| CTRI Number |
CTRI/2024/08/072732 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pre-post intervention study] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Use of a Training Program for College Students on Recognizing Swallowing Difficulties During Meals |
|
Scientific Title of Study
|
Assessing the Effectiveness of an Educational Intervention in Non-Healthcare College Students on Identifying Aspiration during Oral Feeds in Individuals with Dysphagia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC KMC MLR 04/2024/215 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aroline Juan Amanna |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Audiology and Speech-Language Pathology Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal,
Karnataka, India-576104
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
8123428962 |
| Fax |
|
| Email |
aroline.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetie Shetty A |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Audiology and Speech-Language Pathology Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal,
Karnataka, India-576104
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
8197759358 |
| Fax |
|
| Email |
preetie.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetie Shetty A |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Audiology and Speech-Language Pathology Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal,
Karnataka, India-576104
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
8197759358 |
| Fax |
|
| Email |
preetie.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Audiology and Speech-Language Pathology Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104 |
|
|
Primary Sponsor
|
| Name |
Aroline Juan Amanna |
| Address |
Department of Audiology and Speech-Language Pathology Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Preetie Shetty A |
Department of Audiology and Speech-Language Pathology Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104 |
| Dr Vivek Gopinathan |
Department of Emergency Medicine, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aroline Juan Amanna |
Kasturba Medical College Mangalore |
Department of Audiology and Speech-Language Pathology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104
Dakshina Kannada
KARNATAKA |
8123428962
aroline.mchpmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Pre-post intervention study |
Administration of a pre-multiple-choice questionnaire, followed by educational awareness/training material, and then a post-multiple-choice questionnaire.
The intervention will be completed over single session (frequency of intervention: 1 time intervention) which will be completed over a duration of 60 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Students from Bachelor’s and Master’s courses
|
|
| ExclusionCriteria |
| Details |
1.Students of healthcare courses
2.English language not included in the curriculum since 5th grade
3.Reports of uncorrected sensory deficits
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study result will measure the efficacy of the developed educational material in creating awareness among non-healthcare college-going students about the causes and symptoms of aspiration, and the management strategies available to counteract aspiration in individuals with dysphagia during oral feeds. |
Pre-post measurement: within 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measure the effectiveness of the developed educational awareness material |
Pre-post measurement: within 1 week |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This pre-post intervention study aims to develop and validate educational awareness materials to help non-healthcare college students identify aspiration events in individuals with dysphagia during oral feeds. The study begins with creating a PowerPoint presentation that covers the causes of aspiration, red flag symptoms, potential consequences, management strategies, and appropriate healthcare-seeking behavior which can be used to educate the participants of the study. Additionally, a 15-item multiple-choice questionnaire will be developed. The finalization of these educational materials will be achieved through the Nominal Group Process. Participants will be selected using a stratified sampling method and organized into batches of 10 for the awareness sessions. Each session will start with administering a pre-multiple-choice questionnaire, followed by the educational presentation and open discussions to clarify any uncertainties. A post-multiple-choice questionnaire will then be administered to measure the participants’ awareness levels before and after the session. The study aims to evaluate the effectiveness of the educational material in increasing awareness among non-healthcare college students about the causes, symptoms, and management strategies of aspiration. Early identification of aspiration red flags in individuals with dysphagia is expected to lead to timely consultations with specialists and improved patient outcomes. |