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eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness (eChildHealth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150120
Recruitment Status : Enrolling by invitation
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborators:
Skane University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Inger Kristensson Hallström, Lund University

Brief 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.


Condition or disease Intervention/treatment Phase
Preterm Birth Pediatric Cancer Hirschsprung Disease Congenital Malformation Congenital Heart Disease Nutrition Disorder, Child Device: e-health device with application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consecutive series of legal guardians to children fulfilling the inclusion criteria in each arm. The legal guardians will be asked to 1) be involved in the development of the eHealth application, 2) evaluate the eHealth application at home, or 3) serve as a control group receiving traditional follow-up after discharge.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness - Development, Evaluation and Implementation in Clinical Practice
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Active Comparator: Reconstructive paediatric surgery (Area I)
The overall incidence of congenital malformations in the gastrointestinal and urinary tract needing surgical interventions is about 1:1000 (Swedish national malformation registers) with a morbidity during childhood about 20-60%. Advanced paediatric surgery for the diagnosis Hirschsprung's disease, anorectal malformations, bladder extrophy, congenital diaphragmal hernia, and esophageal atresia is from July 2018 only performed at two NCSM in Sweden. The NCSM at Skåne University Hospital (SUS) in Lund forms one context. The quality of postoperative care is of immense importance both for short and long-term outcome. Legal guardians describe their situation after leaving the hospital as extremely stressful as they have not only to take responsibility for their new-born child but also of surgical wounds, medications, treatments, and special nutritional needs.
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.

Active Comparator: Congenital heart disease (Area II)
In Sweden, about 8-10 in 1000 children per year are born with congenital heart disease (CHD). CHD is a birth defect that leads to frequent hospitalisation, long hospital stays, and extreme anxiety for parents (18). In Sweden, paediatric heart surgery is concentrated to two NCSM of which one is situated at SUS, Lund where 250-300 children have cardiac surgery every year. Children with complicated CHD require contact and follow-up visits for a long time after the heart surgery and many families have to travel long for surgery (for example from Iceland), postoperative care and follow-up visits. Telemedicine after reconstructive cardiac surgery in children is shown to be feasible, although challenging and reduced unscheduled visits.
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.

Active Comparator: Preterm born (Area III)
Most prematurely born children grow up to be healthy, but as a group, they are at a greater risk of developing cognitive, emotional and behavioural problems. Every year 7% of all children are born prematurely (gestational age of less than 37 weeks) and the numbers of preterm births are rising in Sweden as well as internationally. Preterm births often involve long hospitalisations for children and parents, and discharge from the hospital often means a difficult transition for parents in both short and long-term perspectives. Traditionally, communication with parents following discharge has been through home visits or telephone calls. By communicating through digital technology, it may be possible to improve the support to parents and thereby make the transition from hospital to home less stressful.
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.

Active Comparator: Paediatric oncology (Area IV)
For children with cancer, treatment and follow-up at home is common. At the same time, families wish to minimize the negative impact on family members' social and everyday life. Home medication management is a high-risk area and medication errors are common, particularly among parents of children with cancer. Thus, parents are responsible for complex care and regular follow-up in their home with an increased need for education as well as clinical management support. At present, there are no, or limited, professional outreach support to support them and their families. Communication with parents following discharge has been through e-mail and/ or telephone calls. By communicating through digital technology, it may be possible to improve the support to children and parents.
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.

Active Comparator: Intravenous infusion therapy at home (Area V)
For children with LTI administration of intravenous infusion therapy at home is an increasingly important area. Home medication management is a high-risk area and medication errors are common, particularly among parents of children with cancer. Thus, parents are responsible for complex care in their home with an increased need for educational as well as clinical management support during home infusion therapy. At present, children and adolescents with LTI at the University Hospital of Copenhagen receive home infusion therapy by a portable pump with no assistance from an outreaching team to support them and their families.
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.

Active Comparator: Children with cerebral palsy (VI)
Cerebral palsy (CP) is the most common physical disability in childhood. Approximately 2-2.5/1000 children have CP with affected muscle tone, movement and motor skills, often accompanied by pain, epilepsy and intellectual, communicational and behavioural impairment. Early detection is challenging but important for minimizing the consequences from neurodevelopmental impairment by an early and right treatment. General Movement Assessment (GMA), an observational method for classification of spontaneous movements in young infants, is currently the most accurate method for early identification of CP. Video recordings are taken with a standardised video set-up in the hospitals regular follow-up clinics when the child is 10 to 20 weeks post-term age. Performing video recordings at home by the parents at a time, which suits the family and the child, would optimize the chances for a successful recording.
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.




Primary Outcome Measures :
  1. The PedsQL Healthcare Satisfaction Generic Module [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    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.

  2. Cost-utility ratios [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Health economic variables


Secondary Outcome Measures :
  1. The child's general and specific health status [ Time Frame: Before the study begins and after their participation in the study has ended, on average after 2-4 weeks. ]
    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.

  2. The PedsQL 2.0 Family Impact Module [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    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.

  3. The Parental Stress (Parental - Persistent Role Problems) [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    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.

  4. Adverse events that occurs during the study period [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Any adverse events occurring during the study period will be recorded in free text format by the staff for all participants.

  5. The Clavien-Dindo Classification [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    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.

  6. Length of hospital stay [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Days

  7. Number of routine and acute visits [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Number of routine and acute visits

  8. Health economic variables: Family time [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Distribution of family time use

  9. Health economic variables: Family economy [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Family economy

  10. Health economic variables: Hopsital resources [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Use of hospital resources

  11. Health economic variables: Health care resources [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Use of other healthcare resources

  12. Health economic variables: Health care expenditures [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Healthcare expenditures by type of resource

  13. Health economic variables: Productivity [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Loss of production

  14. Health economic variables: Utility [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    Utility scores.

  15. EQ-5D-3L [ Time Frame: After their participation in the study has ended, on average after 2-4 weeks. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150120


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark
Hillerød Hospital
Hillerød, Denmark
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, Sweden
Sponsors and Collaborators
Lund University
Skane University Hospital
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Inger Kristensson Hallström, PhD Lund University
Additional Information:
Publications:
World report on disability. 2011; Available from: http://www.who.int/disabilities/world_report/2011/en/.
Grossman, M., The Determinants of Health: An Economic Perspective. 2017, New York: Columbia University Press
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.
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.
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.
Johannesson. and Perjsons., An Introduction to Design Science. 2014: Springer.
Creswell, J. and V. Plano Clark, Designing and conducting mixed methods research. 2011, Thousand Oaks, CA: Sage.
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.
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.
Chernick, M., Bootstrap Methods: A Practitioner's Guide. . 1999, New York: John Wiley & Sons.
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.
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.
Holmberg, R., et al., Leadership and implementation of evidence-based practices. . Leadership in Health Services, 2008. 21(3): p. 168-184.

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Responsible Party: Inger Kristensson Hallström, Professor, Lund University
ClinicalTrials.gov Identifier: NCT04150120    
Other Study ID Numbers: 2018-01399
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inger Kristensson Hallström, Lund University:
e-health
children
culture
health economy
quality of life
home care
Additional relevant MeSH terms:
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Hirschsprung Disease
Premature Birth
Heart Diseases
Congenital Abnormalities
Nutrition Disorders
Child Nutrition Disorders
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases