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.: PACTR202109562160747 Date of Approval: 15/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Insights on type 2 Diabetes mellitus management from Ethiopian perspective and evaluation of the impact of a pharmaceutical care on clinical outcome and medication adherence in type 2 Diabetes mellitus patients: A randomized controlled study.
Official scientific title PCT2DMEP
Brief summary describing the background and objectives of the trial Background: Several studies have established positive effects of pharmaceutical care on achieving glycemic control, clinical outcomes and medication adherence in patients with diabetes. Nevertheless, clinical pharmacists in Ethiopia do not typically provide pharmaceutical care. Objective: To evaluate the impact of pharmaceutical care (PC) interventions on glycemic control, clinical outcomes and medication adherence.
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 Pharmaceuical care service
Anticipated trial start date 01/01/2020
Actual trial start date 01/03/2020
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date 30/08/2020
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 173
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
REF NO 0078 Wachemo University Comprehensive Specialized hospital medical Ethical and research ethics evaluation committe
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pharmaceutical care services every 3 months 6 months Following randomization and the baseline assessment, the clinical pharmacist ensured patients visit every month for the assessment of pharmacological and non-pharmacological needs, while the routine follow up was every three months. After the patient meeting with the physician, the clinical pharmacist interviewed and provided in a separate office located next to the physician’s office at the outpatient clinic ,a structured patient education and discussion about type 2 diabetes, risks for and types of complications from diabetes, prescribed drug therapy, proper dosage, possible side effects and simplification of dosage regimens if deemed appropriate, taking account of the latest American Diabetes Association (ADA) recommendations (14) and the importance of medication adherence. The clinical pharmacists also emphasized lifestyle management as follows: patients were encouraged to (a) healthy lifestyle, (b) self-monitoring of glycemic control (SMBG) and (c) medication adherence. 87
Control Group Pharmaceutical care services every 3 months 6 months Patients in the CG received their usual care but did not receive clinical pharmacist on disease, medications, or necessary self-care activities and did not receive the 4 weekly telephone follow-up calls from the clinical pharmacist. These patients did not usually receive telephonic or mailed reminders for their upcoming appointments. Patients in the usual care group did, however, receive the usual care provided by the medical and nursing staff; this included patient assessment, a 3- or 6-month review at which blood glucose, blood pressure, liver function tests and kidney function tests were measured 86 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
If they were aged 18 years or older Treated at WUNEMMCS Hospital and diagnosed with type 2 diabetes at least 6 months previously, Took at least 1 prescribed medication for diabetes Had regular visits for last 6 months with or without concomitant Willingness to participate If they were missing visits in the previous six months Not willing to participate Participated in DM educational programs in the last 3 months Mentally incapable to participate Other types of diabetes Pregnancy Comorbidity of cancer, organ failure, or other severe diseases Unable to communicate and understand Amharic language Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 76 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 10/02/2020 Wachemo University Nigist Elleni Mohammed Memorial Comprehensive Specialized Hospital Medical ethics and research ethics committee
Ethics Committee Address
Street address City Postal code Country
Hadiya zone administrator north hosanna 22 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was change in fasting blood glucose (FBG) every 3 months
Secondary Outcome All other data collected, including blood pressure, serum lipid values (LDL-C, HDL-C, TC and TG), liver function tests (AST, ALT, ALP),kidney function parameters ( BUN, SrCr, eGFR) and medication adherence every 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wachemo University Nigist Elleni Mohammed Memorial comprehensive specialized hospital Hadiya zone administrator road north Hosanna 22 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wachemo University research and community vice president Addis street to Hossana midway from ambicho Hossana 667 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wachemo University research and community vice president Addis to Hossana street midway to ambicho hossana 667 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bruke Billoro 3b2005pharm@gmail.com +251913231628 St.Mary church south west
City Postal code Country Position/Affiliation
Hossana Ethiopia PhD canicdate.
Role Name Email Phone Street address
Public Enquiries ABDIKAREM ABDI daud87@hotmail.com +905449694997 34755 Istanbul Turkey
City Postal code Country Position/Affiliation
Istabul Turkey Department of Clinical Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Bilgen Basgut bilgenbasgut@gmail.com +905333396139 06790 Etimesgut / Ankara
City Postal code Country Position/Affiliation
Ankara Turkey Department of Pharmacology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets used and/or analyzed during the current study will be made available from the corresponding author on reasonable request. Informed Consent Form upon request of the journals Eligibility criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/09/2021 Result - 09/09/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information