Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Communication Education Program
Control
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Aged, Hearing Aids, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Hearing loss worst than 40 db in the better ear
- 65 years old or more
Exclusion Criteria:
- Dementia
- Prior surgery for hearing loss
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
This group received an audiological rehabilitation program with a tele-educative intervention boost
This group received no intervention
Outcomes
Primary Outcome Measures
Adherence to the hearing aid
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT02264314
First Posted
October 8, 2014
Last Updated
January 11, 2017
Sponsor
University of Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
1. Study Identification
Unique Protocol Identification Number
NCT02264314
Brief Title
Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss
Official Title
Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. However, there are reports of adherence to the use of hearing aids of only to 40%. The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids. A randomized controlled trial was performed. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization.
Detailed Description
Introduction: Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. Delivery of hearing aids to older adults with bilateral hearing loss is included in the Garantías Explícitas en Salud (GES) Guidelines of Chile. However, there are reports of adherence to the use of hearing aids of only to 40%. The GES guideline establishes the conducting of programs in audiological rehabilitation counseling, but there is no evidence that this is being developed in Chile.
Objective: The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids.
Material and Methods: A randomized controlled trial was performed. Demographic and audiometric variables were recorded. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization. The primary outcome will assess adherence to the use of hearing aids. Secondarily related quality of life was assessed with hearing loss.
Analysis Plan: Data will be analyzed mediantes bivariate tests, student t for normally distributed continuous variables, and Fisher exact test for categorical variables. A model of multilevel mixed effects will be drawn considering the repeated measurements of outcomes assessed. For all analysis is considered an alpha=5%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Aged, Hearing Aids, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group received an audiological rehabilitation program with a tele-educative intervention boost
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This group received no intervention
Intervention Type
Behavioral
Intervention Name(s)
Active Communication Education Program
Other Intervention Name(s)
ACE Program
Intervention Description
A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Regular assistance
Intervention Description
Participants in this arm will not receive intervention during the study protocol time. After the completion of the protocol, they will receive the same intervention that the intervention group, meaning the ACE program intervention.
Primary Outcome Measure Information:
Title
Adherence to the hearing aid
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hearing loss worst than 40 db in the better ear
65 years old or more
Exclusion Criteria:
Dementia
Prior surgery for hearing loss
12. IPD Sharing Statement
Learn more about this trial
Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss
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