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CompletedNCT03630003Updated May 1, 2023

Manually Operated Communication System

An interventional study of MOCS and Post-use interview in Communication and Ventilation Therapy; Complications, sponsored by J. Matthias Walz. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by J. Matthias Walz · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Apr 2023, 3 years 6 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Communication
  • Ventilation Therapy; Complications

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Keywords

  • ICU
  • critical care
  • alternative communication
  • augmentative communication
03

In context

Communication

719 studies on the registry are indexed under Communication; 159 are open to participants now.

This study's enrollment of 20 is below the median of 144 across 571 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

J. Matthias Walz is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. 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.)
  3. 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.
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. non-adult individuals
  2. prisoners
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Use of MOCS with post-use interview

    The 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.

    Device: MOCS · Other: Post-use interview

Interventions

  • DeviceMOCS

    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.

    Also known as: Manually Operated Communication System

  • OtherPost-use interview

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

    Also known as: Interview

06

What researchers measure

Primary outcomes

  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)

    Time frame: 1 hour

Secondary outcomes

  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.

    Time frame: 30 days

  2. Duration of use

    The time spent using the system will be measured.

    Time frame: 1 hour

  3. Level of engagement

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

    Time frame: 1 hour

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • UMass Medical School
    Worcester, Massachusetts 01655, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03630003
Lead sponsor
J. Matthias Walz
Collaborators
Brown University
Responsible party
J. Matthias Walz (Professor and Interim Chair, Dept of Anesthesiology and Perioperative Medicine, University of Massachusetts, Worcester) — Sponsor-investigator
First posted
Aug 14, 2018
Start date
Jun 28, 2018
Primary completion
Apr 15, 2023
Completion
Apr 15, 2023
Last update
May 1, 2023

Study contacts

J. Matthias Walz, MD
principal investigator · UMass Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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