Impact of medication therapy management programme on diabetes healthcare outcomes in a community pharmacy setting
| ISRCTN | ISRCTN60703981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60703981 |
- Submission date
- 02/12/2022
- Registration date
- 09/12/2022
- Last edited
- 13/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Community pharmacies (CPs) are at the heart of communities because they are the most accessible healthcare settings with a large number of people using their services. As a result, community pharmacists have emerged as a focal point for the modernization of primary and community care services. Literature demonstrated that expanding the roles of community pharmacists could result in numerous patient-related benefits. This study aims to assess the effectiveness of the community pharmacy-based Medication Therapy Management programme compared with standard care in improving patient healthcare outcomes of patients with uncontrolled diabetes.
Who can participate?
Adult patients with uncontrolled diabetes mellitus
What does the study involve?
In this study, we are trying to establish if community pharmacy-based medication reviews can improve diabetes management among patients with uncontrolled diabetes. Patients with uncontrolled diabetes received either systematic medication review or standard care in the community pharmacy and follow-up for a minimum of 6 months.
What are the possible benefits and risks of participating?
Depending on your group allocation, you can have your medication therapy reviewed by an expert pharmacist. This may help you in controlling your diabetes. In the future, this study could help enhance the Saudi health system by introducing a new service offered by community pharmacists. We do not anticipate any disadvantages to participants taking part. You will need to give your time to participate in the study including completing questionnaires and attending follow-up appointments.
However, participation is voluntary, and patients can withdraw from the study at any stage without giving any reason and without any negative consequences on the care provided by the health professionals.
Where is the study run from?
Princess Nourah bent Abdulrahman University (KSA) and the University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
April 2021 to June 2022
Who is funding the study?
No specific funding has been obtained to undertake this trial. However, the lead researcher, Basmah Albabtain is funded by Princess Nourah bent Abdulrahman University (KSA) to undertake her PhD degree at the University of Birmingham
Who is the main contact?
Basmah Albabtain (principal researcher, PhD student), baa985@student.bham.ac.uk
Contact information
Principal Investigator
Lecturer in Pharmaceutical Practice
Department of Pharmaceutical Practice
Princess Nourah bint Abdulrahman university compound
Riyadh
1234
Saudi Arabia
 ORCID ID |
0000-0001-6467-263X |
|---|---|
| Phone | +966504335566 |
| basmah.albabtain@outlook.com |
Scientific
Lecturer in Pharmaceutical Practice
Department of Pharmaceutical Practice
Princess Nourah bint Abdulrahman university compound
Riyadh
1234
Saudi Arabia
| Phone | +966504335566 |
|---|---|
| baa985@student.bham.ac.uk |
Study information
| Study design | Randomized control study set up as a 2-arm open-label parallel-group investigation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Impact of medication therapy management programme on diabetes healthcare outcomes in a community pharmacy setting: a randomised controlled study |
| Study objectives | The community pharmacy-based medication therapy management (MTM) programme is effective compared to standard care in improving diabetic patient healthcare outcomes. |
| Ethics approval(s) | 1. Approved 13/07/2020, Ethical Review Board of Princess Nourah bent Abdulrahman University (Riyadh, Kingdom of Saudi Arabia, 11671, PO Box 84428; +966548867916; irb@pnu.edu.sa), ref: 20-0240 2. Approved 15/07/2020, King Fahad Medical City (Riyadh, Kingdom of Saudi Arabia, 11525 PO Box 59046; +96612889999 ext. 26943; InstitutionalReviewBoard@kfmc.med.sa), ref: 20-388E 3. Approved 11/01/2021, Birmingham University (Edgbaston, B15 2TT, UK; +44 (0)1214148101; s.m.waldron@bham.ac.uk), ref: ERN_20-0768 |
| Health condition(s) or problem(s) studied | Medication therapy management for chronic disease patients with uncontrolled diabetes |
| Intervention | The study involves an intervention group comprising a community pharmacy-based medication therapy management (MTM) programme for a minimum of 6 months and a control group of standard care in community pharmacy practices. Randomization was provided by an independent person not otherwise involved in the study. Consenting participants were randomized in a 1:1 ratio to either MTM services or standard care. Recruitment was conducted until the required number of participants was enrolled. An allocation sequence was based on a computer-generated (Excel sheet) list of random numbers and sequentially numbered tamper-proof opaque sealed envelopes were used to conceal sequence allocation. |
