients and/or their families in situations where they could benefit from enhanced communication options with specialist staff. In this design space we use a model where a 4G-enabled tablet computer is lent to the families for the length of the study, thus avoiding economic requirements on the families and keeping the equipment uniform. The tablets run an application that enables multiple forms of direct and bi-directional communication in real-time with specialist staff at the hospital. For the staff, the technical situation is different; here we have in earlier demonstrators used web-based solutions accessed with existing computer equipment.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen
Denmark Hillerød Hospital Hillerød
Sweden Neonatal Department, Skåne University Hospital Lund Skåne
Sweden Paediatric Cardiology Department, Skåne University Hospital Lund Skåne
Sweden Paediatric Oncology Department, Skåne University Hospital Lund Skåne
Sweden Paediatric Surgery Department, Skåne University Hospital Lund Skåne

Sponsors (5)

Lead Sponsor Collaborator
Lund University Arba Minch University, Rigshospitalet, Denmark, Skane University Hospital, University of Iceland

Countries where clinical trial is conducted

Denmark,  Sweden, 

References & Publications (47)

Abidin, R., Parenting Stress Index, in Professional Manual. 1995, Psychological Assessment Resources, Inc: Odessa.

Berry, J.W., et al., Cross-cultural psychology: Research and applications. 3 ed. 2011, Cambridge, UK: Cambridge Univ Press.

Biru M, Hallstrom I, Lundqvist P, Jerene D. Rates and predictors of attrition among children on antiretroviral therapy in Ethiopia: A prospective cohort study. PLoS One. 2018 Feb 6;13(2):e0189777. doi: 10.1371/journal.pone.0189777. eCollection 2018. — View Citation

Black AK, Sadanala UK, Mascio CE, Hornung CA, Keller BB. Challenges in implementing a pediatric cardiovascular home telehealth project. Telemed J E Health. 2014 Sep;20(9):858-67. doi: 10.1089/tmj.2013.0343. Epub 2014 Aug 1. — View Citation

Bolin K, Jacobson L, Lindgren B. The family as the health producer--when spouses are Nash-bargainers. J Health Econ. 2001 May;20(3):349-62. doi: 10.1016/s0167-6296(00)00086-2. — View Citation

Bradford NK, Young J, Armfield NR, Herbert A, Smith AC. Home telehealth and paediatric palliative care: clinician perceptions of what is stopping us? BMC Palliat Care. 2014 Jun 16;13:29. doi: 10.1186/1472-684X-13-29. eCollection 2014. — View Citation

Brown AK, Greisen G, Haugsted U, Jonsbo F. Formal training in general movement assessment is required to effectively evaluate infants with perinatal asphyxia in outpatient settings. Acta Paediatr. 2016 Sep;105(9):1056-60. doi: 10.1111/apa.13491. Epub 2016 Jun 24. — View Citation

Chan CV, Kaufman DR. A framework for characterizing eHealth literacy demands and barriers. J Med Internet Res. 2011 Nov 17;13(4):e94. doi: 10.2196/jmir.1750. — View Citation

Chernick, M., Bootstrap Methods: A Practitioner's Guide. . 1999, New York: John Wiley & Sons.

Coyne I, Hallstrom I, Soderback M. Reframing the focus from a family-centred to a child-centred care approach for children's healthcare. J Child Health Care. 2016 Dec;20(4):494-502. doi: 10.1177/1367493516642744. Epub 2016 Jul 25. — View Citation

Craft MJ, Willadsen JA. Interventions related to family. Nurs Clin North Am. 1992 Jun;27(2):517-40. — View Citation

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655. — View Citation

Creswell, J. and V. Plano Clark, Designing and conducting mixed methods research. 2011, Thousand Oaks, CA: Sage.

Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013 May 10;8:51. doi: 10.1186/1748-5908-8-51. — View Citation

Danbjorg DB, Wagner L, Kristensen BR, Clemensen J. Intervention among new parents followed up by an interview study exploring their experiences of telemedicine after early postnatal discharge. Midwifery. 2015 Jun;31(6):574-81. doi: 10.1016/j.midw.2015.02.007. Epub 2015 Feb 24. — View Citation

de la Torre-Diez I, Lopez-Coronado M, Vaca C, Aguado JS, de Castro C. Cost-utility and cost-effectiveness studies of telemedicine, electronic, and mobile health systems in the literature: a systematic review. Telemed J E Health. 2015 Feb;21(2):81-5. doi: 10.1089/tmj.2014.0053. Epub 2014 Dec 4. — View Citation

Flores G; Committee On Pediatric Research. Technical report--racial and ethnic disparities in the health and health care of children. Pediatrics. 2010 Apr;125(4):e979-e1020. doi: 10.1542/peds.2010-0188. Epub 2010 Mar 29. — View Citation

Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001. — View Citation

Graneli C, Dahlin E, Borjesson A, Arnbjornsson E, Stenstrom P. Diagnosis, Symptoms, and Outcomes of Hirschsprung's Disease from the Perspective of Gender. Surg Res Pract. 2017;2017:9274940. doi: 10.1155/2017/9274940. Epub 2017 Mar 7. — View Citation

Grossman, M., The Determinants of Health: An Economic Perspective. 2017, New York: Columbia University Press

Hall, E.C.O., et al., The journey towards motherhood after a very preterm birth: Mothers' experiences in hospital and after home-coming. Journal of Neonatal Nursing, 2013. 19(3): p. 109-113.

