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CTRI Number  CTRI/2024/09/073339 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A knowledge, attitude and practice (KAP) questionnaire related to occupational therapy for sleep management in neurological conditions  
Scientific Title of Study   Development and validation of a knowledge, attitude and practice (KAP) questionnaire related to occupational therapy for sleep management in neurological conditions among occupational therapist 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aathma S A 
Designation  Student (Masters of Occupational Therapy - Neuro Rehabilitation)) 
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8848680168  
Fax    
Email  aathma.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Shalini Quadros  
Designation  Assistant Professor - Senior scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8197579700  
Fax    
Email  shalini.quadros@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mrs Shalini Quadros  
Designation  Assistant Professor - Senior scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8197579700  
Fax    
Email  shalini.quadros@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions , Manipal Academy of higher Education , Manipal 
 
Primary Sponsor  
Name  Aathma S A 
Address  Department of Occupational Therapy,3rd floor, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Udupi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aathma S A  Manipal College of Health Professions, Manipal Academy of higher Education  Department of Occupational Therapy, 3rd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA
Udupi
KARNATAKA 
8848680168

aathma.mchpmpl2023@learner.manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Occupational therapist working with neurological conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Occupational therapists who are currently practicing with adult neurological conditions in India.
Occupational therapists who are working in inpatient settings, outpatient settings, and/or home health settings.
Occupational therapists who have minimum of 1 year of experience working with adult neurological conditions along with/without other conditions.
 
 
ExclusionCriteria 
Details  Occupational therapists who work purely in academic settings. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge, Attitude, and Practice (KAP) Questionnaire related to Occupational Therapy for Sleep Management in Neurological Conditions among Occupational Therapists  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size
Modification(s)  
Total Sample Size="50"
Sample Size from India="50" 
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)   22/10/2024 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Detailed Description of the Procedure


After obtaining approval from CTRI, the questionnaire obtained after face validity will be converted to an online version for content validation. An email will be sent to subject experts (three occupational therapists, one psychologist and one language expert) with the details of the study and requesting to participate as an expert for validating the questionnaire. If interested the experts will be requested to click on a link which would direct them to a Google form that collects demographic details and whether they accept or deny participating in the study. Once accepted, an email will be sent to the interested experts with a link to consent form. Once consented, the form will lead to the questionnaire with a grid to score for relevance, clarity, and appropriateness. Once submitted, the scores will be received by the tester and further analysis will be done for content validity. The evaluation will be based on Item – content validity index (I – CVI) and the cut-off points for analysis will be I –CVI > 0.80 as appropriate. If the accepted value is > 0.80, will proceed with construct validity. Revision will be made to the questionnaire based on the suggestions and inputs from the subject experts.

The revisions will be incorporated and an online Google form with the questionnaire items in it. This revised questionnaire after content validity will be submitted to IEC for approval. Once the approval is received, the questionnaire will be sent to 50 occupational therapists identified who work with neurological conditions through email. An online link will be provided regarding the details of the study, inclusion-exclusion criteria, confidentiality and anonymity of their responses and an invite to participate in the study. Participants will be asked to continue which will direct them to a consent form. On agreeing to participate in the study, the participants will be directed to the Google form that will collect data on KAP regarding sleep management. On clicking submit, the responses will be received for further analysis. The responses will be statistically analyzed to obtain the construct validity of the developed questionnaire. This will be followed by thesis and manuscript writing and lastly submission of the thesis and manuscript.

 
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