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.: PACTR201909534333056 Date of Approval: 05/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Community Pharmacy-Based Chronic Care of Diabetic Patients in Alexandria Governorate
Official scientific title Community Pharmacy-Based Chronic Care of Diabetic Patients in Alexandria Governorate
Brief summary describing the background and objectives of the trial The proposed study firmly believes in the effectiveness of the CBIs in optimizing the care of chronic diseases. As a proxy of the CBIs, it hypothesizes that empowering the community (private, retail) pharmacies by qualified and adequately trained pharmacists render them cressets that deliver a simplified, convenient, effective and economic guiding care to local diabetic patients efficient enough to upgrade their knowledge, self-efficacy and quality of life. In an attempt to furnish an evidence-based proof for this hypothesis, the proposed study will test the outcomes of a community pharmacy-based intervention for chronic care of diabetic patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 04/10/2017
Actual trial start date 08/03/2018
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date 19/09/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 132
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CBPI get education of diabetes 3 months Training of the intervention group pharmacists to explain the: * Study objectives, procedures, phases and outcomes * DM fact/ follow up sheet * Briefing of the intervention group patients to explain the diabetes factsheet and follow up 50
Control Group UC NO TRAINING 3 MONTHS USAUL CARE 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
T2 DM patients who frequent the selected pharmacies and fulfill the following inclusion criteria: ▪ Age >18 years. ▪ Uncontrolled T2 DM ( HbA1c: 7+% ) ▪ Local resident within the pharmacy catchment area. ▪ Don’t have health insurance. ▪ Interested and willing to participate in the study. ▪ Submit a written consent to take part in the study. adult diabetic patients are excluded if they have: ▪ End stage renal disease and on dialysis. ▪ Decompensated liver disease or heart failure. ▪ Overt diabetes complications (eg, cerebrovascular strokes, lower limb amputation advanced retinopathy/ blindness, …..etc). ▪ Gestational diabetes or breast feeding mothers. ▪ Dementia. ▪ Already enrolled in other diabetes education programs. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 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 13/07/2017 High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
165 El-Horreya Avenue. El-Ibrahimia Alexandria 42425 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Empowerment of community pharmacy-based partnership to enhance the chronic care of diabetes 6 months
Secondary Outcome 1. Designing and implementation of a simple and feasible diabetes care model (DCM) 2. Upgrading the patient knowledge and self-management of diabetes. 3. Improvement of the DCM clinical and economic outcomes and patient quality of life. 4. Decrement of the direct diabetes management cost and sickness duration 5. Sensitization of studied patients to notify individuals at risk of DM, pre-diabetics and diabetics.   7 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mohamed Salem pharmacy Nagee Hafez Alexandria Egypt
Abdel Rhman Hawary pharmacy Amrya Alexandria Egypt
Thanaa Emara pharmacy ElNasrya Alexandria Egypt
Hamdi ElGebaliy pharmacy Cairo Alexandria Road Alexandria Egypt
Momen pharmacy ElNasrya Alexandria Egypt
Akram pharmacy Elnasrya Elgadeda alexandria Egypt
Dr. Sheref pharmacy Cairo Alexandria road Alexandria Egypt
Dr Mohamed waleed pharmcy Elnasrya Alexandria Egypt
Dr Ramadan pharmacy ELnasrya Alexandria Egypt
Dr Ahmed Nawar pharmacy Elgazaer Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrexandria University Algeesh St Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University High Institute of Public health Champlion Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alexandria University Student Hospital Hurryia St Alexandria Egypt
Faculty of pharma Pharos University Somuha Alexandria University Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Magdy Allam m_mohamed0902@alexmed.edu.eg 0201061583727 Ibrahymia
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Endocrinology AUSH Alexandria University
Role Name Email Phone Street address
Public Enquiries Magdy Allam m_mohamed0902@alexmed.edu.eg 0201061583727 Ibrhymia
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Endocrinology AUSH Alexandria University
Role Name Email Phone Street address
Principal Investigator Hassan Mohamed faraghfm@gmail.com 020101356895 horryeiah
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Tropical Health
Role Name Email Phone Street address
Principal Investigator Ramy Ghazy ramyghazy@yahoo.com 0201061583727 Hurrrya
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Lecturer of Tropical Health
Role Name Email Phone Street address
Principal Investigator Magdy Allam m_mohamed0902@alexmed.edu.eg 02011996680 Champlion
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Endocrinology
Role Name Email Phone Street address
Principal Investigator Rania Emara ranaemara@gmail.com 02010000020 Hurrya
City Postal code Country Position/Affiliation
Alexandria Egypt Lecture of Nutrition
Role Name Email Phone Street address
Principal Investigator Noha Hamdy nohaalaaeldine@yahoo.com 020110000020 Somuha
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Clinical Pharmacy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data sheets Study Protocol within 9 months upon the quality of request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information