Home » Trials » SLCTR/2024/028
Efficacy of a clinical pharmacy service in the control of hypertension among a cohort of Sri Lankans
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SLCTR Registration Number
SLCTR/2024/028
Date of Registration
The date of last modification
Jan 08, 2025
Scientific Title of Trial
Efficacy of a clinical pharmacy service in the control of hypertension among a cohort of Sri Lankans
Public Title of Trial
Comparison of the efficacy of a clinical pharmacy service vs usual care in reduction of blood pressure in Sri Lankans with hypertension.
Disease or Health Condition(s) Studied
Hypertension
Scientific Acronym
Public Acronym
Brief title
Universal Trial Number
U1111-1307-4667
Any other number(s) assigned to the trial and issuing authority
P/36/03/2024 (Faculty of Medicine, Kelaniya))
What is the research question being addressed?
Can a clinical pharmacy service added to usual care improve blood pressure control compared to usual care alone in a cohort of Sri Lankans?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Other
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Study setting(s) – Ragama Health study (RHS) Clinic, Faculty of Medicine, Ragama.
Consecutive males and females with hypertension attending RHS clinic will be given a research ID stratified by sex and this will be indicated on the first page of the clinic book. Patients will be randomly assigned to intervention and control groups stratified by sex using the study ID. All patients with a study ID consisting of an “even number ‘ will receive intervention while the ones with an ID consisting of an “odd number “ will not receive the intervention.
Intervention arm will receive advise by a clinical pharmacist in addition to usual care.
Control arm will receive – usual care where the doctor will measure blood pressure and prescribe medicine and the hospital pharmacist will dispense medicine according to prescription.
The intervention group will receive standard care together with “Clinical pharmacy intervention” at each clinic visit until 12 months from the recruitment. Routine clinic visits will be scheduled every 2 months according to the hospital policy unless the treating physician decides to see the patient earlier than routine.
The intervention includes:
1. Best possible medication history taking
2. Medicines reconciliation combining previous prescriptions and current prescriptions
3. Medication Order verification and correction after discussing with the physician if any errors of prescription noticed to prevent medication errors.
e.g: dose and dosing schedule, any interactions, deviations from the national BP guidelines
4. Individualized patient counseling on prescription:
indication, direction of use, adverse drug reactions, interactions, storage of drugs, importance of compliance.
Inclusion criteria
All consecutive, consenting male and female patients aged 40 years or older with hypertension who attend the Ragama Health Study clinic of Faculty of Medicine, Ragama, Sri Lanka.
Exclusion criteria
Primary outcome(s)
1.
Difference in the mean systolic BP and diastolic BP reduction in intervention and control groups |
[ Baseline and 12 months. ] |
2.
The percentage with controlled blood pressure between the two groups (SBP≤140 mmHg and DBP≤90 mmHg is defined as having a controlled blood pressure). |
[ 0 (baseline),6 months and 12 months. ] |
Secondary outcome(s)
1.
Analyze patient compliance with prescribed medications facilitated by clinical pharmacy services in the long-term management of blood pressure. Patient compliance will be assessed through the Morisky-Green test questionnaire and pill count. |
[ At 0, 6, 12 months. ] |
2.
Explore patient satisfaction and experiences with clinical pharmacy service in managing blood pressure. Patient satisfaction will be assessed through patients’ satisfaction questionnaire (PSQ) |
[ At 0, 6, 12 months ] |
3.
The difference in the incidence of new cardiovascular events (myocardial infarction, stroke, critical limb ischemic) between the two groups. |
[ At the end of 12 months ] |
Target number/sample size
sample size will be 510 and each arm will consist of 255 patients
Countries of recruitment
Sri Lanka
Anticipated start date
2024-08-31
Anticipated end date
2025-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
None
Status
Approved
Date of Approval
2024-05-14
Approval number
P/36/03/2024
Details of Ethics Review Committee
Name: | Ethics review committee, Faculty of Medicine, University of Kelaniya. |
Institutional Address: | Ethics review committee, Faculty of Medicine, University of Kelaniya. |
Telephone: | 0112961267 |
Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Chamila Mettananda
Professor in Pharmacology
Department of Pharmacology,
Faculty of Medicine, University of Kelaniya,
PO Box 06, Thalagolla Road,
Ragama
0714816310
chamilametta@hotmail.com
Contact Person for Public Queries
Prof. Chamila Mettananda
Professor in Pharmacology
Department of Pharmacology,
Faculty of Medicine, University of Kelaniya,
PO Box 06, Thalagolla Road,
Ragama
0714816310
chamilametta@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results