Motor DisordersWeCareNCT04254302
Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old
A study testing WECARE web platform in people with Motor Disorders, run by Université de Sherbrooke at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Motor Disorders
- What is being tested?
- WECARE web platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Motor Disorders
- Being tested
- WECARE web platform
- Keywords
- Tele-intervention, Motor delay, Child, Parental support
- Medical subject headings
- Motor Disorders, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WECARE web platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized into the control arm will receive usual care as per the service delivery models and pathways planned in their region. As a pragmatic trial, no attempt will be made to standardize practices which may vary across professionals. Usual practices may be categorised as either reference to online websites deemed appropriate by their healthcare professional, general recommendations, referral for services, or none of the above. |
| Experimental | Experimental | WECARE intervention include: 1) 30-minute appointments with an occupational therapist or a physiotherapist, as part of a multidisciplinary team, to problem-solve the child's motor performance issues, provide recommendations to stimulate the child's motor development, and intervene online directly with the child, if needed; offered bimonthly during the first three months, then on a patient-identified needs-basis. 2) A chat function where participants can privately contact the therapist; flexible access as per participant needs. 3) A forum open to all intervention group participants where they can communicate with each other or with the therapist, who will also act as a forum moderator; flexible access as per participant needs. 4) Access to static online information via relevant websites and resources on child development; flexible access based on participant needs. Receives: Other: WECARE web platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
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".
Measured: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
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.
Measured: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
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).
Measured: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
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).
Measured: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Feb 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The family will be the unit of randomization. A web-based randomization service will allocate participants to either usual care or the WECARE intervention (1:1). To ensure equal distribution of participants between arms, permutated blocks of variable (2:4:6) size will be generated. No stratification or minimization strategies will be used. Participants will be invited to set their motor-performance goals before allocation to avoid the influence of the allocation group on goals selection.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Chantal Camden, Université de Sherbrooke
- Investigators
- Chantal Camden, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254302
- Sponsor's protocol ID
- 2020-3429
- Acronym
- WeCare
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04254302
- Acronym / sponsor ID
- WeCare / 2020-3429
- Conditions
- Motor Disorders
- Keywords
- Tele-intervention, Motor delay, Child, Parental support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The family will be the unit of randomization. A web-based randomization service will allocate participants to either usual care or the WECARE intervention (1:1). To ensure equal distribution of participants between arms, permutated blocks of variable (2:4:6) size will be generated. No stratification or minimization strategies will be used. Participants will be invited to set their motor-performance goals before allocation to avoid the influence of the allocation group on goals selection.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized into the control arm will receive usual care as per the service delivery models and pathways planned in their region. As a pragmatic trial, no attempt will be made to standardize practices which may vary across professionals. Usual practices may be categorised as either reference to online websites deemed appropriate by their healthcare professional, general recommendations, referral for services, or none of the above. |
| Experimental | Experimental | Other: WECARE web platformWECARE intervention include: 1) 30-minute appointments with an occupational therapist or a physiotherapist, as part of a multidisciplinary team, to problem-solve the child's motor performance issues, provide recommendations to stimulate the child's motor development, and intervene online directly with the child, if needed; offered bimonthly during the first three months, then on a patient-identified needs-basis. 2) A chat function where participants can privately contact the therapist; flexible access as per participant needs. 3) A forum open to all intervention group participants where they can communicate with each other or with the therapist, who will also act as a forum moderator; flexible access as per participant needs. 4) Access to static online information via relevant websites and resources on child development; flexible access based on participant needs. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WECARE web platformThe 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. | Other | Experimental |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 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)).
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.
5 secondary outcomes
Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT)
Time frame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Parental Knowledge and Skills Questionnaire (PKSQ)
Time frame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Parental Stress Scale (PSS)
Time frame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Six Dimension Short-Form Health Survey (SF-6D)
Time frame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Health-Related Quality of Life Utility Measure for Pre-School Children (HuPS)
Time frame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Camden, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WECARE web platform in people with Motor Disorders, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: 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)).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.