Home » Trials » SLCTR/2024/028


Efficacy of a clinical pharmacy service in the control of hypertension among a cohort of Sri Lankans

-

SLCTR Registration Number

SLCTR/2024/028


Date of Registration

29 Aug 2024

The date of last modification

Jan 08, 2025



Application Summary


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))


Trial Details


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

  1. Pregnant or lactating women.
  2. Persons with advanced illness (e.g., those receiving dialysis or with liver failure), terminal illness, or a permanently bedridden individual are too ill to commute to the clinic regularly.
  3. Persons living with psychosocial disabilities for whom instructions have not been adapted.


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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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