Plain English Summary
Background and study aims
Type 2 diabetes mellitus (T2DM) occurs when the body is not able to control blood glucose (sugar) levels by producing enough insulin. The rates of T2DM are increasing rapidly with increased burden of related complications and high death rate in Pakistan. T2DM is considered as a major risk factor for heart diseases. Several studies have established that T2DM can be responsive to different interventions, pharmacological (using medications) and non-pharmacological, aimed at improving blood glucose control. Recent guidelines have recommend comprehensive, patient centered diabetes management plans to be undertaken by integrating healthcare providing team including physicians, nurses, pharmacists, dieticians and mental health professionals in a chronic care model.
The aim of this study is to evaluate the effectiveness of pharmacist’s interventions in diabetes management as part of health care providing team in primary health care setting of Lahore, Pakistan by implementing patient centered approach in individualized pharmaceutical care planning including both pharmacological and non-pharmacological aspects.
Who can participate?
Adults aged 18 and older who have T2DM
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive their routine treatment from their physician. Those in the second group receive their routine treatment from their physician and are asked to see pharmacist every four weeks and follow the instructions given for their needs related to their diabetes management. Participants are followed up at three, six and nine months to provide blood and urine samples.
What are the possible benefits and risks of participating?
Participants may benefit from routine medical examinations (as this is often missed due to the costs) and from regular interactions with a pharmacist to support them in their treatment goals. There are no risks associated with participants as all the pharmacists support is based on current guidelines on diabetes management and in collaboration with registered physicians.
Where is the study run from?
Murad Clinic (Pakistan)
When is the study starting and how long is it expected to run for?
October 2015 to June 2017
Who is funding the study?
Investigator initiated and funded (Pakistan)
Who is the main contact?
Dr Hamid Saeed
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hamid Saeed
ORCID ID
http://orcid.org/0000-0002-1400-4825
Contact details
University College of Pharmacy
University of the Punjab
Allama Iqbal Campus
Lahore
540000
Pakistan
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HEC/1000/UCP1926
Study information
Scientific title
Study on A1c Management by Pharmacist in Lahore: A randomised controlled trial to assess the effectiveness of interventions by pharmacist in management of type 2 diabetes mellitus in collaboration with physician
Acronym
SAMPLe Trial
Study hypothesis
Type 2 diabetes mellitus can be better managed when a structured pharmaceutical care plan is implemented by pharmacist.
Ethics approval
Human Ethical Committee Punjab University College of Pharmacy University of the Punjab, 18/03/2016, ref: HEC/1000/UCP 1926
Study design
Interventional single-centre longitudinal randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Type 2 Diabetes Mellitus
Intervention
The participants of this study are randomised according to individual patient's enrollment number i.e. the odd numbers were allocated to control arm and even numbers to intervention arm.
Participants in control arm receive their routine treatment from their physician.
Participants in intervention arm receive their routine treatment from their physician and they were asked to see pharmacist every four week and follow the instructions given for their needs related to type 2 diabetes mellitus management
Routine medical examination of all participants in both arms is performed at baseline, three, six and nine months by taking blood and urine samples.
Participants are followed up after every three months for a total treatment duration of nine months. They are tests for their glycated haemoglobin, lipid profile, and blood pressure.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
1. Glycated Haemoglobin (HbA1c) is measured using the laboratory results from blood samples at baseline and three, six and nine months
2. Lipid profile is measured using laboratory results from blood samples at baseline, three, six, and nine months
3. Blood pressure is measured using the mercuric sphygmomanometer at baseline, three, six and nine months for both control and intervention arm patients and at every visit i.e. 4 weeks for intervention arm patients
Secondary outcome measures
1. Height (m) is measured using a height rod at baseline, three, six and nine months
2. Weight (Kg) is measured using weighing balance at baseline, three, six and nine months
3. Waist (cm) is measured using measuring tape at baseline, three, six and nine months
4. Serum Creatinine (mg/dL) is measured using blood samples at baseline, three, six and nine months
5. Estimated Glomerular Filtration Rate (eGFR) is measured using Modification of Diet in Renal Disease (MDRD) Equation at baseline, three, six and nine months
6. Heamatology Report is measured using blood samples at baseline, three, six and nine months
7. Complete Urine Examination is measured using urine sample at baseline and six months
8. Foot Examination is measured using micro-monofilament and tunning fork at baseline, three, six and nine months
Overall trial start date
24/10/2015
Overall trial end date
03/06/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Either Male / Female
2. Resident of Lahore City
3. Age ˃18 Years
4. Haemoglobin ˃13mg/dL
5. Type 2 Diabetes Mellitus
6. Glycated Heamoglobin (HbA1c) ˃8% i.e. poorly controlled
7. With or Without Hypertension (HTN)
8. With or Without Diabetic Nephropathy
9. With or Without Hepatosteatosis (Fatty Liver)
10. Without Psychosis and Cognitive Disorder
11. With or without Insulin use
12. No Pharmacist Involvement in Diabetes Management
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350 Type 2 Diabetes Mellitus Patients
Participant exclusion criteria
1. The patients with any other type of diabetes mellitus
2. Patients with Glycated Heamoglobin (HbA1c) ˂ 8%
3. Patients below age 18 years and above 70 years
4. Patients who refused to sign the consent form
5. Patients who showed no interest for future visit to study site and or participant physicians
6. Patient with cognitive and or psychotic disorders
7. Hospitalised Patients
Recruitment start date
20/03/2016
Recruitment end date
20/08/2016
Locations
Countries of recruitment
Pakistan
Trial participating centre
Murad Clinic
Private Healthcare Establishment with Punjab Healthcare Commission (Reg. No-R-28152)
23/2 Shalimar Link Road, near Shalamar Hospital
Mughalpura
Lahore
54000
Pakistan
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. Study design, statistical analysis and even questionnaire will be available soon after publication and end 36 months following publication
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/01/2018
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary