MIND Score for Prolonged Mechanical Ventilation (MIND)

Psychometric Validation of the Multi-INdependency Dimensions (MIND) Score for Patients Under Prolonged Mechanical Ventilation

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

Study Overview

• Status: Completed
• Conditions: Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • REMEO El Pilar
• Colombia
  • Bogota, Colombia
    • REMEO Bogota
  • Medellin, Colombia
    • REMEO Medellin
• Germany
  • Berlin, Germany
    • REMEO Centre
  • Berlin, Germany
    • REMEO Mahlow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the inclusion of biological markers on the overall performance of the MIND score	6 Months

Collaborators and Investigators

• Sponsor: Linde AG
• Investigators: Study Director: Joao C Winck, MD,PhD, Linde AG, Global Business Unit Healthcare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Estimate): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: Linde001