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SLCTR Registration Number
SLCTR/2014/034
Date of Registration
The date of last modification
Apr 23, 2017
View original TRDS
Scientific Title of Trial
A pharmacist-led program to improve patient management of medications in diabetes in rural and urban outpatient settings in Sri Lanka
Public Title of Trial
The impact of clinical pharmacy services for diabetic outpatients in Sri Lanka
Disease or Health Condition(s) Studied
Diabetes
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Do clinically oriented services of pharmacists improve the drug management by diabetic patients attending hospital outpatient clinics?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded
Control
Standard therapy
Assignment
Parallel
Purpose
Health services research
Study Phase
Intervention(s) planned
Participants will be recruited from the Colombo North Teaching hospital and Dambadeniya Base hospital, Sri Lanka.
Those in the intervention arm will receive verbal counseling on the prescribed drugs (drug name, indication, dose, side effects) as repetitive episodes for 4 consecutive clinic visits
After the physician visit, the patients will be provided with verbal counseling regarding their medicines by a graduate pharmacist. The patient will be sent to the dispensing pharmacist with printed packets including details regarding the drug.
The control group will receive standard clinic care.
Inclusion criteria
Patients who have type 1 and type 2 diabetes at least for three years with or without complications
Exclusion criteria
Patients who cannot speak and understand Sinhala or English and patients who do not consent
Primary outcome(s)
|
1.
Disease control as defined by changes in 1. HbA1c 2.Fasting blood glucose |
[ At four months following recruitment ] |
Secondary outcome(s)
|
1.
Knowledge about drugs and adherence to those using a validated questionnaire |
[ At baseline and at the last day of follow up at the clinic. ] |
Target number/sample size
800
Countries of recruitment
Sri Lanka
Anticipated start date
2014-12-05
Anticipated end date
2015-10-05
Date of first enrollment
Date of study completion
Recruitment status
Complete
Funding source
National Research Council
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
S. F. Jayamanne
Senior Lecturer
Department of Medicine, Faculty of Medicine, Ragama
0112953451
0773014722
shalukajaya@yahoo.com
Contact Person for Public Queries
S. F. Jayamanne
Senior Lecturer
Department of Medicine, Faculty of Medicine, Ragama
0112953451
0773014722
shalukajaya@yahoo.com
Primary study sponsor/organization
National Research Council
380/97, Bauddhaloka Mawatha, Colombo 07
011-2695060
011-2675136
nrc@sltnet.lk
nrc.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
