| CTRI Number |
CTRI/2024/08/072190 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the effects of video based learning with a help of an expert, in improving the patients knowledge on a long term lung disease which is mainly caused by cigarette smoking, who are admitted to the hospital. |
|
Scientific Title of Study
|
Effectiveness of Expert Assisted Video-Based Learning on disease-specific knowledge among hospitalized Chronic Obstructive Pulmonary Disease Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Anirudh R Bhat |
| Designation |
MSc Respiratory Therapy |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department of Respiratory Therapy, 4th floor, MCHP, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8431923887 |
| Fax |
|
| Email |
anirudhrbhat1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Madhura Reddy |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Respiratory Therapy, 4th floor, MCHP, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8660196105 |
| Fax |
|
| Email |
madhura.reddy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Madhura Reddy |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Respiratory Therapy, 4th floor, MCHP, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8660196105 |
| Fax |
|
| Email |
madhura.reddy@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal 576 104, karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Mr Anirudh R Bhat |
| Address |
Department of Respiratory Therapy, 4th floor, Manipal College of Health Professions, MAHE, Manipal,Udupi district, karnataka, India,Pincode- 576104 |
| 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 |
| Dr Manu Mohan K |
Kasturba Medical College |
D2, D3, D4 Pulmonary Wards, Department of Respiratory Medicine
Udupi
KARNATAKA |
9964896253
Manu.mohan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Expert Assisted Video-Based Learning |
In phase 1, A video will be developed for the expert assisted Video based learning and the content in the video will be as per the contents of Bristol COPD Knowledge Questionnaire. In Phase 2, After receiving consent from the patient, the Baseline knowledge will be assessed with Bristol Questionnaire and a video will be showed to the patients and the doubts within the video will be clarified by an Expert. After 48 hours of the intervention, Bristol Questionnaire will be readministered to assess the retention of the knowledge. |
| Comparator Agent |
not applicable |
As this is a single arm study, we are not comparing the effects of video-based learning on any control group. hence comparator agent is not applicable in this current study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with physician-diagnosed COPD as per GOLD criteria
2.Patients who can speak and read in the Kannada language.
3.Conscious, oriented, hemodynamically stable patients on room air, intermittent oxygen therapy, and non-invasive ventilation (NIV)
|
|
| ExclusionCriteria |
| Details |
1.Patients admitted to the Intensive care unit (ICU)
2.Patients with Asthma or Asthma COPD overlap syndrome (ACOS)
3.Intellectual disability, Visual, and Auditory impairment
4.Patients on invasive or continuous non-invasive ventilation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The changes in BCKQ scores, before and after the Expert-Assisted Video-based (EAV) intervention. |
before receiving the intervention (day 0) and after 48 hours of receiving expert assisted video training (day 2). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| scores obtained in the questionnaire and the change at two time points. |
baseline score at day 0 - before receiving intervention and after 48 hours of receiving expert assisted video training (day 2). |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
15/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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
|
Chronic Obstructive Pulmonary Disease is a combination of Chronic Bronchitis and Emphysema and treating it involves 90% of Education and 10% of Medication. Educating COPD Patients can increase patient awareness on symptom control and also helps in reducing the incidence of exacerbation. This study aims to assess the effectiveness of Expert Assisted Video-based Learning on the retention of Disease specific Knowledge among hospitalized Chronic Obstructive Pulmonary Disease Patients. Primary objective is to assess the Baseline and Retained Knowledge through Expert Assisted Video-Based Learning. The Proposed Sample Size is 58 participants. The Patients with COPD will be recruited for the study based on the inclusion and Exclusion Criteria after obtaining the consent. The Baseline Knowledge of the patient will be assessed with the help of Bristol COPD Knowledge Questionnaire and Video based Intervention will be given. Any doubts within the video will be clarified by an Expert. The retention of Knowledge will be assessed with the same Bristol Questionnaire after 48 hours of the intervention. Analysis of the result will be done using paired t-test or one-way ANOVA, to obtain any statistical significance. |