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.: PACTR202010567204655 Date of Approval: 12/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Medication Therapy Management and Glycaemic Control
Official scientific title Impact of Medication Adherence Counselling on Glucose Control in Patients with Uncontrolled Type 2 Diabetes Mellitus
Brief summary describing the background and objectives of the trial Poor glucose control in patients with Type 2 Diabetes (T2DM) is common. This is widely attributed to non adherence to prescribed medications amongst other factors, resulting in increased risk of developing complications and mortality in diabetic populations. Medication adherence counselling is a major intervention strategy employed worldwide to improve glucose control in patients with T2DM, but relatively unexplored in Liberia. This study is thus aimed to assess the impact of medication adherence counselling on the glycaemic control of patients with T2DM, attending clinic at John F. Kennedy Memorial Medical Center, Monrovia, Liberia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Not Available
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 28/09/2020
Actual trial start date 05/10/2020
Anticipated date of last follow up 19/10/2020
Actual Last follow-up date 22/02/2021
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 108
Recruitment status Not yet recruiting
Publication URL Not Available
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 Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Educational and adherence counselling Four weeks interval Three months The research Pharmacists will provide patients in the intervention arm with 30 to 45 minutes face-to-face educational and adherence counselling sessions on two consecutive visits, at four weeks interval, in addition to usual care. The intervention package will include patient education on diabetes mellitus, risk factors, complications, importance of healthy diet, physical activity, self-monitoring of blood glucose and adherence to prescribed medications, while the usual care arm (control) will receive standard care from their regular clinic physicians 54
Control Group usual care as determined by the physician three months the usual care group will keep their clinic appointments with the physicians 54 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Type 2 diabetic patients Regular clinic attendance Patients with greater than or equal to 7mmol/L fasting blood glucose (FBG) Taking 1 or more anti-diabetic medication for at least 6 months Patients who refuse to sign written informed consent Patients below 19 years of age Gestational diabetes Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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 07/09/2020 Institutional Review Board Committee
Ethics Committee Address
Street address City Postal code Country
Tubman Boulevard, Sinkur Monrovia Monrovia 1973 Liberia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome fasting blood glucose Baseline and at three months
Secondary Outcome Blood pressure baseline and three month interval
Secondary Outcome Body Mass Index in kilogram/metre square baseline and three month
Secondary Outcome lipid profile base line and three month
Secondary Outcome medications baseline and through the three months period
Secondary Outcome level of adherence to prescribed medication baseline and three month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
John F. Kennedy Memorial Medical Center Tubman Boulevard, Monrovia Monrovia 50101 Liberia
FUNDING SOURCES
Name of source Street address City Postal code Country
West African Research Association 232 Bay State Road, Boston, MA 02215 Boston 02115 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor West African Research Association 232 Bay State Road Boston MA 02115 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Pharm George Flayflay Sobor 1000 Monrovia 10 Monrovia 91016 Liberia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel David emmagada@yahoo.co.uk +2348039681589 Good Luck Ebele Jonathan Road, Federal Lowcost
City Postal code Country Position/Affiliation
Gombe 760 Nigeria Lecturer 1 Gombe State University
Role Name Email Phone Street address
Public Enquiries Ezekiel Hallie ezefhallie@gmail.com +231886827479 1000 Monrovia
City Postal code Country Position/Affiliation
Monrovia 91016 Liberia Dean Faculty of Pharmacy University of Liberia
Role Name Email Phone Street address
Scientific Enquiries Joshua Peters petersjoshua7418@gmail.com +231886602902 Tubman Boulevard, Sinkor. Monrovia
City Postal code Country Position/Affiliation
Monrovia 91016 Liberia Head of Pharmacy Department. John F. Kennedy Memorial Medical Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data to be collected include social-demographic, clinical characteristics, medication history and level of adherence. These will include patients' age, gender, weight, height, level of education, occupational status, physical activity level, alcohol consumption rate, smoking status, family history of diabetes, duration of disease, fasting blood glucose, blood pressure and lipid profile Written informed consent Pharm. Emmanuel Agada David and Pharm George Flayflay Sorbor are lecturers from Gombe State University (Nigeria) and University of Liberia respectively. We are conducting a research among diabetes patients, attending clinic at John F Kennedy Memorial Medical Center. Purpose of the study: to evaluate the impact of medication adherence counseling on glucose control of patients with uncontrolled type 2 diabetes mellitus Potential Harm, Risks, or Discomfort: not expected Right to Refusal or Withdrawal You are kindly requested to sign below to confirm your consent to participate in this research and we promise to handle all information obtained from you with absolute confidentiality. Your participation is very vital and highly appreciated. However, it is voluntary and you have the freedom to participate, refuse or withdraw your participation at any stage of the study without any effect. Statement of understanding/consent I have understood the questions asked and explained to me and willing to participate in the study. Participant signature: …………………………. Date……………………. Investigators signature: ………………………… Data obtained would be analysed using version 21.0 statistical package for social sciences (SPSS). Continuous variables would be reported in proportions depending on the outcome of normality testing, while categorical variables would be described using univariate and/or multivariate statistics. Factors associated with adherence and glycaemic control and predictors would be assessed using logistic regression analysis. The differences between baseline and Three (3) months fasting blood glucose and adherence in IG and CG would be assessed using paired t test while comparison of final outcomes between IG and CG would be carried out using independent student t test. Informed Consent Form,Statistical Analysis Plan,Study Protocol baseline and three months interval Only patients with uncontrolled Type 2 Diabetes Mellitus (T2DM), who are eighteen (18) years of age or older (adults), have been regular at the clinic in the past 6 months, currently on antidiabetic medications and accept to participate in the study by signing a written informed consent will be participate in the study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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