Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03564015 |
| Other study ID # |
111817 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
December 20, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Lawson Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Ankle sprains are the most common musculoskeletal complaint of children presenting to the
emergency department (ED). Healing can often be protracted, leading to prolonged pain, missed
school and work, and delayed return to a normal activity level. Smartphone apps have been
shown to be associated with greater caregiver knowledge and improved outcomes in a number of
conditions but have not been explored in ankle sprains. The investigators would like to know
if using a smartphone app for children with ankle inversion injuries leads to improved
functional outcomes such as pain, mobility, and return to activity. The investigators will be
comparing a smartphone app that provides education and daily management reminders to a paper
handout to see if the former leads to improved functional recovery.
Description:
Comprehensive discharge instructions are an integral part of care children discharged from
the emergency department (ED). Unfortunately, providing consistent and thorough discharge
instructions is highly limited by the workflow constraints of a busy ED. Currently, paper
instructions are the standard for providing ED discharge information. Yet, there remains a
great deal of variety in delivery of discharge instructions (1) and there is evidence that
patients often do not fully comprehend (2, 3), recall (4), nor comply (5) with discharge
instructions. Consequently, caregivers often commit errors related to knowledge and execution
of ED discharge instructions (6). The use of a smartphone app following discharge from the ED
offers a potential means to improve adherence to discharge instructions through consistent
information, simplification of content, and reminders (2). Acute ankle sprains are one of the
most common complaints presenting to primary care offices and EDs (7). In Canada and the
United States, there are more than 2 million ED visits annually due to ankle trauma in
children; 85% due to forced inversion (8). Adolescents and young adults have the highest
incidence of ankle sprain (7.2 per 1,000 person-years). Although ankle sprains are often
perceived as minor injuries, they can have a highly variable prognosis, with up to 64% of
patients failing to achieve full recovery (9). Current guidelines are limited in determining
prognostic factors associated with functional recovery (9). The resulting 'one-size fits all'
approach (controlling acute inflammatory symptoms (9), using cryotherapy and
anti-inflammatory medications, and early mobilization (7)) fails to consider the grade of
injury, baseline level of functioning, and individual pain tolerance of the child.
Educational guidance individualized to pain beyond the ED may improve functional outcomes. As
of 2015, 82% of people age 18-49 years owned an app-enabled smartphone, and over half (58%)
download health related smartphone apps (10). In adult medicine, many health-related
smartphone apps have been shown to be associated with greater caregiver knowledge and
improved outcomes in allergic rhinitis (10), post-operative monitoring (11), and
musculoskeletal conditions (12). In children and adolescents, several studies have explored
smartphone apps for asthma (13) and diabetes (14, 15). To date however, no smartphone apps
have been developed for acute musculoskeletal injury management in children.
