Psychometric Properties of a Mobile Application (IMITO)

Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)

Current methods to assess superficial size and area of pressure ulcers are either time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers).

A free smartphone application (for IOS or Android) has recently been developed to measures skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. The application computes the length, width and surface of the ulcer.

This technique has not yet been validated, although it has been used to measure various types of skin lesions.

The objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by comparison to the currently most frequently used techniques (Transparency Tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

imitoMeasure is a new smartphone application to measure wounds size. The present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients, providing consent for study, with complete or incomplete spinal cord injury, with pressure ulcers requiring hospital follow-up (lesion stade II to IV), followed at Centre Mutualiste Propara, rehabilitation centre, Montpellier, France

Description

Inclusion criteria:

• complete or incomplete spinal cord injury, all delays or aetiologies
• presence of one or more pressure ulcers stade II to IV
• adults

Exclusion criteria:

• refusal to participate
• local infection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure	Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure	immediately upon first assessment of patients

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure	Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure	immediately upon first assessment of patients
inter-rater and intra-rater validity of imitoMeasure	inter-rater and intra-rater validity of imitoMeasure	immediately upon first assessment of patients
Correlation of imitoMeasure of length and width of ulcers to ruler-based measures	Correlation of imitoMeasure of length and width of ulcers to ruler-based measures	immediately upon first assessment of patients

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Isabelle LAFFONT, University Hospital, Montpellier

Publications and helpful links

General Publications

• Do Khac A, Jourdan C, Fazilleau S, Palayer C, Laffont I, Dupeyron A, Verdun S, Gelis A. mHealth App for Pressure Ulcer Wound Assessment in Patients With Spinal Cord Injury: Clinical Validation Study. JMIR Mhealth Uhealth. 2021 Feb 23;9(2):e26443. doi: 10.2196/26443.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pressure ulcer; validity of measures
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: RECHMPL19_0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No