Hansson H, Kjaergaard H, Johansen C, Hallstrom I, Christensen J, Madsen M, Schmiegelow K. Hospital-based home care for children with cancer: feasibility and psychosocial impact on children and their families. Pediatr Blood Cancer. 2013 May;60(5):865-72. doi: 10.1002/pbc.24474. Epub 2013 Jan 17. — View Citation

Hearps SJ, McCarthy MC, Muscara F, Hearps SJ, Burke K, Jones B, Anderson VA. Psychosocial risk in families of infants undergoing surgery for a serious congenital heart disease. Cardiol Young. 2014 Aug;24(4):632-9. doi: 10.1017/S1047951113000760. Epub 2013 Jun 27. — View Citation

Heckman JJ. The developmental origins of health. Health Econ. 2012 Jan;21(1):24-9. doi: 10.1002/hec.1802. — View Citation

Holmberg, R., et al., Leadership and implementation of evidence-based practices. . Leadership in Health Services, 2008. 21(3): p. 168-184.

Johannesson. and Perjsons., An Introduction to Design Science. 2014: Springer.

Johnsson, B. and B. Magnusson, Supporting Collaborative Healthcare Using PalCom - The itACiH System, in Seventh International Workshop on Pervasive Collaboration and Social Networking. 2016: Sydney, Australia.

Johnsson, B.A., M. Nordahl, and B. Magnusson, Evaluating a Dynamic Keep-Alive Messaging Strategy for Mobile Pervasive Systems. Procedia Computer Science, 2017. 109: p. 319-326.

Kristjansdottir O, Unruh AM, McAlpine L, McGrath PJ. A systematic review of cross-cultural comparison studies of child, parent, and health professional outcomes associated with pediatric medical procedures. J Pain. 2012 Mar;13(3):207-19. doi: 10.1016/j.jpain.2011.12.008. — View Citation

Lundqvist, P., Children born prematurely : their fathers' experiences and trends in mortality and morbidity during a ten-year period. Lund University, Faculty of Medicine doctoral dissertation series: 2008:117. 2008: Lund : Lund University, 2008.

Mansson C, Jakobsson U, Lundqvist P. Translation and psychometric evaluation of a Swedish version of the parental stressor scale PSS: NICU. Scand J Caring Sci. 2016 Mar;30(1):193-201. doi: 10.1111/scs.12217. Epub 2015 Apr 28. — View Citation

Marklund B, Strom M, Mansson J, Borgquist L, Baigi A, Fridlund B. Computer-supported telephone nurse triage: an evaluation of medical quality and costs. J Nurs Manag. 2007 Mar;15(2):180-7. doi: 10.1111/j.1365-2834.2007.00659.x. — View Citation

Miller GG, Levesque K. Telehealth provides effective pediatric surgery care to remote locations. J Pediatr Surg. 2002 May;37(5):752-4. doi: 10.1053/jpsu.2002.32270. — View Citation

Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27. — View Citation

Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8. — View Citation

Ost E, Nisell M, Frenckner B, Mesas Burgos C, Ojmyr-Joelsson M. Parenting stress among parents of children with congenital diaphragmatic hernia. Pediatr Surg Int. 2017 Jul;33(7):761-769. doi: 10.1007/s00383-017-4093-4. Epub 2017 May 19. — View Citation

Parab CS, Cooper C, Woolfenden S, Piper SM. Specialist home-based nursing services for children with acute and chronic illnesses. Cochrane Database Syst Rev. 2013 Jun 15;2013(6):CD004383. doi: 10.1002/14651858.CD004383.pub3. — View Citation

Perrin EC, Newacheck P, Pless IB, Drotar D, Gortmaker SL, Leventhal J, Perrin JM, Stein RE, Walker DK, Weitzman M. Issues involved in the definition and classification of chronic health conditions. Pediatrics. 1993 Apr;91(4):787-93. — View Citation

Phares V, Lopez E, Fields S, Kamboukos D, Duhig AM. Are fathers involved in pediatric psychology research and treatment? J Pediatr Psychol. 2005 Dec;30(8):631-43. doi: 10.1093/jpepsy/jsi050. Epub 2005 Mar 16. — View Citation

Ross J, Stevenson F, Lau R, Murray E. Factors that influence the implementation of e-health: a systematic review of systematic reviews (an update). Implement Sci. 2016 Oct 26;11(1):146. doi: 10.1186/s13012-016-0510-7. — View Citation

