Assessment of the ACE Program for Rehabilitation in Heari... | NCT01846676

Studies
Assessment of the ACE Program for Rehabilitation in Hearing Loss

NCT01846676

Sponsor

University of Chile

Status

Completed

Last Update Posted

Jan 13, 2017Estimated

Enrollment

180Actual

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

Active Communication Education Program
Control

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 29, 2013

First Submission Date that Met QC Criteria

May 2, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 13, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Felipe Cardemil, Otolaryngology department, University of Chile, University of ChilePrincipal Investigator

Lead Sponsor

University of ChileOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In 2007 there was designed a rehabilitation program called ACE, which aims to improve rehabilitation directed to hearing aids users. The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.
Objective: To evaluate the utility of a standardized counselling program in patients with hearing loss.
Material and Methods: A before/after trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older with hearing loss diagnosed by pure tone audiometry will be included. To assess adherence we will use the IOI-HA scale.

Detailed Description

Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In Chile, hearing aids are provided by the State for elderly population. In 2007 there was designed a rehabilitation program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.
The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.
Objective: To evaluate the utility of a standardized counseling program in patients with hearing loss.
Material and Methods: A before/after clinical trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older diagnosed by pure tone audiometry who are beneficiaries of the Public GES hearing loss programme and receive a hearing aid will be included. The subjects will be randomized in two branches: Active branch, subject to the rehabilitation program; and passive branch, which was control, with usual management (no intervention). To assess adherence we will use the IOI-HA scale.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Program counseling	Active Comparator	Active branch, subject to the rehabilitation program	Behavioral: Active Communication Education Program
No counseling	Placebo Comparator	Passive branch, which was control, with usual management (no intervention).	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active Communication Education Program	Behavioral	The program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to the use of hearing aids in elderly population with hearing loss		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral hearing loss equal or higher than 40 decibels
Age 65 years old or more
Agree to be included in the study
Have a relative to go to the intervention with the subject

Exclusion Criteria:

Severe organic brain impairment
Physical or mental incapacity to understand the study questionnaires
Structural pathology of the ear that produces hearing loss as chronic otitis media, ear canal tumor, or tumor of the cerebellopontine angle

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felipe Cardemil, MD	University of Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barros Luco Trudeau Hospital		San Miguel, Santiago	Santiago Metropolitan	8900085	Chile

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided