Developmental DisabilityPEM-PlusNCT03820011
Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention
A study testing PEM+ in people with Developmental Disability and Early Intervention (Education), run by Mary A Khetani.
Trial summary
The goal of the proposed research is to achieve a major advance in promoting effective and efficient delivery of pediatric rehabilitation services for young children with developmental disabilities and delays. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability, Early Intervention (Education)
- What is being tested?
- PEM+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Aim 1 Inclusion Criteria:
- at least 18 years old
- reads, writes, and speaks English
- has access to broadband internet
- resides in the U.S
- has a child between 0 and 3 years old who is receiving services for developmental delay.
Aim 1 Exclusion Criteria:
- has a child over 3 years old
- does not have internet access
- has a child who is not receiving rehabilitation services for developmental delay
- does not reside in the U.S.
Aim 2 Inclusion Criteria:
- 18 years or older
- reads, writes, and speaks in English
- has a child aged 0-5 years old who was receiving rehabilitation services
- has broadband internet access
- denotes at least one area of desired change during participation assessment.
Aim 2 Exclusion Criteria:
- has a child over 5 years old
- does not have internet access
- has a child who is not receiving rehabilitation services for developmental delay
- does not reside in the U.S.
About this study
Official title: Feasibility Test of a Pediatric Web-Based Care Planning Guide
The goal of the proposed research is to achieve a major advance in promoting effective and efficient delivery of pediatric rehabilitation services for young children with developmental disabilities and delays. The investigative team will examine the usability, feasibility, acceptability, and preliminary effects of PEM+, an innovative web-based (mobile friendly) guide for care planning by parents of young children with developmental disabilities and delays. PEM+ is designed in partnership with parents and providers to support more collaborative and efficient clinical care planning with individual families who typically access pediatric occupational therapy services. Specifically, PEM+ enables parents to build on their baseline assessment of their child using the Young Children's Participation and Environment Measure (YC-PEM) to design specific solutions to their young child's participation-related problems. PEM+ affords parents the opportunity to do this in their own space and on their own schedule, as well as electronically share their proposed written solutions with their child's provider(s) and/or other important individuals in their young child's life.
Read the detailed description
Participation and Environment Measure Plus (PEM+) is a new electronic health application that facilitates family-centered and participation-focused intervention planning for young children receiving rehabilitation therapies. PEM+ design was informed by caregiver and provider input. It is a web-based intervention planning application that is designed for use by caregivers of young children receiving rehabilitation therapies. Caregivers who complete the Young Children's Participation and Environment Measure (YC-PEM), an electronic patient-reported outcome measure, evaluate their child's participation and then can click on a weblink to begin the PEM+ application, whereby they build on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many care plans for their child as needed), and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone). For the first aim of this study, caregivers completed one iteration of PEM+ to complete user tasks for the purpose of evaluating PEM+ usability. For the second aim of this study, caregivers were instructed to complete the PEM+ over a two-week (14 day) period. This time frame was selected by the research team as it mimics what would be provided in the routine care planning processes of early intervention and early childhood education.
- Being tested
- PEM+
- Keywords
- participation, environment, goal setting
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEM+Other
PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, relative to the number of activities in which change is desired based on the YC-PEM e-PRO, and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone).
| Study group | Role | What they receive |
|---|---|---|
| PEM-Plus Group | Experimental | For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface. Data on completion rate and time, as well as user satisfaction, were analyzed to guide PEM+ improvements. For Aim 2, we recruited 27 participants to enroll in a feasibility trial of PEM+. Caregivers who completed the YC-PEM e-PRO to evaluate their child's participation clicked on a weblink to begin PEM+, whereby they built on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a two-week (14 day) period because it mimics what would be provided in routine care. Receives: Other: PEM+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Retention Rates
As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.
Measured: Following completion of two-week trial
Median PEM+ Completion Time
As an indicator of PEM+ feasibility, we used web analytics to estimate the median time for completing the first and subsequent iterations within a two-week trial period
Measured: Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2)
Percentage of Caregivers Completing PEM+ Independently
As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created
Measured: Following completion of two-week trial
Median Number of PEM+ Care Plans Created
As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.
Measured: Following completion of two-week trial
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
As an indicator of PEM+ acceptability, the USE is a questionnaire that evaluates usefulness, ease of use, ease of learning, and satisfaction. Items are on a 7-point scale, from from [1] strongly disagree, to [7] strongly agree. There were multiple items for each domain, which were summed together and divided by the total number of items to generate a summary score for that domain. Higher scores indicate a better outcome.
Measured: Following completion of two-week trial
Caregiver Self-Efficacy to Promote Child's Participation in Activities
As an indicator of preliminary effects, we developed two items for this project to estimate caregiver self-efficacy in caring for their child, according to "what I will do next [to support child's participation]" and "how I think [about my child's participation]". Each item was rated on a 7-point scale, from [1] strongly disagree, to [7] strongly agree. Higher scores indicate a better outcome.
