| CTRI Number |
CTRI/2024/11/076708 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing a Questionnaire to Assess Occupational Therapists Knowledge, Attitudes, and Practices in Activities of Daily Living for Individuals with Hand Injuries |
|
Scientific Title of Study
|
Development and validation of occupational therapists knowledge, attitude, and practice questionnaire in activities of daily living among individuals with hand injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
karthikeyan |
| Designation |
postgraduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9944593683 |
| Fax |
|
| Email |
karthikeyan.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Koushik Sau |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7760064744 |
| Fax |
|
| Email |
koushik.sau@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Mr Koushik Sau |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7760064744 |
| Fax |
|
| Email |
koushik.sau@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
karthikeyan E |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka, India 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shovan Saha |
Kasturba Medical College and Kasturba Hospital Manipal |
N1 Block, Department of Occupational Therapy, Manipal, Udupi, Karnataka, India 576104 Udupi KARNATAKA |
9880059426
shovan.saha@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-2 (STUDENT RESEARCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Occupational therapists who are working with adult hand injury individuals in India |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for content validation:
1. Occupational therapist who has five years of clinical experience with adult hand injury individuals in India
Inclusion criteria for construct validation:
1. Occupational therapists who are working with adult hand injury individuals in India
2. Occupational therapist practicing in orthopedics with one or more than one year of experience in India
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for construct validation:
1. Occupational therapists who are working only in academic settings
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Development and Validation of the knowledge, attitude, and practice (KAP) survey questionnaire. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="149" Sample Size from India="149"
Final Enrollment numbers achieved (Total)= "149"
Final Enrollment numbers achieved (India)="149" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
16/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim of the study: To develop and validate the occupational therapists knowledge, attitude, and practice questionnaire in activities of daily living among individuals with hand injuries.
Justification for study: In a country as diverse as India, values and beliefs underlying an individual’s culture are known to influence the ADLs they engage in their daily life, and for those individuals, ADL is important; so far, there is no information regarding the Indian occupational therapist practices. These ADLs are important domains an occupational therapist addresses during their treatment. Hence, there is a need
Tools used: An online questionnaire will be developed to assess the occupational therapists’ knowledge, attitude, and practice in activities of daily living among individuals with hand injuries. The questionnaire will consist of four sections: demographics, knowledge, attitude, and practice
Detailed description of procedure: The study will be conducted in three phases. In Phase I, after the approval from the IEC, the KAP questionnaire will be developed based on the literature review focusing on three main areas: occupational therapy, hand injury, and activities of daily living. The questionnaire will consist of four sections: demographics, knowledge, attitude, and practice. After that, content and construct validation will be done. In Phase II, for content validation, occupational therapists and psychologists from India will be selected through personal contacts and college websites and they will be contacted through email. Initially, ten occupational therapists from India will be selected, among them the first five occupational therapists, who have a minimum five years of clinical experience in adult hand injuries, and one psychologist will review the questionnaire. Links to the consent and validation forms will be emailed with instructions. A four-week response period will be allowed, with weekly reminders. If needed, additional experts will be selected from the remaining five therapists. Feedback will be collected, and the questionnaire will be revised accordingly. In Phase III, for construct validity, occupational therapists will be selected from the AIOTA website, colleges, and LinkedIn profiles and through a snowball sampling method. The sample size will include 149 occupational therapists from India, selected using convenience and snowball sampling methods. Occupational therapists who treat hand injuries will be eligible to participate. The Exploratory factor analysis will analyze construct validity. Google Forms will format the KAP questionnaire and consent form links, distributed via social media and email. Recipients of the forms will be encouraged further to distribute them among other occupational therapists. Data will be collected in Excel sheets and analyzed using JAMOVI software (version 2.3). The categorical variables in the study will be described
using frequency tables and percentages. The numerical variables will be
assessed using mean and standard deviation or median and interquartile range
subject to assessments of skewness. Two-sample independent t-test/one-way ANOVA
or its non-parametric variants (subject to violation of normality and
homogeneity of variance assumption) will be used to facilitate comparisons of
the outcome characteristics across groups.
The reliability statistics will be assessed using Cronbach’s alpha and
construct validity will be measured using Factor Analysis. The Content Validity
Index will enable us to assess the content validity of the structured
questionnaire developed in the study.
All statistical analysis will be carried out at 5% level of significance, 80%
power using Jamovi 2.3.28 |