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.: PACTR202311849462910 Date of Approval: 14/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical and Humanistic Outcomes of Pharmaceutical Care Interventions for Type 2 Diabetes Patients: A Randomized Controlled Trial.
Official scientific title Clinical and Humanistic Outcomes of Pharmaceutical Care Interventions for Type 2 Diabetes Patients: A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Several Randomized Controlled Trials (RCTs) have shown that Pharmaceutical Care Interventions (PCIs) developed and implemented by pharmacists in collaboration with other healthcare team members improve the quality of care of patients with type 2 Diabetes Mellitus (T2DM). Most of these studies considered Glycosylated Haemoglobin A1C (HbA1c) and other cardiovascular risk factors. Still, they did not report important clinical outcome measures such as the use of Point-of-Care Tests (PCTs) for clinical evaluation of HbA1c, Fasting Blood Glucose (FBG), and lipid profile, as well as, management of Drug Therapy Problems (DTPs), especially counterfeit medication problems which are known to be catastrophic if not prevented by the pharmacist and is taken by the patient. Sequel to the recommendations that PCTs can improve glycemic control in rigorous studies addressing all aspects of diabetes care, this study was designed with the objective of determining the impact of PCIs on a range of primary and secondary clinical and humanistic outcomes measures of care of ambulatory type 2 diabetes mellitus patients attending the outpatient diabetology clinic of the Federal Medical Centre Abakaliki, randomized to pharmaceutical care or traditional care, with considerations for PCTs, HbA1c, etc. The primary clinical and humanistic outcome measures chosen were reductions in HbA1c and improvement in the physical/ mental domain scores of the Short Form - 12 (SF-12) Health-Related Quality of Life (HRQoL) questionnaire at the end of the study respectively. The secondary clinical outcome measures chosen were reductions in FBG, Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), the 10-year risk of Coronary Heart Disease (CHD), and Body Mass Index (BMI), as well as, increase in High-Density Lipoprotein Cholesterol (HDL-C), and increase in the percentage of DTPs resolved at the end of the study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Pharmaceutical Care Intervention
Anticipated trial start date 01/02/2011
Actual trial start date 02/05/2011
Anticipated date of last follow up 01/11/2011
Actual Last follow-up date 31/01/2012
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL Not applicable
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual Care Monthly six (6) months Patients randomized to the control group received usual pharmaceutical services in the hospital delivered by other pharmacists who are not trained in the delivery of pharmaceutical care interventions. 8 Placebo
Experimental Group Pharmaceutical Care Intervention Daily, weekly, and monthly where applicable. Six (6) months Patients randomized to the intervention group received pharmaceutical care from the research pharmacist using a stepwise approach as follows: Step 1: Establishing a professional/ therapeutic relationship with the patients and other healthcare providers. This was done by using principles of good communication skills and showing empathy to patients with regular phone calls and home visitations where applicable. Step 2: Collecting patient-specific subjective and objective data, by direct patient interview, review of the patient’s medical records, visual drug inspections, and point-of-care testing tools. Step 3: Evaluating the data and identifying health and Drug Therapy Problems, using critical thinking skills and pharmacotherapy skills to review the patient’s subjective and objective data collected in an integrated manner to detect the 7 major classes of drug therapy problems such as unnecessary drug therapy, wrong drug, dosage too low, dosage too high, adverse drug reaction, inappropriate adherence, and needs additional drug therapy, as well as, their 34 subclasses whether as potential or actual drug therapy problems. Step 4: Developing and Implementing a pharmaceutical care plan (pharmacist's interventions). Here, problem-solving skills, in addition to, communication, critical thinking, and pharmacotherapeutic skills were employed to resolve all health and DTPs identified at the patient’s and/ or healthcare provider’s level. The actual pharmaceutical care plans implemented include pharmacotherapeutic goal setting, pharmacotherapeutic regimen modifications, Patient Medication and Education Counselling, Therapeutic Lifestyle Counselling, drug dispensing, generic/ therapeutic drug substitution, and drug dispensing referrals. Step 5: Evaluating and monitoring the interventions and follow-up. Step 6: Documentation of pharmaceutical care activities, done manually on a specially designed documentation sheet stored in a pharmaceutical care folder opened for each patient. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Ambulatory patients with a confirmed diagnosis of type 2 diabetes mellitus. 2. Patients on oral hypoglycemic therapy for over 6 months. 3. Patients resident within Abakaliki capital territory. 4. Patients with functional mobile phone numbers. 5. Patients who consented to the study orally. 1. Patients who are pregnant. 2. Patients with secondary forms of hypertension. 3. Patients below 30 years. 4. Patients resident outside the Abakaliki Capital Territory urban settlement. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 100 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 25/05/2010 Federal Medical Centre Abakaliki Ethical Committee
Ethics Committee Address
Street address City Postal code Country
1 Chidume Street Abakaliki 480241 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary clinical outcome measures chosen were a reduction in Glycated Haemoglobin A1c and Fasting Blood Glucose levels at the end of the study. The primary humanistic outcome measure chosen was improvement in the physical and mental domain scores of the short form - 12 health-related quality of life questionnaire at the end of the study. Baseline and at end of the study.