Measured: Following completion of two-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jul 2016
- Primary completion1 Feb 2018
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary A Khetani
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, McMaster University
- Responsible party
- Sponsor-investigator, Mary A Khetani, University of Illinois Chicago
- Investigators
- Mary A Khetani, ScD, Principal investigator, Board of Trustees at University of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820011
- Sponsor's protocol ID
- 2016-0600
- Acronym
- PEM-Plus
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2019
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Test of a Pediatric Web-Based Care Planning Guide
- ClinicalTrials.gov ID
- NCT03820011
- Acronym / sponsor ID
- PEM-Plus / 2016-0600
- Keywords
- participation, environment, goal setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mary A KhetaniUniversity, hospital or other
- Collaborators
- McGill University, McMaster University
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed research is to achieve a major advance in promoting effective and efficient delivery of pediatric rehabilitation services for young children with developmental disabilities and delays. The investigative team will examine the usability, feasibility, acceptability, and preliminary effects of PEM+, an innovative web-based (mobile friendly) guide for care planning by parents of young children with developmental disabilities and delays. PEM+ is designed in partnership with parents and providers to support more collaborative and efficient clinical care planning with individual families who typically access pediatric occupational therapy services. Specifically, PEM+ enables parents to build on their baseline assessment of their child using the Young Children's Participation and Environment Measure (YC-PEM) to design specific solutions to their young child's participation-related problems. PEM+ affords parents the opportunity to do this in their own space and on their own schedule, as well as electronically share their proposed written solutions with their child's provider(s) and/or other important individuals in their young child's life.
Detailed description
Participation and Environment Measure Plus (PEM+) is a new electronic health application that facilitates family-centered and participation-focused intervention planning for young children receiving rehabilitation therapies. PEM+ design was informed by caregiver and provider input. It is a web-based intervention planning application that is designed for use by caregivers of young children receiving rehabilitation therapies. Caregivers who complete the Young Children's Participation and Environment Measure (YC-PEM), an electronic patient-reported outcome measure, evaluate their child's participation and then can click on a weblink to begin the PEM+ application, whereby they build on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many care plans for their child as needed), and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone). For the first aim of this study, caregivers completed one iteration of PEM+ to complete user tasks for the purpose of evaluating PEM+ usability. For the second aim of this study, caregivers were instructed to complete the PEM+ over a two-week (14 day) period. This time frame was selected by the research team as it mimics what would be provided in the routine care planning processes of early intervention and early childhood education.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEM-Plus Group | Experimental | Other: PEM+For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface. Data on completion rate and time, as well as user satisfaction, were analyzed to guide PEM+ improvements. For Aim 2, we recruited 27 participants to enroll in a feasibility trial of PEM+. Caregivers who completed the YC-PEM e-PRO to evaluate their child's participation clicked on a weblink to begin PEM+, whereby they built on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a two-week (14 day) period because it mimics what would be provided in routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PEM+PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, relative to the number of activities in which change is desired based on the YC-PEM e-PRO, and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone). | Other | PEM-Plus Group |
Primary outcome
Mean Retention Rates
Time frame: Following completion of two-week trial
As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.
Median PEM+ Completion Time
Time frame: Following completion of PEM+ iteration (Aim 1) and two weeks (Aim 2)
As an indicator of PEM+ feasibility, we used web analytics to estimate the median time for completing the first and subsequent iterations within a two-week trial period
Percentage of Caregivers Completing PEM+ Independently
Time frame: Following completion of two-week trial
As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created
Median Number of PEM+ Care Plans Created
Time frame: Following completion of two-week trial
As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
Time frame: Following completion of two-week trial
As an indicator of PEM+ acceptability, the USE is a questionnaire that evaluates usefulness, ease of use, ease of learning, and satisfaction. Items are on a 7-point scale, from from [1] strongly disagree, to [7] strongly agree. There were multiple items for each domain, which were summed together and divided by the total number of items to generate a summary score for that domain. Higher scores indicate a better outcome.
Caregiver Self-Efficacy to Promote Child's Participation in Activities
Time frame: Following completion of two-week trial
As an indicator of preliminary effects, we developed two items for this project to estimate caregiver self-efficacy in caring for their child, according to "what I will do next [to support child's participation]" and "how I think [about my child's participation]". Each item was rated on a 7-point scale, from [1] strongly disagree, to [7] strongly agree. Higher scores indicate a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mary A Khetani, ScD principal investigator
Board of Trustees at University of Illinois
Questions about this trial
What is this clinical trial studying?
A study testing PEM+ in people with Developmental Disability and Early Intervention (Education), run by Mary A Khetani.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Retention Rates (time frame: Following completion of two-week trial). The study lists 6 primary outcomes in all. 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 18 Apr 2024.