Evaluation of the Quality of Life After a Multidisciplinary Auditory Rehabilitation Program (EQUAPRAP)

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

In 2008, the Handicap-Santé survey counted 10 million people with hearing difficulties in France, i.e. 16% of the national population. For 5.4 million of these people, the hearing limitations considered to be moderate to total, are likely to have repercussions on their daily life.

In 2010, 600,000 people with hearing loss wore hearing aids, including 360,000 with very severe to total limitations who were unable to follow a conversation with others.

Hearing loss can impact hearing skills (comprehension in noisy environments or with multiple speakers) and be a source of cognitive decline. It can also limit the quality of exchanges, communication and information taking.

Several studies have shown that hearing loss can also have a negative effect on quality of life, psychological well-being, personal fulfillment, social relationships and can lead to social isolation, depression and/or anxiety.

Currently, the treatment of people with hearing loss is often limited to hearing aids from a hearing aid specialist. Hearing rehabilitation and lip-reading training with a speech therapist may be offered at a later stage. However, many people who have been fitted with a hearing aid describe a decrease in their quality of life despite the fitting.

Current treatment seems to deal mainly with auditory-cognitive problems. To date, no multidisciplinary rehabilitation services seem to be offered in France to take into account the other consequences of this condition: anxiety, depression, and limitations in social participation.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpital Sainte-Marie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acquired hearing loss (mild, moderate, severe or profound), with hearing aid, participating in a complete rehabilitation program between November 2015 and June 2021.

Description

Inclusion Criteria:

  • Patients whose age ≥ 18 years
  • Patients with acquired hearing loss (mild, moderate, severe or profound)
  • Patients with hearing aids
  • Patients participating in a complete rehabilitation program
  • Patients who master the French language

Exclusion Criteria:

  • Patients with proven cognitive impairment
  • Implanted patients
  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under court protection
  • Interruption of the rehabilitation program before a minimum of 6 half-days of HDJ
  • Patients objecting to the use of their data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of multidisciplinary rehabilitation on the quality of life of adults with hearing aids
Time Frame: Month 1
This outcome corresponds to the Change in quality of life measured with the ERSA scale before and after rehabilitation.
Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient profile of age
Time Frame: Month 1
This outcome corresponds to the number of age categories
Month 1
Patient profile of type of hearing loss
Time Frame: Month 1
This outcome corresponds to the number of type of hearing loss.
Month 1
Patient profile of severity
Time Frame: Month 1
This outcome corresponds to the type of severity.
Month 1
Quality of life of patients
Time Frame: Month 1
This outcome corresponds to the overall quality of life, personal life, social life and work life of the assessment of the impact of deafness in adults. is a self-administered questionnaire. It is divided into 4 domains, each comprising 5 questions graded from 1 to 10. The questions are simple, and formulated so patients will answer according to how they feel at the actual time of the session.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Collaborators

Sainte-Marie Hospital

Investigators

  • Principal Investigator: Pierre SAFAR, MD, Hôpital Sainte-Marie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

August 15, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EQUAPRAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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