Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, DisabilityMINDNCT02255058
MIND Score for Prolonged Mechanical Ventilation
An observational study of Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability, run by Linde AG at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability
- How many people
- 129 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Expected length of stay <48h, unable to achieve consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: 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
Read the 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.
- Conditions
- Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability
- Being tested
- No intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The study is a Prospective observational cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time
Measured: 6 Months
Secondary outcomes (1)
To assess the inclusion of biological markers on the overall performance of the MIND score
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linde AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joao C Winck, MD,PhD, Study director, Linde AG, Global Business Unit Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255058
- Sponsor's protocol ID
- Linde001
- Acronym
- MIND
- Status last verified
- Oct 2014
- First submitted
- 30 Sep 2014
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31221129
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Multi-INdependency Dimensions (MIND) Score for Patients Under Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02255058
- Acronym / sponsor ID
- MIND / Linde001
- Conditions
- Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Linde AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Expected length of stay <48h, unable to achieve consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThe study is a Prospective observational cohort study | Other | – |
Primary outcome
To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time
Time frame: 6 Months
1 secondary outcome
To assess the inclusion of biological markers on the overall performance of the MIND score
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Derived from this study: PubMed 31221129Winck 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joao C Winck, MD,PhD study director
Linde AG, Global Business Unit Healthcare
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability, run by Linde AG at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Colombia, Germany, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.