Sjostrom-Strand A, Terp K. Parents' Experiences of Having a Baby With a Congenital Heart Defect and the Child's Heart Surgery. Compr Child Adolesc Nurs. 2019 Mar;42(1):10-23. doi: 10.1080/24694193.2017.1342104. Epub 2017 Aug 8. — View Citation

Stone JM, Gibbons TE. Telemedicine in Pediatric Gastroenterology: An Overview of Utility. Telemed J E Health. 2018 Aug;24(8):577-581. doi: 10.1089/tmj.2017.0234. Epub 2017 Dec 22. — View Citation

Tan K, Lai NM. Telemedicine for the support of parents of high-risk newborn infants. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD006818. doi: 10.1002/14651858.CD006818.pub2. — View Citation

Tiberg, I., The initial care when a child is diagnosed with type 1 diabetes. Doctoral dissertation series /Faculty of Medicine, Lund University: 2012:48. 2012: Lund : Faculty of Medicin, Lund University, 2012.

Walsh KE, Roblin DW, Weingart SN, Houlahan KE, Degar B, Billett A, Keuker C, Biggins C, Li J, Wasilewski K, Mazor KM. Medication errors in the home: a multisite study of children with cancer. Pediatrics. 2013 May;131(5):e1405-14. doi: 10.1542/peds.2012-2434. Epub 2013 Apr 29. — View Citation

Weiss, D. and C. Marmar, Assessing Psychological Trauma and PTSD in The Impact of Event Scale-Revised, W. JP and K. TM, Editors. 1997, Guilford Press: New York. p. 399-411.

World report on disability. 2011; Available from: http://www.who.int/disabilities/world_report/2011/en/.

* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The PedsQL Healthcare Satisfaction Generic Module The PedsQL Healthcare Satisfaction Generic Module is composed of 24 items comprising 6 dimensions. Item scaling: 5-point Likert scale: 0 (Never) to 4 (Always) and Not Applicable. Higher scores indicate higher satisfaction. The scale includes the variables: information, family inclusion, communication, technical skills, emotional needs, and overall satisfaction. After their participation in the study has ended, on average after 2-4 weeks.
Primary Cost-utility ratios Health economic variables After their participation in the study has ended, on average after 2-4 weeks.
Secondary The child's general and specific health status This questionnaire contains information about the health of each child both at the time when the study begins and when the study ends. It asks for information on the weight of the child, the diagnosis, the treatment, specific needs when released from hospital, general health status when released from hospital, general health status at end of study. The answers are either given as multiple choice or as free text. Before the study begins and after their participation in the study has ended, on average after 2-4 weeks.
Secondary The PedsQL 2.0 Family Impact Module The PedsQL 2.0 Family Impact Module is composed of 36 items comprising 8 dimensions. Item scaling: 5-point Likert scale: 5-point Likert scale from 0 (Never) to 4 (Almost always). Higher scores indicate better functioning. After their participation in the study has ended, on average after 2-4 weeks.
Secondary The Parental Stress (Parental - Persistent Role Problems) The Parental Stress (Parental - Persistent Role Problems) is composed of 9 items. Item scaling: 5-point Likert scale: 5-point Likert scale from 0 (Does not happen) to 4 (Happens always). Lower scores indicate less stress. After their participation in the study has ended, on average after 2-4 weeks.
Secondary Adverse events that occurs during the study period Any adverse events occurring during the study period will be recorded in free text format by the staff for all participants. After their participation in the study has ended, on average after 2-4 weeks.
Secondary The Clavien-Dindo Classification The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. The scale consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). A high grade indicates a more severe problem. After their participation in the study has ended, on average after 2-4 weeks.
Secondary Length of hospital stay Days After their participation in the study has ended, on average after 2-4 weeks.
Secondary Number of routine and acute visits Number of routine and acute visits After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Family time Distribution of family time use After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Family economy Family economy After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Hopsital resources Use of hospital resources After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Health care resources Use of other healthcare resources After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Health care expenditures Healthcare expenditures by type of resource After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Productivity Loss of production After their participation in the study has ended, on average after 2-4 weeks.
Secondary Health economic variables: Utility Utility scores. After their participation in the study has ended, on average after 2-4 weeks.
Secondary EQ-5D-3L The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. After their participation in the study has ended, on average after 2-4 weeks.
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04992793 - Paediatric Brain Injury Following Cardiac Interventions
Recruiting NCT05213598 - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed NCT04136379 - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed NCT04814888 - 3D Airway Model for Pediatric Patients
Recruiting NCT04920643 - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery N/A
Completed NCT05934578 - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training N/A
Recruiting NCT06041685 - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Not yet recruiting NCT05687292 - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting NCT05524324 - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT N/A
Completed NCT02746029 - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed NCT03119090 - Fontan Imaging Biomarkers (FIB) Study
Completed NCT02537392 - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease N/A
Recruiting NCT02258724 - Swiss National Registry of Grown up Congenital Heart Disease Patients
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
Recruiting NCT01184404 - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery N/A
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A

External Links