Clinical trial NCT04402398: Psychometric Properties of a Mobile Application
Official title: Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: Pressure ulcer
validity of measures
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
timeFrame: immediately upon first assessment of patients
Secondary outcomes:
measure: Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure
timeFrame: immediately upon first assessment of patients
measure: inter-rater and intra-rater validity of imitoMeasure
timeFrame: immediately upon first assessment of patients
measure: Correlation of imitoMeasure of length and width of ulcers to ruler-based measures
timeFrame: immediately upon first assessment of patients
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Isabelle LAFFONT
role: STUDY_DIRECTOR
References:
citation: 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.