| CTRI Number |
CTRI/2024/03/064162 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility assessment of mobile-based tele-rehabilitation in chronic respiratory disease patients |
|
Scientific Title of Study
|
A single-arm intervention trial to assess the feasibility of tele-rehabilitation for COPD patients through mobile-based intervention in Jodhpur, Rajasthan |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shirkant Dixit |
| Designation |
Undergraduate MBBS student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Community Medicine and Family Medicine, Academic building, AIIMS Jodhpur
Department of Community Medicine and Family Medicine
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7217844408 |
| Fax |
|
| Email |
shrikantdixit2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shirkant Dixit |
| Designation |
Undergraduate MBBS |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Community Medicine and Family Medicine, Academic building, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7217844408 |
| Fax |
|
| Email |
shrikantdixit2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shirkant Dixit |
| Designation |
Undergraduate MBBS |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7217844408 |
| Fax |
|
| Email |
shrikantdixit2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
ICMR, Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Shrikant Dixit |
AIIMS Jodhpur |
Department of Community Medicine and Family Medicine
Jodhpur
RAJASTHAN |
7217844408
shrikantdixit2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J439||Emphysema, unspecified, (2) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Smartphone and social media based pulmonary telerehabilitation |
Intervention will be delivered in the mode of videos through a smartphone. The exercise videos will be made in consultation with a physiotherapist and a pulmonologist and uploaded to a YouTube channel. The link of the video will be shared to different WhatsApp groups. There will be eight videos, each lasting eight to ten minutes. Participants will be instructed to exercise at least once daily using the videos. Total duration of the intervention will be two months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
People with COPD who were residing in any district of Thar Desert and had access to smartphones (either own or through family members) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| System Usability Scale and an adapted Technology Acceptance Model questionnaire to assess user acceptability |
Administered only at end line, at the end of intervention (8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The impact of the intervention on COPD severity & the changes in endurance & physical capacity will be assessed by EQ-5D-3L scale, COPD assessment test, 6-minute walk test & 30 second sit to stand test. The willingness of the patient to continue exercise in the future & the challenges faced by them will also be studied. |
COPD severity measurements will be administered both baseline & end line (after 8 weeks). Challenges will be assessed at end line only. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
25/03/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pulmonary tele-rehabilitation is emerging as one of the accessible and affordable means to deliver therapy to chronic respiratory disease patients. The Thar Desert has a total population of 16.6 million people, with a population density of 83 persons per square kilometer. It is sparsely populated with issues of transportation to the tertiary care centers, which further increases the need for tele-rehabilitation. |