Virtual team-based clinic for Hearing Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Hearing Loss
Virtual team-based clinic - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether remote visits are possible for pediatric cochlear implant patients.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Virtual team-based clinic will improve 6 primary outcomes and 8 secondary outcomes in patients with Hearing Loss. Measurement will happen over the course of Up to 1 year.

Up to 1 year
Auditory Skills Checklist (ASC) scores
Behavior Assessment System for Children version 3 (BASC-3) scores
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
Datalogging
Electrically evoked compound potential values
Electrode Impedances
Generalized Anxiety Disorder version 7 (GAD-7) scores
LittleEars questionnaire scores
Parenting Stress Index/Short Form (PSI) scores
Parenting Stress-CI scores
Patient Health Questionnaire version 8 (PHQ-8) scores
Quality of Life- CI (QoL-CI) scores
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores
Threshold/Upper stimulation levels

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Pediatric Cochlear Implant Candidate Group
1 of 2
Established Cochlear Implant Recipient Group
1 of 2
Experimental Treatment

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Virtual Team-based Clinic is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Pediatric Cochlear Implant Candidate Group
Behavioral
Participants who are in the process of receiving standard of care cochlear implant evaluation. Participants will receive a virtual team-based clinic as a part of the candidacy evaluation process for one year.
Established Cochlear Implant Recipient GroupParticipants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year for reporting.

Who is running the study

Principal Investigator
C. S.
Prof. Chrisanda Sanchez, Assistant Professor
University of Miami

Closest Location

University of Miami - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
will have a cognitive evaluation, as part of their candidacy evaluation show original
Ages 1-12 who have at least six months of experience with a company that has the ability to program remotely. show original
Parents with English-speaking children can seek health care at this clinic show original

Patient Q&A Section

How many people get hearing loss a year in the United States?

"The National Health and Nutrition Examination Survey 2011 to 2012 shows that hearing loss in the U.S. affects 5.3 million - 1 in 6 people. Of those, approximately 2 per 1000 men and 1 in 1000 women are currently hearing impaired. It is predicted that as the U.S. population grows, this rate will increase. However, given the high prevalence of hearing loss, many strategies must be implemented over the next 20 years to promote hearing conservation, prevent hearing loss and improve the quality of life of these individuals." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hearing loss?

"Hearing aids are rarely prescribed for patients with hearing loss as they have low efficacy. Hearing aid users do not report the usual benefits of listening to their hearing aids. Appropriate communication is often hampered by the presence of hearing loss so the use of hearing aids for patients with hearing loss is an appropriate treatment for selected patients." - Anonymous Online Contributor

Unverified Answer

What causes hearing loss?

"Hearing loss is present at birth, and is progressive throughout life. The most common cause is birth injury, which can be caused by trauma to the ear. Other causes include acoustic trauma, noise pollution, noise in the workplace, and tobacco." - Anonymous Online Contributor

Unverified Answer

What is hearing loss?

"Hearing loss is a common condition that can be caused by age-related changes in a person's auditory system. The most common type of hearing loss experienced is that caused by hearing loss. More than 90% of patients over the age of 60 years have some degree of hearing loss. Hearing loss, however, doesn't usually result in problems with social functioning or other problems. Hearing loss is a reversible condition and people with a hearing loss can learn to make the most of the hearing loss.\n" - Anonymous Online Contributor

Unverified Answer

Can hearing loss be cured?

"A Cochrane review found no evidence of a cure for hearing loss, with the possibility of an improvement or stabilization in hearing loss. Cochrane reviews do not provide evidence of treatment effectiveness for people with hearing loss." - Anonymous Online Contributor

Unverified Answer

What are the signs of hearing loss?

"Hearing loss typically is unilateral, and presents with one or more of the following symptoms: unilateral and sudden hearing loss in one or both ears, ringing in the ears, tinnitus and distortion of hearing. Patients with bilateral loss and a history of meningitis may have symptoms of auditory nerve involvement." - Anonymous Online Contributor

Unverified Answer

Does virtual team-based clinic improve quality of life for those with hearing loss?

"The VT clinic increased the quality of life for all patients and families in the VT group. Since the cost of the equipment was low and required little maintenance, the clinic may have a lower cost and greater applicability to a larger population than other similar services. Furthermore, our evaluation raises the need for future investigation of the effectiveness of VT clinics in other health care settings where technology is readily available." - Anonymous Online Contributor

Unverified Answer

Is virtual team-based clinic typically used in combination with any other treatments?

"The findings of this study suggest that virtual team-based clinic is used as a treatment and has a positive effect on the outcome of patients with CRS." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hearing loss?

"There is a continuing concern for the prevention and treatment of disabling hearing loss. Research for hearing is being conducted on countless types of topics including the etiology of hearing loss, its effects on the health of adults and children, and approaches for preventing and reversing it. The hearing losses, meanwhile, continue to be a major cause of human suffering and disability, especially when combined with age-related conditions. There was little or no significant information in the research reviewed in 2003 and 2004. New research should be expected soon, with the caveat that much is still unknown about these processes." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of virtual team-based clinic?

"The side effects of this intervention were not significantly different from other conditions or from health care. We were only able to identify few side-effects, which might indicate high levels of compliance and positive response from the participants. Furthermore, most of the reported side effects were mild or transient, unlike the serious and persistent nature of symptoms seen in some other interventions such as drug therapy, or surgery among most patients. The most commonly reported side effects were: dizziness, fatigue or exhaustion (65%), nausea, headaches and dizziness (64%), blurred vision or light sensitivity (54%), and decreased alertness (47%). The most severe side effect was mild to moderate short term memory loss (6%)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving virtual team-based clinic?

"There are many variables that are considered in the study. We did not show a difference in the hearing loss change when compare the two methods and the number of our participants didn’t enable us to reach significant results. But we can’t ignore that hearing loss in the elderly can be much more troublesome; therefore, more studies on similar subjects are needed." - Anonymous Online Contributor

Unverified Answer

What does virtual team-based clinic usually treat?

"Data from a recent study offers insight into the current state of practice of physicians who are using the virtual clinic model. It is important for medical educators to equip physicians with the tools needed to implement and sustain virtual teams. This will help physicians to better train and provide services in a cost effective and more convenient manner." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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