| CTRI Number |
CTRI/2021/09/036869 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Pretest-Posttest |
| Study Design |
Other |
|
Public Title of Study
|
Video educational module on hearing aid handling skills |
|
Scientific Title of Study
|
Effectiveness of Video Educational Module on Individual’s Hearing Aid Handling Skills |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Gupta |
| Designation |
Post graduate student |
| Affiliation |
Manipal college of health professions, MAHE, Manipal |
| Address |
Department of Speech & Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9717131297 |
| Fax |
|
| Email |
shubham.gupta@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of health professions, MAHE, Manipal |
| Address |
Department of Speech & Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845384136 |
| Fax |
|
| Email |
g.kanaka@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of health professions, MAHE, Manipal |
| Address |
Department of Speech & Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845384136 |
| Fax |
|
| Email |
g.kanaka@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Shubham Gupta |
| Address |
Department of speech and hearing, Manipal College of Health Professions, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shubham Gupta |
Kasturba Hospital Manipal |
Department of Speech & Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9717131297
shubham.gupta@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Hearing aid user experience: Novel hearing aid user |
|
| ExclusionCriteria |
| Details |
Hearing aid user with multiple disabled
Experienced hearing aid user
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre and post test HASKI scores measured in percentage explains the competence level |
1 - pre test HASKI score ( Baseline at the time of fitting)
2 - post test HASKI score ( 3 weeks after the hearing aid fitting) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study intended to assess the efficacy of video educational module in enhancing
the novel hearing aid users device handing skills, maintenance, and taking care
of their device. To achieve this, good quality and comprehensive video module
on hearing aid care, maintenance will be developed and provided to the selected
target population. Prior to that, all the participants will fill the HASKI
(Hearing aid skills and knowledge inventory) questionnaire post-hearing aid
fitting and counseling. Later, after 3 weeks of the washout period, the same
participants will be made to watch the video module and HASKI will be readministered.
The difference between pre and post-video module HASKI score will indicate the
efficacy of the video training module. |