NCT04150120 — eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness · CancerIndex
Clinical trial · Interventional
eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness
eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness - Development, Evaluation and Implementation in Clinical Practice
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
early detection of cerebral palsy using a mobile phone application
Device
—
UNRESOLVED
e-health device with application
Device
—
UNRESOLVED
Mobile phone text messaging
Device
—
UNRESOLVED
Self-care for children with intravenous treatment at home
Device
—
UNRESOLVED
Design
Arms and outcomes
Arms (7)
type
ACTIVE_COMPARATOR
label
Reconstructive paediatric surgery (Area I)
description
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.
interventionNames
Device: e-health device with application
type
ACTIVE_COMPARATOR
label
Congenital heart disease (Area II)
description
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.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
3 Days
Maximum age
19 Years
Show eligibility criteria text
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
For the Ethiopian arm:
Adolescents, aged 15-19, living with HIV and currently enrolled in ART care for two years or less, being able to read the local language and willing to participate in the study will be eligible for the study.
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
For the Ethiopian arm:
Adolescents, aged 15-19, living with HIV and currently enrolled in ART care for two years or less, being able to read the local language and willing to participate in the study will be eligible for the study.
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.
For the Ethiopian arm:
Patients outside of the specified age and adolescents, who are in patient-department, and adolescents who cannot read.
References
Publications (52)
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interventionNames
Device: e-health device with application
type
ACTIVE_COMPARATOR
label
Preterm born (Area III)
description
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.
interventionNames
Device: e-health device with application
type
ACTIVE_COMPARATOR
label
Paediatric oncology (Area IV)
description
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.
interventionNames
Device: e-health device with application
type
ACTIVE_COMPARATOR
label
Intravenous infusion therapy at home (Area V)
description
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.
interventionNames
Device: Self-care for children with intravenous treatment at home
type
ACTIVE_COMPARATOR
label
Children with cerebral palsy (VI)
description
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.
interventionNames
Device: early detection of cerebral palsy using a mobile phone application
type
ACTIVE_COMPARATOR
label
Adherence to and retention in HIV care among adolescents (VII)
description
Adolescents living with HIV constitute key affected population groups in Ethiopia with HIV being the second cause of death among adolescents in the country. Adherence to antiretroviral therapy (ART) is critical to ensure the effectiveness of HIV treatment; high levels of adherence have been consistently associated with improved virologic, immunologic, and clinical outcomes with a consequent increase in survival and quality of life. Thus, the overall purpose of this project is to increase HIV positive adolescent's adherence to ART and retention in care thereby to better prolong their lives.
interventionNames
Device: Mobile phone text messaging
Primary outcomes (6)
measure
The PedsQL Healthcare Satisfaction Generic Module
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
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.
measure
Cost-utility ratios
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Health economic variables
measure
Retention in care
timeFrame
Follow-up at three and six months after baseline.
description
Medical follow-up questionnaire
measure
Adherence to treatment
timeFrame
Follow-up at three and six months after baseline.
description
Medical follow-up questionnaire
measure
Qualitative data collection
timeFrame
Ongoing data collection until 2024
description
Interviews with parents and caregivers.
measure
General Movement Assessment vs standardized questionnaires
timeFrame
During the neonatal period (0-22 weeks) and at six months of age
description
Comparison of General Movement Assessment with standardized questionnaires looking for change between the neonatal period (uptil week 22) and at six months of age.
Secondary outcomes (15)
measure
The child's general and specific health status
timeFrame
Before the study begins and after their participation in the study has ended, on average after 2-4 weeks.
description
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.
measure
The PedsQL 2.0 Family Impact Module
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
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.
measure
The Parental Stress (Parental - Persistent Role Problems)
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
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.
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DERIVEDAvik Persson H, Castor C, Andersson N, Hylen M. Swedish Version of the System Usability Scale: Translation, Adaption, and Psychometric Evaluation. JMIR Hum Factors. 2025 Jan 16;12:e64210. doi: 10.2196/64210. PMID 39819595
DERIVEDFoldager Jeppesen S, Vilhjalmsson R, Avik Persson H, Kristensson Hallstrom I. Parental satisfaction with paediatric care with and without the support of an eHealth device: a quasi-experimental study in Sweden. BMC Health Serv Res. 2024 Jan 9;24(1):41. doi: 10.1186/s12913-023-10398-7. PMID 38195486
DERIVEDDerwig M, Lindkvist RM, Hallstrom IK, Johnsson BA, Stenstrom P. eHealth usage among parents to premature or surgically treated neonates: associations with eHealth literacy, healthcare satisfaction or satisfaction with an eHealth device. BMC Pediatr. 2023 Oct 21;23(1):524. doi: 10.1186/s12887-023-04340-3. PMID 37865736
DERIVEDCastor C, Lindkvist RM, Hallstrom IK, Holmberg R. Health Care Professionals' Experiences and Views of eHealth in Pediatric Care: Qualitative Interview Study Applying a Theoretical Framework for Implementation. JMIR Pediatr Parent. 2023 Oct 18;6:e47663. doi: 10.2196/47663. PMID 37851500
DERIVEDHylen M, Nilsson S, Kristensson-Hallstrom I, Kristjansdottir G, Stenstrom P, Vilhjalmsson R. Access to health care perceived by parents caring for their child at home supported by eHealth-a directed approach introducing aperture. BMC Health Serv Res. 2022 Aug 8;22(1):1008. doi: 10.1186/s12913-022-08398-0. PMID 35941653
measure
Adverse events that occurs during the study period
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Any adverse events occurring during the study period will be recorded in free text format by the staff for all participants.
measure
The Clavien-Dindo Classification
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
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.
measure
Length of hospital stay
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Days
measure
Number of routine and acute visits
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Number of routine and acute visits
measure
Health economic variables: Family time
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Distribution of family time use
measure
Health economic variables: Family economy
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Family economy
measure
Health economic variables: Hopsital resources
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Use of hospital resources
measure
Health economic variables: Health care resources
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Use of other healthcare resources
measure
Health economic variables: Health care expenditures
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Healthcare expenditures by type of resource
measure
Health economic variables: Productivity
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Loss of production
measure
Health economic variables: Utility
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
Utility scores.
measure
EQ-5D-3L
timeFrame
After their participation in the study has ended, on average after 2-4 weeks.
description
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.