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.: PACTR201903495704553 Date of Approval: 07/03/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Pharmaceutical Care by Community Pharmacist on Type 2 Diabetes Outcomes: A Cluster Randomized Controlled Study
Official scientific title Impact of Pharmaceutical Care by Community Pharmacist on Type 2 Diabetes Outcomes: A Cluster Randomized Controlled Study
Brief summary describing the background and objectives of the trial Background Less than a third of diabetes patients attain glycemic target in Nigeria.Pharmacist led diabete interventions have been shown to improve the clinical outcomes amongst diabetic patients in developed countries.However, it is unclear whether such interventions could be applied successfully in Nigeria community pharmacies. Objectives of the trial are - To evaluate the impact pharmaceutical care by community pharmacists on health outcomes- HbA1c, FBS,blood pressure, BMI,Total cholesterol and triglycerides, medication adherence,self care and quality of life - To assess the cost-benefit of community pharmacist-based diabetes management program
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Type 2 Diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/04/2018
Actual trial start date
Anticipated date of last follow up 30/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
COOUTH/AC/VOI.X1/0024 Ethical Committee, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Amaku Awka
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pharmaceutical care package Patients will be seen by the pharmacist at months 0,1,3, and 6, given a total of four appointments during the 6 months duration. Body mass index (BMI), blood pressure (BP) and blood glucose will be measured in the pharmacy at each visit; glycosolated hemoglobin (HbA1c), total cholesterol (TC) and triglycerides, will be assessed at the baseline and the end of the study. 6 months Pharmaceutical package/Pharmacists’ roles in the intervention group are; Diabetes self management education regarding diabetes and lifestyle modifications; monitoring of fasting blood glucose, BP, BMI, Hb A1c, TC, and triglycerides; medication adherence support; patient medication review with aim at identification of DRPs; regular follow-up and reminding patients of the importance of regular examinations for diabetic complications, for example eye and feet examination; referral to patients’ GP when appropriate, and recommend therapy change to patients’ GP when apprioprate; and usual care. 45
Control Group Usual care The pharmacists will meet with the patients at least 2 times within the six months. The first meeting at the beginning of the study while the last meeting at the end of the study. Other appointment will be at the demand of the patients. 6 months Usual care includes the normal services obtainable in the community pharmacy which typically involves dispensing of drugs with or without counseling. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients must have been diagnosed of Type 2 diabetes Patient must be taking at least one glucose lowing medication or insulin Above 18 years No significat co-morbidity Not involved in any trial/ study during last 3 months Able to attend regular visits Not diagnosed with of thyroid disorder, gestational, type 1 diabetes, cardiac heart failure, end stage renal disease, hepatitis or cancer The patient is not enrolled in other concurrent educational program 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 05/02/2018 Chukwuemeka Odegwu Ojukwu University teaching Hospitat etical committee Teaching
Ethics Committee Address
Street address City Postal code Country
Amaku Awka Awka 420263 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycosolated hemoglobin (HbA1c) Measured at baseline and end of the study at 6 month
Primary Outcome Fasting blood glucose (FBG) Measured at baseline and end of the study at 6 month
Secondary Outcome Total cholesterol and Triglyceride At the beginning of the study At the end of the study after 6 month interval
Secondary Outcome Medication adherence, self care quality of life and diabetes knowledge test of the patient Measured with medication adherence scale, diabetes self management questionnaire, EQ-5D, and Diabetes knowledge questionnaires at least in the beginning and end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Vipat Pharmacy Ltd 39 Awka Rd Onitsha Nigeria
Lawcy Pharmacy Ltd 4 Central School Rd Onitsha Nigeria
Your Health Pharmacy Ltd 41 Ogbatuluenyi str Federal H/ Estate Onitsha Nigeria
God's Care Pharmacy Ltd 1 Umunya str Omagba phase 1 Onitsha Nigeria
Omed Pharmacy Ltd 46 Modebe Avenue Onitsha Nigeria
Arimans Pharmacy Ltd 1 Court Rd Onitsha Nigeria
Pax Pharmacy Ltd 24 Awka Rd Onitsha Nigeria
Eggovin Pharmacy Ltd 24 Ifitedunu str Omagba Onitsha Nigeria
Hallmed Pharmacy Ltd 62 Awka Rd Onitsha Nigeria
Isechem Pharmacy Ltd 54 Akuzo str Nkpor Onitsha Nigeria
XL Pharmacy Ltd 22 Awka Rd Onitsha Nigeria
Samino Pharm. Ltd 30 Nwaziki Avenue Awada Obosi Nigeria
Malix Pharmacy Ltd 2 Central school Rd Onitsha Nigeria
Austinola Pharmacy ltd 1 Okija str Iyiowa Anambra state Nigeria
Royal Dock Pharmacy Ltd Jehovah Jireh Rd Akpaka , Onitsha Onitsha Nigeria
Pitsen pharmacy Ltd 58 Atani Rd, Odekpe Odekpe Onitsha Nigeria
Palvron Pharmacy Ltd 25 Olo street, Omagba phase 1 Omagba Onitsha Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tertiary Education Trust Fund (TETFund) Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nnamdi Azikiwe University Awka Nigeria University
COLLABORATORS
Name Street address City Postal code Country
DR OBINNA EKWUNIFE NNAMDI AZIKIWE UNIVERSITY Awka Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samuel Uzodinma pharmusamuel@yahoo.com +2348055509793 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
Role Name Email Phone Street address
Public Enquiries OBINNA EKWUNIFE oi.ekwunife@unizik.edu.ng +2347062032501 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
Role Name Email Phone Street address
Scientific Enquiries Sunday Nduka so.nduka@unizik.edu.ng +2348033644385 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data will include the clinical and humanistic parameters of participants at completion of the study at 6 months. Data are mean with standard deviation, median. change over 6 months are mean difference. Clinical Study Report,Informed Consent Form,Study Protocol The data will be available within 12 months of the actual completion date of the study and will be available for a time frame of three years. Open access to anybody who has need of the study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
The journals' websites to be determine later during publication 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