CommunicationNCT04105751
Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients
A study testing Novel Communication System in people with Communication and Ventilation Therapy; Complications, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The objective of this study is to gather initial information about the testing of a novel manual communication system for mechanically ventilated Intensive Care Unit (ICU) subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Ventilation Therapy; Complications
- What is being tested?
- Novel Communication System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2016to 20 Aug 2019
- 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
- PHASE 1
- Subjects who are awake, alert, and without clear evidence of delirium (GCS>13) adult subjects in the Memorial and University ICUs 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.
- Eligible subjects must have a history of being able to understand and communicate in written and spoken English or Spanish.
- Any subject who is capable of consent but cannot speak will provide consent by signing the consent form if possible, with a witness, who is not a member of the research team, present who will sign the appropriate section of the consent form.
- PHASE 2
Show all 10Show fewer
- Subjects who are awake with a GCS>10 (Motor 6, Verbal 1, Eye opening 3) adult subjects in the Memorial and University ICUs 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.
- Eligible subjects must have a history of being able to understand and communicate in written and spoken English or Spanish.
- 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
- PHASE 1/PHASE 2
- Spanish-speaking individuals may be included in the study under the following conditions:
- Spanish interpreter is available in person or by phone for the consent process.
- The consent process is followed as outlined in question 30-31, depending on whether subject is able to speak or not at this time.
- No other non-English-speaking subjects will be included in the study.
- The following vulnerable populations will not be included in the study:
- Pregnant women, non-adult individuals, prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
The objective of this study is to gather initial information about the testing of a novel manual communication system for mechanically ventilated Intensive Care Unit (ICU) subjects. This phase of the study is not hypotheses based; the goal is to gather data about which potential form factors and interaction modes of the proposed communication system 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 this device in the adult ICUs at the University of Massachusetts Memorial Medical Center at both the University Campus and Memorial Campus.
The purpose of this stage of the project is to test the current device and determine whether the physical factors and interaction modes that have been designed up to this point will be appropriate for the needs and desires of ICU subjects while communicating.
- Conditions
- Communication, Ventilation Therapy; Complications
- Being tested
- Novel Communication System
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Communication SystemDevice
Small hand held device that aids in answering questions. Used in conjunction with a tablet computer.
| Study group | Role | What they receive |
|---|---|---|
| Use of Device with post-use interview/questionnaire | Experimental | All patients will be asked to utilize device and will then be asked to provide feedback on their experiences. This may be done by interview or a questionnaire. There could be up to three sessions using the device. Each session is expected to last between 10 and 30 minutes. If the subject is interested in continuing, session could last up to one hour. Receives: Device: Novel Communication System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of user to make one or more selections in the software
Whether the user is able to make one or more selections in the software will be evaluated.
Measured: 1 hour
Secondary outcomes (1)
Duration of use
The time spent using the system within a one-hour time frame will be measured.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start6 Sep 2016
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, J. Matthias Walz, University of Massachusetts, Worcester
- Investigators
- J. Matthias Walz, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105751
- Sponsor's protocol ID
- H00010101
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2019
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT04105751
- Acronym / sponsor ID
- H00010101
- Conditions
- Communication, Ventilation Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 26 Sep 2019 (actual)
- 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.
The objective of this study is to gather initial information about the testing of a novel manual communication system for mechanically ventilated Intensive Care Unit (ICU) subjects. This phase of the study is not hypotheses based; the goal is to gather data about which potential form factors and interaction modes of the proposed communication system are most intuitive for subjects and caregivers.
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 this device in the adult ICUs at the University of Massachusetts Memorial Medical Center at both the University Campus and Memorial Campus.
The purpose of this stage of the project is to test the current device and determine whether the physical factors and interaction modes that have been designed up to this point will be appropriate for the needs and desires of ICU subjects while communicating.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Device with post-use interview/questionnaire | Experimental | Device: Novel Communication SystemAll patients will be asked to utilize device and will then be asked to provide feedback on their experiences. This may be done by interview or a questionnaire. There could be up to three sessions using the device. Each session is expected to last between 10 and 30 minutes. If the subject is interested in continuing, session could last up to one hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- PHASE 1
- Subjects who are awake, alert, and without clear evidence of delirium (GCS>13) adult subjects in the Memorial and University ICUs 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.
- Eligible subjects must have a history of being able to understand and communicate in written and spoken English or Spanish.
- Any subject who is capable of consent but cannot speak will provide consent by signing the consent form if possible, with a witness, who is not a member of the research team, present who will sign the appropriate section of the consent form.
Key exclusion criteria (7 listed)
- PHASE 1/PHASE 2
- Spanish-speaking individuals may be included in the study under the following conditions:
- No other non-English-speaking subjects will be included in the study.
- The following vulnerable populations will not be included in the study:
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 |
|---|---|---|
| Novel Communication SystemSmall hand held device that aids in answering questions. Used in conjunction with a tablet computer. | Device | Use of Device with post-use interview/questionnaire |
Primary outcome
Ability of user to make one or more selections in the software
Time frame: 1 hour
Whether the user is able to make one or more selections in the software will be evaluated.
1 secondary outcome
Duration of use
Time frame: 1 hour
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 1 May 2023.
- Individual participant dataSharing planned: No
Related trials for Communication
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Recruiting
Keep Social Randomized Controlled Trial for Young Adults With Cancer
Cancer
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
Not yet recruiting
Culturally-Tailored AI Chatbot Simulation for Therapeutic Communication and Empathy in Psychiatric Nursing Students
Therapeutic Communication
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.
J. Matthias Walz, MD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Communication System in people with Communication and Ventilation Therapy; Complications, run by University of Massachusetts, Worcester at 1 site 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 10 inclusion and 7 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 1 site 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 of user to make one or more selections in the software (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.