Vidatalk Communication Application: Usability, Acceptability and Efficacy Study

NCT02921776 | Completed Results DMC FDA Device

• 1 other identifier: 2016H0006
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive patient communication solution for communication-impaired patients in the intensive care unit that may help decrease days in delirium, decrease anxiety levels, and reduce sedation exposure which are proximal outcomes known to be associated with decreased mechanical ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare cost. The primary goal of this Phase II STTR proposal is to further define user requirements and product specifications and develop a prototype of VidaTalk, a patient-centric, touch pad communication software, to provide mechanically ventilated (MV) patients an evidence-based solution for effectively communicating their needs to care providers and family. A secondary goal is to test the impact of the VidaTalk on clinical outcomes. This study will use mixed methods including observations and interaction with hospitalized patients as they use the VidaTalk tool, surveys and medical record data extraction, product evaluation and brief interview, satisfaction surveys with family members of ICU patients, and focus groups with Registered Nurses. Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and customizable messages, compatibility with tablet devices, picture symbols, and integration with mobile communication devices. Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical setting. Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3 hypothesis: MV patients using VidaTalk will demonstrate significant reductions in patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control (i.e., tablets with health education application). Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale. Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers.

Conditions

Nonverbal Communication; Critical Illness

Keywords

Vidatalk; App; Augmentative and Alternative Communication; iPad; Android; Mechanical ventilation; Patient Communication; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale

  Aim 3 - Mean item score of daily by patient self report using a single item Likert-type scale from the Ease of Communication Scale (ECS) where scores range from 0 "not hard at all" to 4 "extremely hard"

  Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Secondary Outcomes (20)

• Mean Patient Reported Anxiety Score Using Visual Analogue Scale

  Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

• Mean Patient Frustration With Communication

  Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

• Mean Daily Sedation Exposure

  Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU daily in ICU

• Ease of Communication at Extubation /ICU Discharge

  measured at Extubation /ICU Discharge

• Percentage of Patients Scoring in the "Calm" Range During Study Days on Richmond Agitation Sedation Score

  Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Study Arms (5)

Aim 1- VidaTalk post-extubation

EXPERIMENTAL

Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 and Group 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUWMC (Ohio State University Wexner Medical Center), including discharged patients. Group 1 will use an initial android prototype of VidaTalk tablet application to be assessed for functionality (ergonomics, ease of use, ease of learning, simplicity, effectiveness and user interface) and usability on customizable communication, picture symbols, and integration with mobile communication devices. Group 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Group 1 sessions.

Other: Aim 1 - VidaTalk - post-extubation

Aim 2 - VidaTalk intubated

EXPERIMENTAL

Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app

Other: Aim 2 - VidaTalk - intubated

Aim 3 - VidaTalk tablet app

EXPERIMENTAL

Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application.

Device: Aim 3 - VidaTalk tablet app

Aim 3 - attention-control

OTHER

35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet.

Other: Aim 3 - attention-control with non-VidaTalk tablet

Aim 5-VidaTalk Efficacy in Family caregivers

NO INTERVENTION

Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured.

Interventions

Aim 1 - VidaTalk - post-extubation OTHER

Observation of task completion will be made while patients complete a series of messages using the VidaTalk app: * Tell me you are tired * Tell me you are having pain * Rate this pain * Tell me there is pain in your back * Tell me your pain is sharp * Ask to see the doctor * Write your favorite color by drawing with your finger * Type "How are you?" Patients will also complete a 1-item difficulty rating and a 3-item After-Scenario Questionnaire (ASQ) after each task. Patients will also be asked to (a) comment on the customization of the app and make suggestions; (b) rate the extent to which they would use the device if they were an ICU patient and unable to speak. Group 1 only: Patients will be asked about their preferences for customizing the VidaTalk app.

Aim 1- VidaTalk post-extubation

Aim 2 - VidaTalk - intubated OTHER

Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS).

Aim 2 - VidaTalk intubated

Aim 3 - VidaTalk tablet app DEVICE

Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.

Aim 3 - VidaTalk tablet app

Aim 3 - attention-control with non-VidaTalk tablet OTHER

Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet.

Aim 3 - attention-control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Able to communicate in English
• Awake alert, responding appropriately to commands.
• Normal (aided or unaided) hearing and vision
• Able to control head, arm and hand movements
• Physiologically stable and in no acute distress (per nurse report)

You may not qualify if:

• Pre-existing communication impairments
• Diagnosis of severe dementia or brain injury
• CAM-ICU positive for delirium
• unresponsiveness or inattention
• Aim 2:
• ≥18 years old
• Able to communicate in English
• Awake alert, responding appropriately to commands.
• Normal (aided or unaided) hearing and vision
• Able to control head, arm and hand movements
• Physiologically stable and in no acute distress (per nurse report)
• Intubated via oral endotracheal or tracheal tube without speaking valve, receiving mechanical ventilation
• Pre-existing communication impairments
• Diagnosis of severe dementia or brain injury
• CAM-ICU positive for delirium

Sponsors & Collaborators

• Ohio State University: lead
• Vidatak, LLC: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Nonverbal Communication; Critical Illness; Alzheimer Disease

Condition Hierarchy (Ancestors)

Communication; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Mary Beth Happ, PhD, RN
• Organization: The Ohio State University

happ.3@osu.edu

614-292-8336

Study Officials

• Mary Beth Happ, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research and Innovation

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: October 3, 2016
• Study Start: February 19, 2018
• Primary Completion: June 11, 2019
• Study Completion: June 11, 2019
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)