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.: PACTR202010543945594 Date of Approval: 26/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pharmacist-led care and treatment outcomes in uncontrolled type 2 diabetes
Official scientific title Evaluation of Pharmacist-Led Care on Treatment Outcomes in Patients with Uncontrolled Type 2 Diabetes Mellitus in Abubakar Tafawa Balewa Hospital, Bauchi State, Nigeria
Brief summary describing the background and objectives of the trial The management of diabetes mellitus is complex and multi-dimensional, requiring a multi-professional approach by health care providers and a substantial self-care practice by the patients, to achieve desired care outcomes. Diabetes is a major cause of death worldwide and was responsible for the death of four million, two hundred thousand (4,200,000) people in 2019. approximately 463 million people in the world had diabetes at the end of 2019, with Africa accounting for 19 million and Nigeria bearing the highest burden after South Africa. A 2018 meta analysis by Uloko and colleagues estimated the prevalence of diabetes in Nigeria as 5.8%, which is a testimonial to the epidemic nature of the disease in the country, requiring both health care providers and patients to collectively galvanise efforts towards combating the menaces. It is also reported that most diabetic patients have fair to poor control of their blood glucose and factors including non-adherence to prescribed medication, sedentary lifestyle, comorbidity, illiteracy and poverty are responsible for this poor outcome. This research therefore aims to evaluate the effect of pharmacist-led care on treatment outcomes in patients with uncontrolled T2DM
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 Education /Training
Anticipated trial start date 25/10/2017
Actual trial start date 22/11/2017
Anticipated date of last follow up 30/01/2019
Actual Last follow-up date 24/07/2019
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Completed
Publication URL nil
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 Pharmacist provided education adherence counselling telephone calls text messages and referral nil One (1) year Pharmacist-led care was delivered to patients in the intervention arm by the primary investigator (Pharm. Emmanuel Agada David). The components of the intervention include: • A structured patient education on T2DM, its complications, risk factors, prescribed therapy, proper dosage, possible side effects, • the importance of adherence and diabetes self-care (eye, kidney, foot and heart) • assessment and documentation of patients’ diabetes-specific biomarkers at follow-up visits • Telephone follow-up calls provided by the research pharmacist, after every 6 weeks for patients in the intervention arm to discuss and review prescribed therapy, emphasize the importance of adherence to medication treatment plan, the importance of self-care and to answer/clarify patients’ questions/concerns. • Referral Usual care patients simply kept appointments with physicians and received care from other medical staff like nurses and medication refill from the pharmacy 54
Control Group Standard or Usual care involves keeping appointments with physician and receiving care from other me nil One (1) year Standard or Usual care involves keeping appointments with physician and receiving care from other medical staff like nurses or medication refill from the pharmacy without any input by the research pharmacist. 54 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• A clinical diagnosis of T2DM • Age 18 years and above • Patient has been diagnosed with the disease for atleast 6 months or more (not a newly diagnosed patient) • Patient is not pregnant • Patient is on oral anti-diabetic agents • Patient is taking not less than two medications • Patients’ AIC ≥ 7.0 • Critically ill patients • Unconscious patients • Patients with AIC < 7 • Patient being managed on only medical nutritional therapy • Patients without phone or phone number • Patient undergoing dialysis • Patient on erythropoietin or other haematinic medication Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 25/10/2017 Abubakar Tafawa Balewa University Teaching Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road, off Yandoka Street Bauchi 740211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycaemic control using glycated haemoglobin test baseline, sixth, 6th month and twelfth, 12th month
Secondary Outcome Secondary outcomes include Blood pressure, lipid profile, medication adherence assessment, self-monitoring of blood glucose and quality of life assessment baseline, sixth, 6th month and twelth, 12th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abubakar Tafawa Balewa Teaching Hospital Bauchi Nigeria Hospital Road, off Yandoka Street Bauchi 740211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The principal investigator is the sponsor Name Emmanuel Agada DAVID Federal Lowcost, off Goodluck Jonathan Road Gombe 760211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Emmanuel Agada David Federal Lowcost, off Goodluck Jonathan Road, Gombe State Gombe 760211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Mrs. Roseline I. Aderemi William Idi-Araba Surulere - Lagos State Nigeria Lagos 101283 Nigeria
