Role of pharmacist in diabetes management at community pharmacy
| ISRCTN | ISRCTN10671625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10671625 |
| Secondary identifying numbers | 1 |
- Submission date
- 12/05/2017
- Registration date
- 16/05/2017
- Last edited
- 15/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
Khawaja Farid campus
Railway Rd
Bahawalpur
63100
Pakistan
 ORCID ID |
0000-0003-4129-1572 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Patient satisfaction with pharmacist-led interventions in diabetes management at a community pharmacy: a randomised controlled trial |
| 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(s) | Pharmacy and Research Ethics Committee (PREC) at the Department of Pharmacy, the Islamia University of Bahawalpur, 22/12/2016, ref: 43-2016/PREC |
| 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 |
| 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 study start date | 01/12/2016 |
| Overall study end date | 30/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 200 |
| 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 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
Study participating centre
Bahawalpur
63100
Pakistan
Sponsor information
University/education
Khawaja Farid campus
Railway Rd
Bahawalpur
63100
Pakistan
| Website | http://www.iub.edu.pk |
|---|---|
"ROR" |
https://ror.org/002rc4w13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Findings will be published in a high impact journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Muhammad Abubakar. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/08/2021 | 15/06/2023 | Yes | No |
Editorial Notes
15/06/2023: Publication reference added.
