| CTRI Number |
CTRI/2025/12/098283 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Impact of a Self-Management Intervention on Quality of Life of adults with chronic lung disease attending primary health centres in Ballabgarh, Haryana |
|
Scientific Title of Study
|
Effectiveness of a Structured Self-Management Intervention on Health-Related Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD) delivered in Primary Care Settings at Ballabgarh, Haryana: A quasi-experimental pragmatic trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palak Choudhary |
| Designation |
Junior Resident (MD Student) |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 14, Centre for Community Medicine, Old OT Block, AIIMS New Delhi
South DELHI 110029 India |
| Phone |
09024846815 |
| Fax |
|
| Email |
drpalak999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harshal Ramesh Salve |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 40, Centre for Community Medicine, Old OT Block, AIIMS New Delhi
South DELHI 110029 India |
| Phone |
9911253846 |
| Fax |
|
| Email |
harshalsalve@ymail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Harshal Ramesh Salve |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 40, Centre for Community Medicine, Old OT Block, AIIMS New Delhi
South DELHI 110029 India |
| Phone |
9911253846 |
| Fax |
|
| Email |
harshalsalve@ymail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Palak Choudhary |
PHC Chhainsa |
Room 03 Ground Floor PHC Chhainsa Ballabgarh Faridabad Pin code 121004
Faridabad
HARYANA Faridabad HARYANA |
09024846815
drpalak999@gmail.com |
| Dr Palak Choudhary |
PHC Dayalpur |
Room 04 Ground floor PHC Dayalpur Ballabgarh Faridabad Pin code 121004 Faridabad HARYANA |
09024846815
drpalak999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee All India Institute of Medical Sciences Room No. 102 1st Floor Old OT Block Ansari Nagar New Delhi |
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 |
| Comparator Agent |
COPD Treatment as per current PHC practices |
Treatment as per current PHC practices |
| Intervention |
Structured Self Management |
Face to Face sessions of around 40 minutes on Recognition of COPD exacerbation, Compliance to medication, Appropriate inhaler use technique, Lifestyle modification, Stress coping practices, Reduce air pollution exposure, Counsel for vaccination and health diary, flyer and monthly home visit by health worker for reinforcement over next 9 months. All the participants would be recruited over 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult COPD patients confirmed by spirometry as per
GOLD 2025 (post-bronchodilator FEV1/FVC less than 0.70)
|
|
| ExclusionCriteria |
| Details |
Contraindications for spirometry (eg.
decompensated heart failure, active TB, malignancy, haemoptysis of unknown origin, pneumothorax, recent MI or pulmonary embolus, recent eye surgery, recent thoracic or abdominal surgery) as reported by the patients,
Critically ill patients,
Patients who do not have functional phone in the household
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health-related Quality of Life measured using St George Respiratory Questionnaire |
Baseline and endline (9 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FEV1 % predicted via spirometry |
Baseline and endline (9 months) |
| Healthcare utilization |
At 3,6 & 9 months |
| Frequency of acute exacerbations of COPD |
At 3,6 & 9 months |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
10/12/2025 |
| 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="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a quasi-experimental pragmatic trial to be
conducted at two Primary Health Centres (Chhainsa and Dayalpur) in the
Ballabgarh field practice area of AIIMS, New Delhi. The study will include 80
adult patients with spirometry-confirmed COPD, with 40 participants enrolled
at each PHC. One PHC will serve as the intervention site, where a structured
self-management package will be delivered in addition to routine care, while
the other PHC will serve as the control site, where patients will continue to
receive treatment as per current practices. The structured intervention will
be delivered through face-to-face counselling sessions at baseline by the
investigator and pharmacist, supported by a health diary and educational
flyer. Monthly reinforcement visits will then be carried out at the
participants’ homes by trained health workers for 9 months. The intervention
includes counselling on recognition of exacerbations, medication adherence,
correct inhaler technique, lifestyle modification (smoking cessation, nutrition,
physical activity), stress management (breathing techniques and yoga),
vaccination counselling, and reduction of air pollution exposure. Baseline assessment will include sociodemographic details,
spirometry (FEV1 percent predicted), and health-related quality of life
measured using the St. George’s Respiratory Questionnaire (SGRQ). Follow-up
will consist of telephonic interviews at 3 and 6 months, and an endline
assessment at 9 months. The primary outcome is change in SGRQ score;
secondary outcomes include lung function, frequency of acute exacerbations, and
healthcare utilization.
|
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