| Intervention type | Other |
| Primary outcome measure | Hemoglobin A1C (HbA1C) levels measured using a blood test at baseline, 3 and 6 months |
| Secondary outcome measures | 1. Clinical parameters measured using blood test at baseline, 3 and 6 months: 1.1. Blood pressure (BP) (mmHg) (systolic BP and diastolic BP) 1.2. Lipid profile (mg/dl) (low-density lipoprotein [LDL], total cholesterol [TC], triglyceride [TG]) 1.3. Albumin-to-creatinine ratio (ACR) (mg/g) and serum creatinine (sCr) (mg/dl) 2. Description of MTM programme measured using chi-square tests and reported as no. and % using Stata/SE 17 at baseline, 3 and 6 months: 2.1. Number of patient visits 2.2. Number and type of referrals 2.3. Pharmacist consultation time per participant (minutes) 3. Number and types of drug-related problems (DRPs): 3.1. DRPs that need an additional drug 3.2. Supply drugs without indication 3.3. Adverse drug reaction 3.4 Ineffective drug 3.5. High/low dose 3.6. Noncompliance 4. Health services utilization including the number and reasons for hospitalization or ED during the study period measured using the Firth-type logistic regression and reported as no. and % using Stata/SE 17 at baseline, 3 and 6 months 5. Patient medication adherence measured using the Medication Adherence Report Scale-5 (MARS-5) at baseline and 6 months 6. Diabetes distress measured using the Diabetes Distress Scale (DDS) at baseline and 6 months 7. Patient satisfaction with pharmacist services using The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2. 0) at 6 months |
| Overall study start date | 13/04/2021 |
| Completion date | 21/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 patients, 80 in each arm |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. Uncontrolled diabetes (defined as having glycated haemoglobin blood (HbA1c) ≥ 8%) 2. Age 18 years and over 3. Able to provide informed consent 4. Have a continuous active status with the medical center (defined as having a record of at least 1 visit in the 6 months before screening) 5. Speak either Arabic or English |
| Key exclusion criteria | 1. Severe mental illness or dementia or significant cognitive impairment 2. Gestational diabetes 3. Unstable acute complications/illness |
| Date of first enrolment | 13/04/2021 |
| Date of final enrolment | 08/09/2021 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
14254 alfayha
Saudi Arabia
Sponsor information
University/education
Airport Road
King Khalid International Airport
P.O.Box 84428
Ryadh
11671
Saudi Arabia
| Phone | +966 0118220000 |
|---|---|
| info@pnu.edu.sa | |
| Website | http://www.pnu.edu.sa/en |
"ROR" |
https://ror.org/05b0cyh02 |
University/education
Edgbaston Campus
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| pharmacyenquiries@contacts.bham.ac.uk | |
| Website | https://www.birmingham.ac.uk |
|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Princess Nora University, Princess Nora Bint Abdulrahman University, PNU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. Findings will also be presented at national and international conferences. 3. Since this is part of a PhD research project, the electronic version of the thesis will be deposited in the University of Birmingham e-repository. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request after 1 year of completion of the study and publication of the first manuscript. Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed on a case-by-case basis by the trial coordination committee in discussion with the clinical investigators (CIs). Please contact Basmah Albabtain (basmah.albabtain@outlook.com). These data will also be added to the University of Birmingham e-repository after the successful defence of a PhD thesis. Please note that the link for the e-repository will be shared once data is deposited. The type of data that will be shared: All requested data. Whether consent from participants was required and obtained: Yes, a consent form was required and obtained from all participants before the randomization. Comments on data anonymization: Anonymity was preserved by removing identifiable data and assigning all participants a unique study identification number. Furthermore, data that can be linked to a particular individual were fully anonymized before publishing, or not published at all. We followed ethical and legal practice and all information were handled in confidence. All data obtained were anonymized and kept on a password-protected personal computer. Only the research staff had access to those data. Any ethical or legal restrictions: No. Any additional comments: None. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/05/2021 | 08/12/2022 | Yes | No |
| Results article | 01/08/2024 | 13/02/2025 | Yes | No |
Editorial Notes
13/02/2025: Publication reference added.
08/12/2022: Trial's existence confirmed by the Ethical Review Board of Princess Nourah Bent Abdulrahman University.
