Clinical trial NCT02255058: MIND Score for Prolonged Mechanical Ventilation
Official title: Psychometric Validation of the Multi-INdependency Dimensions (MIND) Score for Patients Under Prolonged Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability
Lead sponsor: Linde AG
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung injury, COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative, Cardiovascular Disorders, Trauma, Other.

Brief summary: It was decided to develop a comprehensive disability score specifically designed for patients receiving prolonged mechanical ventilation (PMV); the collection of information included in the score should not impose any further intervention beyond what is routinely performed. So a new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included 3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each question was adapted to have a 5 item Likert scale.

The primary objective of the study will be to evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time. The secondary objective will be to assess the inclusion of biological markers on the overall performance of the MIND score

Detailed description: Following recruitment all participants will be assessed by a medical doctor or respiratory therapist (trained on the study) who will fill out the MIND questionnaire on admission and make sure the other scales/questionnaires are also completed. On the same day of the collection of MIND, MRC score for quadriceps and biceps strength, Sequential Organ Failure Assessment (SOFA) score, Glasgow coma scale, Hospital Anxiety-depression scale (HADS), EuroQol-5D, Gussago Dependence Nursing Scale (GNS) will be also gathered. After 1 day and 30 days the MIND questionnaire will be also evaluated. Index of ADL-(Katz index) will be evaluated on discharge as well as weaning rate and survival.

Sample Size Determination

Based on the method of Rouquette A et al (1) we estimated a sample size of 200 patients to allow for the Rasch modelling to be applied.

Statistical analysis

Assessment of construct validity:

Confirmation of the structure (e.g. multitrait analysis), clinical validity (comparison of disability score according to external clinical criteria)

Assessment of reliability:

Internal consistency reliability (using Cronbach's alpha), test-retest reliability (using intraclass correlations)

Assessment of sensitivity to change over time:

Comparison of change in disability score according to change in external clinical criteria Guidance for interpretation of disability score: Estimation of thresholds for patients' classification

1-Rouquette A, Falissard B Sample size requirements for the internal validation of psychiatric scales Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352. Epub 2011 Oct 24.

Eligibility criteria: Inclusion Criteria:

* Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung injury, COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative, Cardiovascular Disorders, Trauma, Other.

Exclusion Criteria:

* Expected length of stay \<48h, unable to achieve consent

Primary outcomes:
measure: To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time
timeFrame: 6 Months
Secondary outcomes:
measure: To assess the inclusion of biological markers on the overall performance of the MIND score
timeFrame: 6 Months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: REMEO El Pilar
city: Bogota
country: Colombia
facility: REMEO Bogota
city: Medellin
country: Colombia
facility: REMEO Medellin
city: Berlin
country: Germany
facility: REMEO Centre
city: Berlin
country: Germany
facility: REMEO Mahlow
Study officials:
affiliation: Linde AG, Global Business Unit Healthcare
name: Joao C Winck, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Winck JC, Gilet H, Kalin P, Murcia J, Plano F, Regnault A, Dreher M, Vitacca M, Ambrosino N. Validation of the Multi-INdependence Dimensions (MIND) questionnaire for prolonged mechanically ventilated subjects. BMC Pulm Med. 2019 Jun 20;19(1):109. doi: 10.1186/s12890-019-0870-2.