Exploring the pharmacist's intervention for precluding the factors effecting medication adherence in Chronic Obstructive Pulmonary Diseases (COPD) following GOLD (Global Initiative for Chronic Obstructive Lungs diseases) guidelines in Pakistan
The aim of the study is to preclude the medication non-adherence in the COPD patients in Pakistan
Design
Study design: A single centered randomized controlled trial
Study Groups: Interventional group, Controlled group
sample size: 144 individuals (72 in each group)
Settings and conduct
The ongoing study is conducted by the the principle investigator in Holy family hospital, Rawalpindi, Pakistan
Participants/Inclusion and exclusion criteria
Inclusion criteria: COPD patients
Exclusion criteria: patients suffering from all other diseases except COPD
Intervention groups
Single interventional group: The main reason for medication non-adherence is unawareness of the disease, medication, treatment and management of the disease. Education intervention is provided to the patients to improve medication adherence
Main outcome variables
Improved medication adherence in COPD patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054875N1
Registration date:2022-05-23, 1401/03/02
Registration timing:prospective
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Hafsa Kanwal
Name of organization / entity
Quaid-i-Azam university, Islamabad
Country
Pakistan
Phone
+92 51 90644128
Email address
hkanwal@bs.qau.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2022-11-01, 1401/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the pharmacist's intervention for precluding the factors effecting medication adherence in Chronic Obstructive Pulmonary Diseases (COPD) following GOLD (Global Initiative for Chronic Obstructive Lungs diseases) guidelines in Pakistan
Public title
The role of pharmacist for enhancing medication adherence in COPD (Chronic Obstructive Pulmonary Diseases) patients in pakistan
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients only attend the outpatient COPD wards, confirmed diagnosis of COPD by the hospital consultant for at least 1 year
Newly diagnosed patients with a forced expiratory volume in 1 s (FEV1) of 30–80% of the predicted normal value
Patients that hospital consultant agree that the patient is suitable for entering the trial
Exclusion criteria:
Moderate to severe learning difficulties
Mobility problems, confusion, disorientation or terminal illness
Congestive heart failure or if they are attending a pulmonary rehabilitation programs consulting a pulmonary nurse or clinical pharmacist in the last 6 months
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Individual patient enrolled in the study as 1:1 is included in Interventional Group and Control Group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rawalpindi Medical University, Rawalpindi, Pakistan
The medication adherence by pharmacist intervention will be improved
Timepoint
Before intervention, after 24 weeks of intervention
Method of measurement
Self-structured medication adherence Questionnaire will be filled to check the adherence level
Secondary outcomes
1
Description
Assessment of patient quality of life by St. George Respiratory Questionnare
Timepoint
Before intervention and after 24 weeks of intervention
Method of measurement
Patients interviews
Intervention groups
1
Description
Intervention group:
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Holy Family Hospital
Full name of responsible person
Prof. Dr. Muhammad Khurram
Street address
J329+WJ2, Tipu Rd, Chamanzar Colony
City
Rawalpindi
Postal code
46000
Phone
+92 51 9290755
Email
drmuhammadkhurram@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Quaid-i-Azam University , Islamabad
Full name of responsible person
Dr. Amjad Khan
Street address
department of pharmacy, Quaid-i-Azam university, Islamabad, Pakistan
City
Islamabad
Postal code
15320
Phone
+92 51 90644128
Email
amjadkhan@qau.edu.pk
Web page address
Grant name
Higher Education commission, Pakistan
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
HEC, indigenous scholarship
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Quaid-i-Azam university, islamabad
Full name of responsible person
Dr. Amjad Khan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of pharmacy, Quaid-i-azam university
City
Islamabad
Province
Capital territory
Postal code
15320
Phone
+92 51 90644128
Email
amjadkhad@qua.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Quaid-i-Azam university, Islamabad
Full name of responsible person
Hafsa Kanwal
Position
Ph. D scholar
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
department of pharmacy, Quaid-i-Azam university, islamabad, Pakistan
City
Islamabad
Province
capital territory
Postal code
15320
Phone
+92 51 90644128
Email
hkanwal@bs.qau.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Quaid-i-Azam university, Islamabad
Full name of responsible person
Hafsa Kanwal
Position
PhD scholar
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
P4XX+HMR, Islamabad, Islamabad Capital Territory
City
Islamabad
Province
Punjab
Postal code
15320
Phone
+92 51 90644128
Fax
Email
hkanwal@bs.qau.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data will be available after publication. And data will be displayed after statistical analysis so there is no need to display individual patient data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study patients demographics, results( primary outcomes, secondary outcomes) will be shared after once the data will be published
When the data will become available and for how long
After publishing data will be available for long
To whom data/document is available
Any researcher or healthcare team member from hospital or academia can ask for the data
Under which criteria data/document could be used
if someone is designing their own study or conducting this type of study
From where data/document is obtainable
e-mail ID = hkanwal@bs.qau.edu.pk
What processes are involved for a request to access data/document
requesting via email, and the data will be provided by the principle investigator
Comments
yes, the study is ongoing conducted but after reading your policy, I can start my study according to the plan after approval