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.: PACTR202311731445746 Date of Registration: 28/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outcomes of Pharmaceutical Care Interventions in Type 2 Diabetes Mellitus Patients: A Pre-Post Pilot Study At Federal Medical Center Abakaliki, Ebonyi State, Nigeria.
Official scientific title Clinical And Humanistic Outcomes of Pharmaceutical Care Interventions in Type 2 Diabetes Mellitus Patients: A Pre-Post Pilot Study At Federal Medical Center Abakaliki, Ebonyi State, Nigeria.
Brief summary describing the background and objectives of the trial Several studies have shown that pharmaceutical care (PC) improves the quality of care for patients with type 2 diabetes mellitus (T2DM). Although most of these studies considered glycosylated hemoglobin (HbA1C) and other cardiovascular risk factors, they did not report important clinical outcomes such as identification and management of drug therapy problems (DTPs), as well as, use of Point of Care Tests (POCTs) for clinical evaluation of HbA1C, fasting blood glucose (FBG) and lipid profile. However, some studies also showed that patients with T2DM are at an increased risk of having more DTPs compared to non-diabetics, but they did not report important DTPs such as counterfeit medication problems (CMPs), which could be catastrophic if consumed by patients when not prevented by the clinical pharmacist. In line with the recommendation that PC studies should be designed to address all aspects of diabetes care, this study was designed to determine the impact of PC on ambulatory hospital-based T2DM patients in a prospective, single group, pre-post study, with considerations for HbA1C, cardiovascular risk factors, DTPs (especially CMPs) and POCTs. Furthermore, at the time of the design of this study and to the best of our knowledge, no published studies have shown the benefits of PC in T2DM patients in Nigeria. The majority of the studies that showed that PC can benefit T2DM patients were conducted in developed countries, so the relevance of these studies to developing countries like Nigeria is therefore limited and the evidence about the effectiveness of PC in T2DM patients within Nigeria's healthcare system and other developing countries remains weak, hence the need for the study to address the problem as advocated by the World Health Organization and International Pharmaceutical Federation.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Kidney Disease,Musculoskeletal Diseases,Nutritional, Metabolic, Endocrine,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Pharmaceutical Care
Anticipated trial start date 03/05/2010
Actual trial start date 30/06/2010
Anticipated date of last follow up 31/01/2011
Actual Last follow-up date 31/01/2011
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 16
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
Single Group Non-randomised 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 Not Applicable Six (6) months Patients eligible for the study received pharmaceutical care (PC) from the research pharmacist who has undergone postgraduate PC competency training, using a stepwise approach as follows: Step 1: Establish a professional/ therapeutic relationship with the patients and other healthcare providers using 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, reviewing the patient’s medical records, visual drug inspections, and using point-of-care testing tools. Step 3: Evaluating the data and identifying health and Drug Therapy Problems (DTPs), using critical thinking and pharmacotherapy skills to review the patient’s subjective and objective data collected in a sequence to detect the 7 major classes of DTPs 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 DTPs. Step 4: Develop and Implement a PC plan (pharmacist's interventions) using vital skills like problem-solving skills, communication, critical thinking, and pharmacotherapeutic skills to resolve all health and DTPs identified at the patient’s and healthcare provider’s level. The PC 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: Evaluate and monitor the interventions and follow up on a daily, weekly, or monthly basis as the case may be. Step 6: Documentation of PC activities, done manually on a specially designed documentation sheet stored in a pharmaceutical care folder opened for each eligible patient. 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with confirmed diagnosis of type 2 diabetes mellitus. 2. Patients on oral hypoglycaemic therapy for over six (6) months. 3. Patients with poor glycaemic and poor blood pressure and/ or poor lipid control. 4. Patients who the Consultant Endocrinologist of the hospital consented to their entry into the trial. 5. Patients who consented to the study by giving oral consent. 1. Patients with secondary forms of hypertension. 2. Patients who were pregnant 3. Patients resident outside urban settlements within the study site. 4. Patients without mobile phone numbers. 5. Patients on insulin therapy. 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) 120 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 Center Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Chidume Street Abakaliki 480321 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycated Haemoglobin A1c (HbA1c) measured using the In2it Analyzer model 501122R.1 0 and 6 months
Primary Outcome Drug therapy problems were identified using a stepwise approach and a specially designed data collection sheet. 6 months
Primary Outcome Health-related quality of life is measured using the short form – 12 (SF-12) questionnaire and evaluated using the online SF-12 Health Survey Scoring Demonstration. 0 and 6 months
Secondary Outcome Fasting Blood Sugar (FBS), measured using the Cardio-Check PA Analyzer model CE0197 daily, weekly, monthly and 6 months
Secondary Outcome Lipid profile (total cholesterol, low-density lipoprotein cholesterol, triglycerides, and high-density lipoprotein cholesterol) was measured using the Cardio-Check PA analyzer model CE0197. 0 and 6 months
Secondary Outcome 10–year risk of coronary heart disease (CHD) score evaluated using online health calculators. This calculator takes account of the patient’s age, gender, smoking status, blood pressure, total cholesterol, and HDL-C. 0 and 6 months
Secondary Outcome Body mass index (BMI), is evaluated using online health calculators. 0 and 6 months
Secondary Outcome Systemic blood pressure, measured using Omron M6 Comfort Automatic Blood Pressure Monitor model HEM-7321-E baseline, daily, weekly, monthly and 6 months
Secondary Outcome Improvement in the quality of prescribing done by the process of medication review. Here the research pharmacist discusses with the doctors regarding drug therapy and if necessary, treatment modifications were recommended as a follow-up to the pharmaceutical care plan, e.g. more intensive management of hypertension, hyperglycemia, dyslipidemia, or simplification of dosage regimen if deemed appropriate, taking account of the latest treatment guidelines. During the medication review, all drug therapy problems identified that required the attention of the physician or prescriber were presented to the consultant endocrinologist for appropriate management. baseline, weekly, monthly and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Center Abakaliki 1 Chidume street Abakaliki, Ebonyi State Abakaliki 480231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Federal Medical Center Abakaliki 1 Chidume Street Abakaliki Ebonyi State 480231 Nigeria
Pinecrest Healthcare Limited 11 Balogun Street Off Awolowo Way Ikeja Lagos 100271 Nigeria
Solix Pharmaceuticals and Healthcare Company Limited 12 Fide Mbam Road Abakaliki Ebonyi State 480211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pharm. Solomon Ikechukwu Okorie 1 Chidume Street Abakaliki Ebonyi State 480231 Nigeria Individual
Secondary Sponsor Federal Medical Center Abakaliki 1 Chidume Street Abakaliki Ebonyi State 480231 Nigeria Hospital
Secondary Sponsor Solix Pharmaceuticals and Healthcare Company Limited 12 Fide Mbam Road Abakaliki Ebonyi State 480211 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Solomon Ikechukwu Okorie solokatx@yahoo.com +2348034301628 1 Chidume Street, Department of Pharmacy, Federal Medical Center
City Postal code Country Position/Affiliation
Abakaliki Ebonyi State 480231 Nigeria Pharmacist
Role Name Email Phone Street address
Public Enquiries Paul Olisaemeka Ezeonu enquires@aefutha.gov.ng +2348035673439 1 Chidume Street, Federal Medical Center Abakaliki
City Postal code Country Position/Affiliation
Abakaliki Ebonyi State 480231 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 Enugu State 410001 Nigeria Professor 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. Clinical Study Report,Statistical Analysis Plan Within six 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 21/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/11/2023 Result - 21/11/2023 Result - 21/11/2023 Result - 21/11/2023 Result - 21/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information