| CTRI Number |
CTRI/2023/01/048726 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing and Formulating a Questionnaire to Identify the difficulties Faced by Community Dwelling Elderly in Goa in Availing Physiotherapy Treatment: A Mixed Method Study |
|
Scientific Title of Study
|
Development and Validation of a Questionnaire to Determine Barriers that Affect Adherence to Physiotherapy Treatment among Community Dwelling Elderly of Goa: A Mixed Method Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashlesha Padte |
| Designation |
First year Master of Physiotherapy |
| Affiliation |
Goa Medical College |
| Address |
Goa Medical College, Bambolim Goa
Goa Medical College, Bambolim Goa
North Goa
GOA
403107
India |
| Phone |
7875225029 |
| Fax |
|
| Email |
physioaashlesha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jorida Fernandes |
| Designation |
Lecturer in Physiotherapy |
| Affiliation |
Goa Medical College |
| Address |
Goa Medical College, Bambolim Goa
Goa Medical College, Bambolim Goa
South Goa
GOA
403708
India |
| Phone |
9060778888 |
| Fax |
|
| Email |
jorida4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jorida Fernandes |
| Designation |
Lecturer in Physiotherapy |
| Affiliation |
Goa Medical College |
| Address |
Goa Medical College, Bambolim Goa
Goa Medical College, Bambolim Goa
South Goa
GOA
403708
India |
| Phone |
9060778888 |
| Fax |
|
| Email |
jorida4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Goa Medical College |
| Address |
Bambolim Goa |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ashlesha Padte |
Goa Medical College |
Department of orthopaedics
Bambolim Goa
North Goa
GOA |
7875225029
physioaashlesha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Goa Medical Collge |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Community dwelling elderly (>65 years of age) residing in Goa who have received physiotherapy treatment for any impairment after attaining/entering geriatric age (>65 years of age) from July 2022 to July 2023.
2.Participants willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1.Participants with psychological problems like dementia, depression, psychosis.
2.Language problems like vocal disturbances, difficulty understanding the language, hearing impairments making it difficult to understand.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of Questionnaire |
At Baseline, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Validated Questionnaire |
6 months after Development of Questionnaire |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/01/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a cross sectional observational study aimed to develop and validate a questionnaire focusing on identifying the barriers that affect adherence to physiotherapy treatment in community dwelling elderly in Goa. The data collected using this questionnaire can then be used to formulate policies that can help the elderly to avail the physiotherapy treatments easily. Identifying the barriers will help formulate treatment strategies that are easily accessible and can help change attitude of elderly towards exercise and physiotherapy. |