Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311766174946 Date of Approval: 13/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The outcome of a clinical pharmacist-led diabetes education initiative in type II diabetes mellitus patients
Official scientific title The outcome of a clinical pharmacist-led diabetes education initiative in Sudanese patients with type ii diabetes
Brief summary describing the background and objectives of the trial Most of the studies investigating the role of clinical pharmacists in the management of T2DM were predominantly observational with a considerable degree of heterogeneity. Randomized control trials (RCTs) are the gold standard for assessing the effectiveness of therapeutic interventions. T2DM requires the cooperation of all medical personnel to receive appropriate medical care. Previous studies have shown that this disease affects the patient's life. Little is known about the role of clinical pharmacists in the management of T2DM in developing counties, especially in a country like Sudan, in which clinical pharmacy services are still not well-established in many hospitals. This study aimed to evaluate the outcome of a clinical pharmacist-led diabetes education initiative in Sudanese patients with T2DM
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2020
Actual trial start date 15/01/2020
Anticipated date of last follow up 01/12/2020
Actual Last follow-up date 15/12/2020
Anticipated target sample size (number of participants) 322
Actual target sample size (number of participants) 364
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Primary care physicians per usual standard care management is done by Primary care physicians per usual standard care 12 months Management per standard care included the routine role of physicians and the referrals to ophthalmology, nephrology, cardiology and neurology clinics. 182 Uncontrolled
Experimental Group education 11 educational videos 12 months Twelve educational videos about diabetes over five months were sent to the interventional group by the principal investigator and three other assistant investigators (junior clinical pharmacists). The educational videos were produced by a well-practised clinical pharmacist and covered all information about diabetes mellitus in general, medications use, lifestyle changes, and self-care activities. The intervention was done in the first five months of the data collection. After that, the PMDC visits and sending of the videos were scheduled more frequently during the early months of the interventional period to ensure patient engagement and provide enough opportunities and time to address all patients' goals and concerns. 182
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals with T2DM aged more than 18 years (adult, older adult) of both sexes and attending the outpatient clinic were eligible for the study. Any pregnant patients with diabetes, patients currently using medications (like diabetogenic immunosuppressants or antidepressants) that may affect blood glucose levels at the time of the study any patients who were unable to communicate were excluded from the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 33 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/01/2020 Omdurman Islamic university faculty of pharmacy reseach committee
Ethics Committee Address
Street address City Postal code Country
khartoum khartoum 382 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome changes in Fasting blood glucose, HbA1c levels. Other primary outcome measures included diabetic patients' KAP results, adherence, satisfaction, QoL scores, diabetes-related markers like BMI, LDL, HDL, TC, TG, BP, Scr, and BUN and urine analysis; for the presence of proteinuria. baseline , 6months and 12 months
Secondary Outcome 1. Percentage of patients complying with annual lipid testing 2. Percentage of patients compliant with statin therapy 3. Percentage of patients achieving a blood pressure goal of less than 140/90 at the end of the trial period 4. Percentage of patients compliant with annual retinopathy examination 5. Percentage of patients compliant with annual nephropathy examination 6. Percentage of patients who had proteinuria and were taking a kidney-sparing agent (e.g., angiotensin-converting-enzyme inhibitor, angiotensin-receptor blocker, or calcium channel blocker) by study end. baseline and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Omdurman Military Hospital khatoum khartoum Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
no fund omdurman khartoum Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self sponsored omdurman khartoum Sudan Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator safa badi safaabadi30@gmail.com +249910616330 omdurman
City Postal code Country Position/Affiliation
khartoum Sudan assistant professor of clinical pharmacy omdurman islamic university
Role Name Email Phone Street address
Public Enquiries safaa badi safaabadi30@gmail.com +249910616330 omdurman
City Postal code Country Position/Affiliation
khartoum Sudan assistant professor
Role Name Email Phone Street address
Scientific Enquiries safaa badi safaabadi30@gmail.com +249910616330 omdurman
City Postal code Country Position/Affiliation
khartoum Sudan assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes yes I will share the IPD. IPD will be provided to qualified researchers with an academic interest in diabetes Mellitus within 6 months after publication Informed Consent Form Individual Participant Data will be available 6 months after publication only the principal investigator will decide to give the access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 10/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information