| CTRI Number |
CTRI/2025/09/095278 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pharmaceutical care ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Health and Quality of Life in People with COPD: The Role of Pharmacist-Led Education and Guideline-Based Care |
|
Scientific Title of Study
|
Impact of pharmacist-led guideline based patient care on clinical and humanistic outcomes in chronic obstructive pulmonary disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milagrin Xavier |
| Designation |
PhD Research Scholar |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, NGSM Institute of Pharmaceutical Sciences,Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8848366787 |
| Fax |
|
| Email |
milagrinxavier98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate professor and Head |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, NGSM Institute of Pharmaceutical Sciences,Deralakatte, Mangaluru, 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milagrin Xavier |
| Designation |
PhD Research Scholar |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, MGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru, 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8848366787 |
| Fax |
|
| Email |
milagrinxavier98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nitte University |
| Address |
6th Floor, University Enclave, Medical Sciences complex, Deralakatte,Mangaluru, Karnataka,575018 |
| 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 |
| Dr Milagrin Xavier |
Justice KS Hegde Hospital |
Department of Pulmonology,Justice KS Hegde Charitable Hospital, Nitte(Deemed to be Unioversity), Deralakatte, Mangaluru, Karnataka,India
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
8848366787
milagrinxavier98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Nitte University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control grouo0 |
The study consists of COPD patients. They will receive only the usual standard care as per guidelines from the pulmonologist and nurses. Each patient is required to be monitored 4 times i.e. baseline, 4th, 8th and 12th month after enrolling the study. |
| Intervention |
Interventional study- Randomized control study |
The study consists of COPD patients. Each patient is required to be monitored 4 times i.e. baseline, 4th, 8th and 12th month after enrolling the study. They will receive pharmaceutical care along with standard care delivered by the principal investigator. The pharmaceutical care consists of education through validated booklet and health education video, continuous monitoring and evaluating their respiratory function like FEV ,6MWT, SpO2 and biochemical parameters like eosinophils, ESR AND RBS, symptom assessment using CAT and mMRC Dyspnea scale, medication adherence using Morisky and Green-Levine (MGL) and quality of life using St. George Respiratory Questionnaire (SGRQ). The education is provided to the patient or caretaker during baseline visit with the help of booklet and video which contains information regarding disease, drugs, lifestyle modification, inhaler techniques. This group will be monitored and assessed during study period by reminding them every month through phone calls and reminder messages will be given for taking medications and doing advised physical exercises. At the 12th month along with all the above-mentioned parameters patient satisfaction using self-developed questionnaire, cost of illness including both direct and indirect cost and severity assessment using BODE criteria will also be analyzed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients either gender who are diagnosed with COPD and willing to provide the
informed consent |
|
| ExclusionCriteria |
| Details |
a) Patients with other respiratory tract infections
b) Patients with cancer, end-stage renal disease, heart failure
c) Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of pharmaceutical care in improving clinical and humanistic outcomes in COPD patients |
0 4 8 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes: Measurement of medication adherence, p0atient satisfaction, cost of illness and severity assessment. |
0 4 8 12 months |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
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)
|
03/10/2025 |
| 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="2"
Months="0"
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
|
• Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by persistent obstruction of airflow through the lungs and associated symptoms. The number of global prevalent cases of COPD increased from 100.54 million in 1990 to 213.39 million in 2021. And in India, it is estimated at approximately 7.4%. It is one of the top three causes of death worldwide and 90% of this death occurs in low- and middle-income countries. The Global Initiative for Obstruction and Prevention of Lung Disease (GOLD) is the standard guideline for diagnosis, management and prevention of COPD. In India, the provision of pharmaceutical care lacks in many of the pulmonary clinics, leading to suboptimal medication management, poor disease control and clinical outcomes’ patients require a long term follow up by healthcare professional for their wellbeing. Despite major advances in the medical care, COPD treatment is still challenging due to lack of personalized patient care, regular monitoring and follow up. With this background, the proposed study aims to provide a guideline-based service through pharmacist-led care, with continuous monitoring and follow-up, to assess its impact on clinical and humanistic outcomes |