Dr. Mrs. Rebecca O. Soremekun Idi-Araba, Surulere Lagos State, Nigeria Lagos 101283 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Agada David emmagada@yahoo.co.uk +2348039681589 Federal Lowcost, off Goodluck Jonathan Road, Gombe
City Postal code Country Position/Affiliation
Gombe 760211 Nigeria Lecturer Gombe State University
Role Name Email Phone Street address
Scientific Enquiries Roseline Aderemi William iberose31@yahoo.com +2348033061996 Idi-Araba, Surulere
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Senior Lecturer Faculty of Pharmacy University of Lagos
Role Name Email Phone Street address
Public Enquiries Rebecca Soremekun rebeccasoremekun@yahoo.com +2348033186457 Idi-Araba, Surulere
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Associate Professor Faculty of Pharmacy University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A. IPD Sharing Statement S/No. Description Baseline 6th Month 12th Month 1 Patients data available for sharing Yes Yes Yes 2 Data to be shared Demographics, glycated haemoglobin, fasting blood glucose, blood pressure and lipid profile Comparison of glycaemic control, blood pressure and lipid profile between intervention and control group Comparison of glycaemic control, blood pressure and lipid profile between intervention and control group after de identification 3 Other documents Study protocol, inform consent form, data analysis Study protocol, inform consent form, data analysis Study protocol, inform consent form, data analysis 4 When data will be available Immediately following publication Immediately following publication Immediately following publication 5 Who data will be available to To host institution and others will be on request To host institution and others will be on request To host institution and others will be on request 6 For what type of analysis To achieve the aim in the approved proposal (influence diabetes management protocol) To achieve the aim in the approved proposal (influence diabetes management protocol) To achieve the aim in the approved proposal (influence diabetes management protocol) and for inclusion in meta analysis 7 Mechanism for data availability proposal to be directed to emmagada@yahoo.co.uk proposal to be directed to emmagada@yahoo.co.uk proposal to be directed to emmagada@yahoo.co.uk B. RESULT REPORTING 1. Date of posting summaries: As soon as publication is done – propose April 2021 2. Date of first journal publication results -- propose April 2021 3. URL hyperlink(s) related to results and publications – to be available after publication(s) 4. Baseline Characteristics: Socio-Demographic Characteristics of Participants at Baseline Characteristics Sub-group Treatment group Total Chi-square (P value) Intervention n (%) Control n (%) n (%) Gender Female 33 (61.11) 41 (75.93) 74 (68.52) 2.747 (0.1) Male 21 ( Informed Consent Form,Statistical Analysis Plan,Study Protocol Other IPD include consent form, medication adherence assessment tool, self-monitoring of blood glucose and quality of life assessment tool The principal research pharmacist provided educational interventions, medication adherence counselling, referral intervention and followed up patients in the intervention arm for 12 months through phone calls, text messages and clinic appointment visits. Data were collected for patients in both intervention and control arms at baseline, 6th and 12 month. Analysis plan is given below: Means and standard deviation (SD) or median and interquartile range (IQR) were reported for continuous variables, depending on the distribution of the data obtained, while categorical variables were described using frequencies and proportions. Baseline characteristics and resultant clinical and biochemical characteristics of patients in the intervention and controlled arms were compared using Pearson chi-square test for categorical variables and appropriate parametric and non-parametric test, depending on the distribution of the continuous variables using Version 23.0 of Statistical package for social sciences (SPSS) (IBM Corp, Armonk, New York, USA). Bivariate analysis was conducted to assess for any association between pharmacist-led intervention and adherence, control of clinical biomarkers and quality of life, while variables with P≤ 0.05 were included in a multivariable logistic regression model to identify confounders.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
nil Yes 14/10/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks nil
Changes to trial information