| CTRI Number |
CTRI/2024/11/077203 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EDUCATION OF INHALER TECHNIQUE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Impact of Video and Pamphlet Education on Inhaler Techniques in Patients with Breathing Disorders |
|
Scientific Title of Study
|
Effectiveness of video teaching vs pamphlet on inhalation techniques among patients with Obstructive airway disease in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIRTHAVALLI G |
| Designation |
NURSING OFFICER |
| Affiliation |
|
| Address |
ROOM NO 7 GROUND FLOOR
DEPARTMENT OF PULMONARY MEDICINE
AIIMS BIBINAGAR
YADADRI BHONGIR
Hyderabad
TELANGANA
508126
India |
| Phone |
9591747815 |
| Fax |
|
| Email |
amirtha407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMIRTHAVALLI G |
| Designation |
NURSING OFFICER |
| Affiliation |
|
| Address |
ROOM NO 7 GROUND FLOOR
DEPARTMENT OF PULMONARY MEDICINE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS) BIBINAGAR
YADADRI BHONGIR
TELANGANA
508126
India |
| Phone |
9591747815 |
| Fax |
|
| Email |
amirtha407@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMIRTHAVALLI G |
| Designation |
NURSING OFFICER |
| Affiliation |
|
| Address |
ROOM NO 7 GROUND FLOOR
DEPARTMENT OF PULMONARY MEDICINE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
AIIMS BIBINAGAR
YADADRI BHONGIR
TELANGANA
508126
India |
| Phone |
9591747815 |
| Fax |
|
| Email |
amirtha407@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS) BIBINAGAR |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| AMIRTHAVALLI |
AIIMS BIBINAGAR |
DEPARTMENT OF PULMONARY MEDICINE,
AIIMS, BIBINAGAR, YADADRI BHONGIR, TELANGANA. PIN-508126
Hyderabad
TELANGANA |
9591747815
amirtha407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BBN-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, (2) ICD-10 Condition: J40||Bronchitis, not specified as acuteor chronic, (3) ICD-10 Condition: J439||Emphysema, unspecified, (4) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIRECT DEMONSTRATION+PAMPHLET |
Experimental group 2 will be receiving instruction on inhalation technique through direct demonstration and pamphlet will be shared. |
| Intervention |
DIRECT DEMONSTRATION+VIDEO |
Experimental group 1 will receive instruction on inhalation technique through video teaching with direct demonstration and also video will be shared to them |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18years
2.Established diagnosis of OAD which include Asthma, COPD, bronchiolitis, Post TB sequelae with Obstructive airway disease (TOPD) and Bronchiectasis.
3.Inhaler prescribed by Physician which include p MDI and DPI
4.Diagnosed OAD patients with in1year
5.Access the smart phone for watching the educational video
|
|
| ExclusionCriteria |
| Details |
1.Patients with severe dyspnea, confusion due to hypoxemia
2.Patients on nebulisation
3.Psychiatric patients
4.Active TB
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.This study will provide the guidelines for the nurses to practice the evidence based teaching method in improving inhalation techniques and it help to correct the frequent errors of inhaler technique.
2. The finding of the study would help the investigator to determine the best teaching on improve the inhaler techniques among OAD patients.
|
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To associate post test level of inhaler technique among the patient with OAD receiving video teaching + Direct teaching with their demographic variables
•To associated post test level of inhaler techniques among the patient with OAD receiving direct demonstration + pamphlet with their demographic variables
|
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="147"
Sample Size from India="147"
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)
|
01/12/2024 |
| 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="1"
Months="0"
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
|
This research study, to be conducted at the Pulmonary Medicine Department, AIIMS Bibinagar, will evaluate the effectiveness of two educational methods for improving inhalation techniques among patients with obstructive airway diseases (OAD). The study will use a true experimental, pretest-posttest design with 147 participants, who will be randomly assigned to one of two groups through block randomization. Interventions: - Group 1 will receive video-based instruction combined with direct demonstration.
- Group 2 will receive direct demonstration supplemented by a pamphlet.
To prevent bias, group allocation will be concealed, and reminders will be sent via WhatsApp to both groups. Each participant will undergo a pretest and a follow-up posttest one month later, using a structured inhaler technique checklist to assess improvement. Data will be statistically analyzed to compare the effectiveness of these teaching methods. The study aims to identify the best approach for improving inhaler use techniques, potentially providing evidence-based guidance for nurses in clinical settings. This could reduce common errors in inhaler use among OAD patients, thereby enhancing patient outcomes. |