Status:
RECRUITING
The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Boston Children's Hospital
Conditions:
Cerebral Palsy Infantile
Disabilities Multiple
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
The goal of this pilot randomized controlled trial is to test the feasibility of running a full scale randomized controlled trial that compares the effect of the PQ-ResPOND intervention versus usual c...
Detailed Description
Background: In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI). Over 60% of these children endure uncontrolled ...
Eligibility Criteria
Inclusion
- Parent-child dyads will be included based on the following criteria:
- Child participants will be selected from the base population of patients who are:
- ≥ 1 year old,
- receiving routine (ongoing) care at Boston Children's Hospital, AND
- followed by the Neurology, Cerebral Palsy or Complex Care services.
- All patients from the base population will be screened to include any patient who:
- has severe neurological impairment, defined as:
- a Central Nervous System disorder resulting in motor and cognitive impairment and an inability to communicate either verbally or through sign language, AND
- has complete caregiver dependency for activities of daily living AND
- date of diagnosis of SNI is ≥ 4 months prior to the date of screening
Exclusion
- Parent-child dyads will be excluded if any of the following apply:
- the child,
- is already followed by the palliative care team, OR
- is not expected to survive at least 2 months after enrollment; OR
- does not have "moderate to severe recurrent pain", as measured through the baseline Child Pain Survey (PPP). Specifically, we will exclude participants whose:
- "Good days" AND "Difficult days" PPP scores are \<14, AND
- "Most troublesome pain" PPP score is \<30, AND
- Number of "difficult days" are \<8 in past month, AND
- Number of days with "most troublesome pain" are \<4 in past month; OR • both parents,
- do not have legal guardianship, OR
- are unable to read, write, and speak English OR Spanish
- are unable to understand and complete surveys.
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06075797
Start Date
May 8 2024
End Date
July 31 2025
Last Update
July 30 2025
Active Locations (4)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Deakin University
Burwood, Victoria, Australia, 3125