Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2017
Date assigned
16/05/2017
Last edited
15/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. About 415 million people suffered from diabetes in 2014 and it is expected that this will increase to 642 million by 2040. In Pakistan, about 6.9% of the adults suffered from diabetes in 2015 and it is estimated that this will increase up to 8.2% by 2040. Presently, in Pakistan, most people visit public and private sector hospitals for the management and treatment of diabetes, but since the doctors are extremely overburdened in most healthcare settings, they cannot give ample consultation time to the patients. In Pakistan, one doctor caters to the healthcare needs of almost 1073 patients, which represents a very low doctor to patient ratio. The problem can be dealt effectively if community pharmacists play a role in controlling and managing diabetes. Community pharmacists have ample medical knowledge and can provide both the appropriate information as well as sufficient time for controlling and managing diabetes. To date, very few studies from Pakistan have explored the role of pharmacists in diabetes management, specifically in community pharmacies. The aim of this study is to assess the impact of pharmacist-led interventions on blood sugar control and patient satisfaction in diabetes management at a community pharmacy.

Who can participate?
Patients aged 18-70 with type 2 diabetes

What does the study involve?
Participants are randomly allocated to either the control or the experimental group. The control group receive routine medications and diet plan. The experimental group receive interventions about self-management, quality of life, medication adherence, blood sugar control and knowledge about the disease. Information is provided through a diet chart, a foot care chart, and a low and high blood sugar chart, and the importance of exercise and medication by conversation with the participants. All participants are followed up 1 month later to check their blood sugar and their satisfaction with the services provided during this study.

What are the possible benefits and risks of participating?
The study may help the patient to control and manage their diabetes. There are no direct risks associated with participating in this study.

Where is the study run from?
Well Plus Community Pharmacy (Pakistan)

When is the study starting and how long is it expected to run for?
December 2016 to August 2017

Who is funding the study?
Investigator initiated and funded (Pakistan)

Who is the main contact?
Mr Muhammad Abubakar

Trial website

Contact information

Type

Scientific

Primary contact

Mr Muhammad Abubakar

ORCID ID

http://orcid.org/0000-0003-4129-1572

Contact details

Khawaja Farid campus
Railway Rd
Bahawalpur
63100
Pakistan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Patient satisfaction with pharmacist-led interventions in diabetes management at a community pharmacy: a randomised controlled trial

Acronym

Study hypothesis

Pharmacist-led interventions have a positive impact on diabetes-related knowledge of patient, perception of self-management of the disease, quality of life of patient, medication adherence, glycemic control and patient satisfaction about the services provided at community pharmacy during the trial.

Ethics approval

Pharmacy and Research Ethics Committee (PREC) at the Department of Pharmacy, the Islamia University of Bahawalpur, 22/12/2016, ref: 43-2016/PREC

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Type 2 diabetes mellitus

Intervention

Simple random sampling was used for the participants. There are different intervention strategies for the control and the experimental group:
1. The control group received routine medications and dietary plan and no intervention was applied.
2. The experimental group received interventions about self-management, quality of life, medication adherence, glycemic control and knowledge about the disease. Intervention related information was provided through a diet chart, a foot care chart, and a hypo- and hyper-glycemic chart, and the importance of exercise and medication by verbal conversation with the participants.

The total duration of intervention and follow-up was up to 1 month from the date of registration into the trial.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Glycemic control, measured using the strip method Accu check performa meter at baseline and after the completion of 1 month of intervention
2. Patient satisfaction about the services provided during trial, measured using the DDSM-Q after the completion of 1 month of intervention

Secondary outcome measures

1. Perception of self-management of diabetes, measured using the DDSM-Q
2. Disease state knowledge, measured using the DDSM-Q
3. Quality of life, measured using the EQ-5D-3L
4. Medication adherence, measured using the MMAS
Measured at baseline and after completion of 1 month of intervention

Overall trial start date

01/12/2016

Overall trial end date

30/08/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with type 2 diabetes mellitus (T2DM) diagnosed by a registered medical practitioner
2. Minimum one year T2DM history
3. Age 18-70 years
4. On anti-diabetes therapy
5. Co-morbidity may or may not be present
6. Minimum two follow-up visits within one month period from the date of registration in trial
7. Both male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Type 1 diabetes
2. Diabetes insipidus
3. Gestational diabetes and other forms of diabetes
4. Age <18 and >70
5. Not on anti-diabetic therapy
6. Less than two follow-up visits within one month period from the date of registration in trial

Recruitment start date

01/12/2016

Recruitment end date

30/05/2017

Locations

Countries of recruitment

Pakistan

Trial participating centre

Well Plus Community Pharmacy
Rafi Qamar road, One unit chowk
Bahawalpur
63100
Pakistan

Sponsor information

Organisation

The Islamia University of Bahawalpur

Sponsor details

Khawaja Farid campus
Railway Rd
Bahawalpur
63100
Pakistan

Sponsor type

University/education

Website

http://www.iub.edu.pk

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings will be published in a high impact journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Muhammad Abubakar.

Intention to publish date

01/09/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes