Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old

Motor Disorders Clinical Trial

— WeCare  

Official title:

WECARE - Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old: A Patient-centred, Mixed-method Innovative Pragmatic Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254302
• Other study ID #: 2020-3429
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Many children (about 1 child out of 20) have motor delays that are sometimes seen as "minor" and are not immediately explained by a specific diagnosis. These children are often underserved by existing health and rehabilitation services even though they are at risk of developing important negative outcomes in the long run. The most recent scientific evidence indicates that motor delays can be effectively addressed via early interventions supporting families and stimulating the child's development. Some researchers have proposed that such interventions could be efficiently and conveniently delivered online but no patient-centred, interactive online intervention has been formally trialed in Canada for children with motor delay and their families.

Objectives: The goal of this study is to determine whether an online intervention can support families of children with motor delay. This study will determine whether the online intervention can improve the child's motor skills and parental self-efficacy, decrease parental stress, as well as increase the quality of life of both the parent and child.

Description: The investigators will recruit 118 families of children with motor delay, 3 to 8 years of age, who are not yet receiving public rehabilitation services. These children will have been identified as at-risk of motor difficulties by their parents who will have completed a self-reported screening test for motor difficulties. Families will be randomly assigned to one of two groups: 1) control group (usual care) or 2) intervention group (access to the WECARE web platform, including one-on-one virtual meetings with health professionals, group and private discussions, verified resources). This study, conducted in Quebec, will be led by researchers, telerehabilitation experts, decision makers and patient advocates.

Relevance: This study will evaluate an innovative, convenient and accessible intervention providing assistance for an important yet underserved population of children and their families.

Description:

Detailed objectives:

The overarching goal of this patient-centred, mixed-methods, randomized, innovative pragmatic trial is to evaluate the effectiveness of the WECARE intervention for children aged 3-8 years with motor difficulties living in Quebec. The primary objective is to evaluate, in comparison to usual care management, the effectiveness of the WECARE program for improving the child's performance on parent-identified motor functioning targets. Secondary objective is to evaluate the effect of the intervention on children's functioning, parental self-efficacy, parental stress, as well as the quality of life of both the parent and child.

Detailed design: A patient-centred innovative pragmatic randomized controlled trial documenting real-world effectiveness of the WECARE intervention, offered to families of children with motor difficulties living in Quebec and receiving no public rehabilitation services. A primary respondent (i.e., parent or legal guardian) will be identified but the whole family will have access to the WECARE intervention.

This trial was designed according to the latest guidelines on pragmatic trials, using the gold-standard CONSORT guidelines, and the TElehealth in CHronic Disease (TECH) conceptual framework.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• Parent or legal guardian of a child aged 3-8 years old at risk of motor difficulties, as confirmed via the DCD-Questionnaire or Little DCD-Q

• Have at least one motor-related COPM objective at T0

• Live in Quebec.

Exclusion Criteria:

• Children receiving public rehabilitation services for their motor difficulties at time of enrolment (i.e. receiving either physiotherapy or occupational therapy services)

• Families whose parents could not provide a single motor performance related goal to inform the intervention.

Related Conditions & MeSH terms

• Motor Disorders

Intervention

Other:
• WECARE web platform
The WECARE intervention allows families of children with motor difficulties to access rehabilitation therapists. The primary therapist will be an occupational therapist or a physiotherapist who will have one day a week to deliver the intervention. The therapist will act as case manager to connect families with community-based services available in their region and work, according to a transdisciplinary model, with an interdisciplinary team on a needs-based basis. Patient engagement with the therapists and in the WECARE intervention will be ensured by the collaborative coaching approach used by therapists to attain meaningful motor outcomes, as selected by the primary respondent.

Locations

Country	Name	City	State
Canada	Centre de recherche du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure (COPM)	The COPM uses a structured interview to identify intervention goals. Ten-point numerical rating scales are then used to identify importance, actual performance and satisfaction with performance for each selected goal. Higher scores indicate higher importance, better performance and higher satisfaction with the child's performance. An increase of more than 2 points on the 10-point numerical rating scale is considered as a meaningful clinical difference and will be used as an indication of the attainment of the child's motor performance goal. The COPM does not require any physical or hands-on materials, which is consistent with an online trial.	Structured interview and numerical rating scales : before intervention. Numerical rating scales only : every 3 months for 12 months (i.e 3 months, 6 months, 9 months and one year after the beggining of the intervention)).
Secondary	Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT)	The PEDI-CAT is a parent-reported adaptative questionnaire for parents of children between the ages of 0 and 20 years old. Each question is selected by the computer algorithm based on the child's socio-demographic data and answers to previous questions. A maximum of 15 questions are asked for each domain. The number of items needed to establish the child's score may vary according to the stopping rules of the algorithm. For each question, parents indicate their child's ability to participate in a presented activity (e.g. Putting on socks) on a 4-points scale ranging from "Unable = Can't do, doesn't know how or is too young" to "Easy = Does with no help, extra time, or effort, or child's skills are past this level". The score for each subscale is expressed in T-scores. The Daily activities and Mobility subscales of the Short Form PEDI-CAT will be used in this project.	Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Secondary	Parental Knowledge and Skills Questionnaire (PKSQ)	The PKSQ has been validated to evaluate the self-efficacy of parents of children with Developmental coordination disorder (DCD) aged 0-18 years-old. An adapted version of the PKSQ will be used to remove the focus from DCD and ensure its relevance for all motor difficulties. The adapted PKSQ includes two out of the three constructs of the original version of the PKSQ. The adapted version includes 14 questions about parental understanding of motor difficulties and their perception of their capacity to manage their child's motor difficulties. Questions are scored by the parent on a 7-point Likert scale ranging from "Not at all" to "To a very great extent".	Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Secondary	Parental Stress Scale (PSS)	Parental stress will be measured with the Parental stress scale (PSS). The PSS includes 18 questions about parental feelings and experience of parenting. Each statement is scored on a 5-point Likert scale (1=Strongly agree to 5=Strongly disagree). Higher scores indicate lower parental stress.	Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Secondary	Six Dimension Short-Form Health Survey (SF-6D)	Changes in the parent's quality of life will be measured with the Six Dimension Short-Form Health Survey (SF-6D). The SF-6D is a tool measuring health utilities in adults. It includes items on physical and social functioning, role limitations, pain, mental health and vitality. The total score is reported on a scale ranging from 0,29 to 1, where 1 represents a perfect health (i.e. a greater score means a better health).	Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Secondary	Health-Related Quality of Life Utility Measure for Pre-School Children (HuPS)	Changes in children's quality of life will be measured with the Health-Related Quality of Life Utility Measure for Pre-School Children (HuPS) tool. The HuPS includes 12 questions about the child's abilities rated on a 3- to 5-point scale (e.g.: seeing, speaking, using hand and fingers, selfcare). Changes in the parent's quality of life will be measured with the Six Dimension Short-Form Health Survey (SF-6D). The SF-6D is a tool measuring health utilities in adults. It includes items on physical and social functioning, role limitations, pain, mental health and vitality. The total score is reported on a scale ranging from 0 to 1, where 1 represents a perfect health (i.e. a greater score means a better health).	Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]