Secondary Outcome Reductions in systolic blood pressure, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, triglycerides, 10-year risk of coronary heart disease and body mass index, as well as, an increase in high-density lipoprotein cholesterol, increase in the percentage of drug therapy problems identified and resolved at the end of the study. Baseline and at end of the study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Abakaliki 1 Chidume Street Abakaliki 480241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Federal Medical Centre Abakaliki 1 Chidume Street Abakaliki 480241 Nigeria
PineCrest Healthcare Ltd J83WJCM off Balogun Bus Stop, Obafemi Awolowo Way Ikeja 100271 Nigeria
Solix Pharmaceuticals and Healthcare Company Limited 12 Fide Mbam Road Abakaliki 480281 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Federal Medical Centre Abakaliki 1 Chidume Street Abakaliki 480241 Nigeria Hospital
Secondary Sponsor Solix Pharmaceuticals and Healthcare Company Limited 12 Fide Mbam Road Abakaliki 480281 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Assoc. Prof. C. V. Ukwe Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria Nsukka Nsukka 410001 Nigeria
Dr. J. M. Okonta Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria Nsukka Nsukka 410001 Nigeria
Dr. P. O. Ezeonu Federal Medical Centre Abakaliki, 1 Chidume Street Abakaliki 480241 Nigeria
Dr. B. C. Ezeokpo Federal Medical Centre Abakaliki, 1 Chidume Street Abakaliki 480241 Nigeria
Pharm. Dr. A. K. Anya Federal Medical Centre Abakaliki, 1 Chidume Street Abakaliki 480241 Nigeria
Solix Pharmaceuticals and Healthcare Company Limited 12 Fide Mbam Road Abakaliki 480281 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Solomon Ikechukwu Okorie solokatx@yahoo.com +2348034301628 Department of Pharmaceutical Services, Federal Medical Centre Abakaliki, 1 Chidume Street
City Postal code Country Position/Affiliation
Abakaliki 480241 Nigeria Clinical Pharmacist
Role Name Email Phone Street address
Public Enquiries Paul Olisaemeka Ezeonu info@aefutha.gov.ng +2348035673439 Federal Medical Centre Abakaliki, 1 Chidume Street
City Postal code Country Position/Affiliation
Abakaliki 480241 Nigeria Medical Director
Role Name Email Phone Street address
Scientific Enquiries Victoria Chinwe Ukwe chinwe.ukwe@unn.edu.ng +2348037782447 Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Research Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes. There is a plan to make all collected IPD and related data dictionaries available. Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol Within 6 months after publication. IPD and any additional supporting information will be shared upon request to the principal investigator via the email solokatx@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Within six months of publication all study data would be made available at https://data.mendeley.com Yes 08/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 08/11/2023 Result - 08/11/2023 Result - 08/11/2023 Result - 08/11/2023 Result - 08/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information