Psychometric Properties of a Mobile Application

NCT04402398 | Completed

• 1 other identifier: RECHMPL19_0280
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Pressure ulcer; validity of measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  immediately upon first assessment of patients

• Correlation of imitoMeasure of length and width of ulcers to ruler-based measures

  immediately upon first assessment of patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• refusal to participate
• local infection

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 33620327 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isabelle LAFFONT

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: May 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 20, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

FR (1)