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CommunicationNCT03630003

Manually Operated Communication System

A study testing MOCS and Post-use interview in people with Communication and Ventilation Therapy; Complications, run by J. Matthias Walz at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to gather initial information about the testing of a novel manual communication system - which is currently called MOCS, for Manually Operated Communicated System - for mechanically ventilated Intensive Care Unit (ICU) subjects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MOCS and Post-use interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
28 Jun 2018to 15 Apr 2023
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are awake with a Glasgow Coma Scale score >10 (Motor 6, Verbal 0-1 [T], Eye opening 4) adult subjects at UMass Medical Center (Memorial and University ICUs) or at MGH (Bigelow 13, Lunder 6, Blake 7, Blake 12, or Ellison 4) are eligible for this study.
  • Both subjects who are able to speak and subjects who are unable to speak (due to intubation or tracheostomy) will be sought to be included in the study, although the focus will be on subjects who are unable to speak. (If additional feedback about the system from subjects who can speak would be helpful, this type of subject may be enrolled.)
  • Eligible subjects must have a history of being able to understand and communicate in written and spoken English, since the device software is in English.
  • May enroll both adults capable of consent and cognitively impaired adults, who will provide assent, if possible, and will have consent given by their legally authorized representative.

Who cannot join

  • non-adult individuals
  • prisoners

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UMass Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

The objective of this study is to gather initial information about the testing of a novel manual communication system - which is currently called MOCS, for Manually Operated Communicated System - for mechanically ventilated Intensive Care Unit (ICU) subjects. This study is not hypothesis based; the goal is to gather data about which interaction modes and teaching approaches of MOCS are most intuitive for subjects and caregivers.

Read the detailed description

Intensive Care Unit (ICU) admissions constitute a major part of hospital activity and resource allocation, and the number of patient days in ICUs and on mechanical ventilation is increasing. More than 5 million patients are admitted to an ICU annually in the United States, and approximately 55,000 critically ill patients are cared for each day. The most common cause for admission is respiratory insufficiency or failure; a study of data from 2005-2007 estimated that nearly 40 percent of ICU patients require mechanical ventilation.

Patients experience frequent emotional and psychiatric complications from ICU stays, including depression, anxiety, and post-traumatic stress disorder. One 2011 study found a prevalence of "clinically significant" depressive symptoms ranging from 17 percent to 43 percent among post-ICU patients. In 2013, it was reported that up to 50 percent of patients experience general anxiety symptoms one year after discharge, a rate much higher than in the broader US population.

Patients who temporarily lose the ability to speak report a high level of frustration. A study of 127 patients reported that, "two stressors, being intubated and not being able to talk, were significantly more stressful… than all the other stressors. The mean stressfulness score for [25] other stressors was between no distress and mild distress." Improving subject communication with ICU care team will likely require better technological interventions, and current best practice for assessing the optimal patient communication method is dependent on the evaluation of an experienced speech-language pathologist (SLP). Current approaches are insufficient for patient's needs, as one representative study described: "Patients rated 40% of the communication sessions with nurses as somewhat difficult to extremely difficult. Assistive communication strategies were uncommon, with little to no use of assistive communication materials (e.g., writing supplies, alphabet or word boards)." Designing an effective mode of communication for ICU patients unable to speak due to mechanical ventilation will likely improve patient's experiences and, potentially, long-term outcomes.

Some limited technologies exist to address these issues; however, they are not in widespread use due to a variety of reasons, including cost, lack of intuitiveness, and design that is not appropriate for the ICU setting. The investigators are designing a technological solution to assist ICU subjects in communicating with their caregivers, particularly nurses. The investigators are planning to do the initial testing of MOCS in the adult ICUs at the UMass Medical Center or at MGH.

The purpose of this stage of the project is to determine whether the device that has been designed in the previous study will be suitable for the needs of patients, families, and nurses. The investigators will be measuring duration of use, frequency and type of engagement, and mechanical stability.

Being tested
MOCS, Post-use interview
Keywords
ICU, critical care, alternative communication, augmentative communication
Medical subject headings
Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOCSDevice

    Also called Manually Operated Communication System

    The device consists of a tablet computer that can produce visual and auditory components designed to improve subject knowledge about setting and communication, mounted on a table or at the side of the bed in a place that is visible to the subject.

    The Arduino will be connected to switches/buttons and implemented in a 3D-printed platform.

  • Post-use interviewOther

    Also called Interview

    The Study team conducts an interview with participants to evaluate their experience with use of the MOCS device.

Study groups in NCT03630003
Study groupRoleWhat they receive
Use of MOCS with post-use interviewExperimentalThe patients in this arm will be asked to utilize the Manually Operated Communication System (MOCS) device and will then be asked to provide feedback on their experiences. Subjects will be asked to complete up to 3 sessions using the device. Each session is expected to last between 10 and 30 minutes. If the subject is interested in continuing, the session may last up to one hour. The study team will perform post-study interviews with each subject to ask about their experience with MOCS. The data collection forms will be filled out during the session by a member of the research team.
Receives: Device: MOCS; Other: Post-use interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ability to use make selections in software using handheld component

    Able to make selection by squeezing handheld component, activating tablet software response, 5 times within 5 minutes of use (including training)

    Measured: 1 hour

Secondary outcomes (3)
  1. Satisfaction assessed by modified SUS

    Patients, nurses, and family members will be asked to indicate their level of satisfaction with the communication software using a homegrown instrument to assess usability (modeled partly on the System Usability Scale, or SUS). Four questions are derived from the SUS; they assess likelihood of recommending, ease of use, ease of learning, and perceived ability to use the system for communication. Each of these questions are assessed on a 1-5 scale, with higher values representing a better outcome. The subscales of these questions are averaged to reach a total score.

    Measured: 30 days

  2. Duration of use

    The time spent using the system will be measured.

    Measured: 1 hour

  3. Level of engagement

    The number of each type of interaction with the system will be tabulated

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start28 Jun 2018
  3. Primary completion15 Apr 2023
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03630003
Sponsor's protocol ID
H00015391
Status last verified
Apr 2023
First submitted
3 Aug 2018
Last updated
1 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MOCS and Post-use interview in people with Communication and Ventilation Therapy; Complications, run by J. Matthias Walz at 2 sites in United States.

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 4 inclusion and 2 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Ability to use make selections in software using handheld component (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 May 2023; AzTrials last refreshed its copy on 2 Nov 2026.

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