Manually Operated Communication System

NCT03630003 | Completed FDA Device

• 1 other identifier: H00015391
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Communication; Ventilation Therapy; Complications

Keywords

ICU; critical care; alternative communication; augmentative communication

Outcome Measures

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)

  1 hour

Secondary Outcomes (3)

• Satisfaction assessed by modified SUS

  30 days

• Duration of use

  1 hour

• Level of engagement

  1 hour

Study Arms (1)

Use of MOCS with post-use interview

EXPERIMENTAL

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

MOCS DEVICE

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

Use of MOCS with post-use interview

Post-use interview OTHER

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

Also known as: Interview

Use of MOCS with post-use interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• non-adult individuals
• prisoners

Sponsors & Collaborators

• J. Matthias Walz: lead
• Brown University: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Communication

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• J. Matthias Walz, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Interim Chair, Dept of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 14, 2018
• Study Start: June 28, 2018
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)