Dolores One: Maximizing Functional Communication for Adults

NCT03934619 | Withdrawn DMC

• 1 other identifier: HP-00078386
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Difficulties with communication for patients requiring mechanical ventilation is known to be a source of distress in the acute care setting. The inability to speak has been associated with increased psychological distress and increased feelings of fear and anger and impact negatively on patient participation with caregivers and their overall recovery. Developing and maintaining communication between patients and hospital staff reduces patient stress and increases patient satisfaction and part of the standard pf care. According to the new and revised The Joint Commission standards, hospitals must identify and document patients' communication needs and communicate with patients during their care in a manner that meets those needs. Using the Dolores One device for patients can improve the ease and efficiency of communication while they are in the acute care setting. For non-speaking patients, nonverbal communication means are often used, including mouthing words and head nods to indicate yes/no responses. However, relying completely on nonverbal means can limit patient responses and lead to ineffective and frustrating communication exchanges. There have been several studies reviewing the negative effects of the inability to speak for intubated, mechanically ventilated patients. However, there is a need for more research to address communication difficulties in other mechanically ventilated populations, including patients receiving non-invasive ventilation and ventilator dependent tracheostomy patients. The Dolores One is comprised of an acoustic throat sensor and positioned at the patient's neck with a soft adjustable collar. The sensor gathers vocal cord vibrations and transmits signals to a control unit, processes the sensor signal, and finally, generates the patient's voice. The smart signal processing automatically accommodates both weak forced voices and whispers, producing a voice output to allow for normal conversation in a patient's natural voice, free from the sounds of rushing air or equipment noises secondary to Non-Invasive Mechanical Ventilation (NIMV) systems. The purpose of the study is to determine if the Dolores One devices can be used in the clinical acute care setting with patients in NIMV to improve their ability to communication as measured as ease to communicate and intelligibility, with family and the members of the medical team.

Conditions

Communication

Outcome Measures

Primary Outcomes (2)

• Change in the Easy of Communication Scale

  Easy of Communication Scale is a self reported 10 item questionnaire where the subjects rate their perception of the ease to communicate. It is scored on a 5 point likert scale (0 to 4) with a range of 0-40. The investigators are examining the change in communication without and with the use of the Dolores One device. The higher the score the more difficulty the subject perceives it is to communicate with other.

  Testing is at baseline, and 24-36 hours after use of the Dolores One

• Change in the Intelligibility Subscale of the Frenchay Dysarthria Assessment Tool

  The Intelligibility Score is a subscale of the Frenchay Dysarthria Assessment Tool that examines motor speech deficits. The Intelligibility Subscales examines the precision of articulation. This subscale involves the subject speaking 5 randomized short phrases and the intelligibility is scored as a yes / no based upon accuracy of a volunteer repeating the phrase accurately. The subscale has a range of 0-5 with 5 being normal and has a minimally detectable change of 1 being significant.

  Testing is at baseline and 24 to 36 hours after use of the Dolores One

Study Arms (1)

Intervention

EXPERIMENTAL

Convenient cohort, non-randomized group will be enrolled to examine the effects of the Dolores One on improving the ease of communication and intelligibility

Device: Dolores One

Interventions

Dolores One DEVICE

Dolores One, which is a will be applied personal sounds amplification device, will be used to determine if it improves the ability to communication and improves intelligibility

Intervention

Eligibility Criteria

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

You may qualify if:

• Requires NIMV
• Uses a full face mask
• Using a University of Maryland Medical Center (UMMC) device
• Medically stable as determined by the medical team (register nurse (RN) and licensed independent provider)
• The patient is stable on NIMV which measure same settings for a period 30 to 90 minutes as per RT guidelines
• Glasgow Coma Scale (GCS) 15
• Subjects speak English
• Skin is intact in the area where the Dolores One would be placed.

You may not qualify if:

• Patient is unable to consent self for the study
• Pre-existing speech, language, voice or cognitive deficits
• NIMV setting that exceeds the following prescription: FIO2 \> .60; Peep \> 12 mmHg, inspiratory pressure \> 15 mmHg

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• Happ MB, Garrett K, Thomas DD, Tate J, George E, Houze M, Radtke J, Sereika S. Nurse-patient communication interactions in the intensive care unit. Am J Crit Care. 2011 Mar;20(2):e28-40. doi: 10.4037/ajcc2011433.

  PMID: 21362711 BACKGROUND

• Khalaila R, Zbidat W, Anwar K, Bayya A, Linton DM, Sviri S. Communication difficulties and psychoemotional distress in patients receiving mechanical ventilation. Am J Crit Care. 2011 Nov;20(6):470-9. doi: 10.4037/ajcc2011989.

  PMID: 22045144 BACKGROUND

• Magnus VS, Turkington L. Communication interaction in ICU--Patient and staff experiences and perceptions. Intensive Crit Care Nurs. 2006 Jun;22(3):167-80. doi: 10.1016/j.iccn.2005.09.009. Epub 2005 Nov 17.

  PMID: 16298132 BACKGROUND

• Patak L, Wilson-Stronks A, Costello J, Kleinpell RM, Henneman EA, Person C, Happ MB. Improving patient-provider communication: a call to action. J Nurs Adm. 2009 Sep;39(9):372-6. doi: 10.1097/NNA.0b013e3181b414ca. No abstract available.

  PMID: 19745632 BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chris L Wells, PhD, PT

  Univeristy of Maryland Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EBP & Research Coordinator

Model Details: This study will be a prospective study using a convenient cohort of 55 adult patients, who was using NIV, to pilot the effectiveness of the Dolores One to improve verbal communication. There will be no randomization and no control group. The design is a pretest / posttest mixed method in which the Easy of Communication Scale and the Intelligibility section of the Frenchay Dysarthria Assessment will be administered at base line and repeated once the Dolores One has been set up on the patient.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 2, 2019
• Study Start: October 7, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years
• Access Criteria: Professional Speech conference; possibly respiratory therapy conference. Will also be shared within our organization as it relates to use of the device is we have positive findings

Locations

US (1)