search
Back to results

Smartphone App to Improve Functional Outcomes in Ankle Sprains (SPRAIN)

Primary Purpose

Ankle Sprains

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Smartphone app
Paper handout
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(i) Age 12-21 years (ii) Presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario, with a unilateral acute (<48 hours) ankle inversion injury.

(iii) Use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.

The diagnosis of an ankle inversion injury will be made on a clinical basis by the treating emergency physician after a fracture has been ruled out radiographically. We will include all grades of ankle injuries, including suspected Salter-Harris I of the distal tibia or fibula.

Exclusion Criteria:

  • Children unable to read or understand English above at least a grade 8 literacy level
  • Children who are not independently ambulatory (without the use of an assistive device)
  • Children with a developmental disability precluding the full comprehension of study-related procedures,
  • Children with multi-system or multi-limb injuries
  • Children with a concomitant lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury).

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smartphone app

Paper handout

Arm Description

The smartphone group will not be given paper-based discharge instructions in the ED. They will download onto their smartphone device an Intervention App that will allow recording of the above mentioned study outcomes and contains an interactive educational component encompassing the identical information outlined in the paper handout. The app will provide educational guidance towards recovery using a feedback algorithm that will recommend on a daily basis, the use of ice, elevation, range of motion exercises, and/or analgesics based on the participant's report of their pain using the FPS-R.

The paper handout group will be asked to read the paper-based discharge instructions in the ED, outlining pharmacological and non-pharmacological pain management and return to activity. They will download onto their smartphone device a Recording App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, pain using the Faces Pain Scale - Revised (FPS-R), and ASKp scores on days 3, 5, 7, 10, 12, and 14.

Outcomes

Primary Outcome Measures

Activities Scale for Kids performance version (ASKp)
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function

Secondary Outcome Measures

Activities Scale for Kids performance version (ASKp)
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Time to return to baseline ASKp score
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Pain using the Faces Pain Scale - Revised (FPS-R)
Self-report 6-item ordinal scale ranging from 0-5 with higher score indicating more pain
Use of non-pharmacological measures (ice, compression, other)
Frequency
Use of pharmacological analgesia (NSAIDs, acetaminophen)
Frequency

Full Information

First Posted
April 9, 2018
Last Updated
January 13, 2023
Sponsor
Lawson Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03564015
Brief Title
Smartphone App to Improve Functional Outcomes in Ankle Sprains
Acronym
SPRAIN
Official Title
Smartphone App to Improve Functional Outcomes in Children With Acute Ankle Inversion Injuries: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The intervention (guidance recovery app) was malfunctioning and not storing data for efficacy outcomes.
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, randomized, open-label, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone app
Arm Type
Experimental
Arm Description
The smartphone group will not be given paper-based discharge instructions in the ED. They will download onto their smartphone device an Intervention App that will allow recording of the above mentioned study outcomes and contains an interactive educational component encompassing the identical information outlined in the paper handout. The app will provide educational guidance towards recovery using a feedback algorithm that will recommend on a daily basis, the use of ice, elevation, range of motion exercises, and/or analgesics based on the participant's report of their pain using the FPS-R.
Arm Title
Paper handout
Arm Type
Active Comparator
Arm Description
The paper handout group will be asked to read the paper-based discharge instructions in the ED, outlining pharmacological and non-pharmacological pain management and return to activity. They will download onto their smartphone device a Recording App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, pain using the Faces Pain Scale - Revised (FPS-R), and ASKp scores on days 3, 5, 7, 10, 12, and 14.
Intervention Type
Other
Intervention Name(s)
Smartphone app
Intervention Description
Apple or Android app to provide education to guide functional recovery and allow recording of pain, management, and functional outcome using the Activities Scale for Kids performance version (ASKp) at home
Intervention Type
Other
Intervention Name(s)
Paper handout
Intervention Description
Paper handout to guide functional recovery. Also includes a version of the smartphone app described above that only allows recording of pain, functional outcome, and management at home.
Primary Outcome Measure Information:
Title
Activities Scale for Kids performance version (ASKp)
Description
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Time Frame
Day 14 +/- 1 day post-discharge
Secondary Outcome Measure Information:
Title
Activities Scale for Kids performance version (ASKp)
Description
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Time Frame
Day 3, 5, 7, 10, and 12 +/- 1 day post-discharge
Title
Time to return to baseline ASKp score
Description
30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function
Time Frame
Days 1-14 post discharge
Title
Pain using the Faces Pain Scale - Revised (FPS-R)
Description
Self-report 6-item ordinal scale ranging from 0-5 with higher score indicating more pain
Time Frame
Days 1-14 post discharge
Title
Use of non-pharmacological measures (ice, compression, other)
Description
Frequency
Time Frame
Days 1-14 post discharge
Title
Use of pharmacological analgesia (NSAIDs, acetaminophen)
Description
Frequency
Time Frame
Days 1-14 post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (i) Age 12-21 years (ii) Presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario, with a unilateral acute (<48 hours) ankle inversion injury. (iii) Use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App. The diagnosis of an ankle inversion injury will be made on a clinical basis by the treating emergency physician after a fracture has been ruled out radiographically. We will include all grades of ankle injuries, including suspected Salter-Harris I of the distal tibia or fibula. Exclusion Criteria: Children unable to read or understand English above at least a grade 8 literacy level Children who are not independently ambulatory (without the use of an assistive device) Children with a developmental disability precluding the full comprehension of study-related procedures, Children with multi-system or multi-limb injuries Children with a concomitant lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Knechtel, BA
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Smartphone App to Improve Functional Outcomes in Ankle Sprains

We'll reach out to this number within 24 hrs