| 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
|
|
|
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
|
|
|
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
|
|
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. |