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.: PACTR202303569804588 Date of Approval: 31/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pharmaceutical Care intervention on blood pressure control in Chronic Kidney Disease
Official scientific title Randomized control trial to Assess the effect of Pharmaceutical care Intervention on blood pressure control among adult chronic kidney Disease patient (RAPID Study)
Brief summary describing the background and objectives of the trial There is a very high prevalence of hypertension in CKD patients with studies reporting 85 – 95%. Uncontrolled hypertension as a risk factor for developing CKD is associated with a more rapid progression of CKD and is the second leading cause of ESRD. However, achieving and maintaining adequate BP control in this CKD population is quite challenging. This has often been attributed to factors such as presence of comorbidities, poor compliance, frequent medication/dosage changes, and dialysis. Hence, more interventions to improve hypertension in CKD are really needed. The importance of a multidisciplinary-team-based CKD care which involves pharmacists (pharmaceutical care) cannot be overemphasized. This study aim to evaluate the impact of pharmaceutical care in achieving a mean change (decrease) in systolic blood pressure (SBP) of patients with CKD from baseline to 6 months of follow-up. Other secondary objectives are mean change in DBP, progression of disease (eGFR) and HRQoL
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RAPID
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/05/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date 30/04/2024
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pharmaceutical Care Four sessions (Baseline, 2nd, 4th and 6th month) 6 months Participants randomized to the intervention group will receive 4 consecutive 15 - 20 mins of Pharmaceutical care which is a face to face exclusive interview and structured educational sessions from a clinical pharmacist trained in Kidney pharmacotherapy at baseline, 2nd, 4th and 6th month of follow-up. They will be provided with information on the Chronic kidney disease & risk factors; laboratory evaluations; importance of medications compliance; and diet & lifestyle targeted at improving their quality of life using validated tools. Furthermore, at the end of each session, the participants will be provided a copy patient information leaflets/pictograms for reference and guidance. They will be followed-up via mobile phone calls, text messages and whatsApp every month to review previous sessions and be reminded of their clinic appointment date for data collection. 54
Control Group Usual Care Four sessions (Baseline, 2nd, 4th and 6th Month) 6 months Participants randomized to the control group will receive usual care from the clinicians (nephrologists), nurses and prescriptions refilled at the pharmacy department. They will be interviewed by the clinical pharmacist and assessed at baseline but will not be provided with active intervention (Pharmaceutical Care). Phone calls will be made to remind them of their clinic appointment for data collection. 54 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients ≥18 years diagnosed with CKD stages 3 and 4 • CKD related to hypertension and diabetes. • Outpatients who have been attending the renal clinic > 6 months • CKD patients with uncontrolled BP ≥140/90mmHg • Patients willing and able to give informed consent to participate in the study • Inpatients, dialysis, ESRD (Stage 5), Post renal transplant patients • unable or unwilling to provide consent • institutionalized (e.g. prisoner, nursing home resident or skilled nursing facility resident) • Pregnant or breast-feeding women • Currently participating in an interventional clinical trial or in a research study that adds significantly to the participant’s burden • Currently diagnosed with Acute kidney Injury, Nephrotic disease, Impaired mental status, Lupus, Sickle Cell Disease, Polycystic Kidney Disease Adult: 19 Year-44 Year 18 Year(s) 80 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 09/03/2023 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Rm 107, 1st Floor, LUTH Administrative Block, Idi-Araba, Lagos Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean change in systolic blood pressure (SBP) of patients with CKD from baseline to 6 months of follow-up. baseline, 2nd, 4th and 6th month
Secondary Outcome 1. Mean change in eGFR and UACR values from baseline to 6 months of follow-up. 2. Mean change in diastolic blood pressure from baseline to 6 months of follow-up. 3. Mean change in HRQoL domains from baseline to 6months of follow-up Baseline, 2nd, 4th and 6th Month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Ishaga Road, Idi-Araba 102215, Lagos Lagos Nigeria
Lagos State University Teaching Hospital 1-5, Oba Akinjobi Road, G.R.A, Ikeja Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Akinola Alexander A 3, Brown Road, Aguda, Lagos Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akinola Alexander A Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, CMUL Compound, Ishaga Rd, Idi-Araba Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Joda Arinola E Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, CMUL Compound, Ishaga Road, Idi-Araba, Lagos Lagos Nigeria
Dr. Aderemi Williams R.I Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, CMUL Compound, Ishaga Road, Idi-Araba, Lagos Lagos Nigeria
Prof. Amira C.O Renal Unit, Lagos University Teaching Hospital, Ishaga Road, Idi-Araba, Lagos Lagos Nigeria
Prof. Awobusuyi J.O Nephrology Unit, Lagos State University Teaching Hospital, 1-5, Oba Akinjobi Road, G.R.A, Ikeja Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alexander Akinola alexakinola@unilag.edu.ng +2348037307362 3, Brown Road, Aguda, Surulere Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer II
Role Name Email Phone Street address
Public Enquiries Alexander Akinola alexakinola@unilag.edu.ng +2348037307362 3, Brown Road, Aguda, Surulere, Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer II UNILAG
Role Name Email Phone Street address
Scientific Enquiries Alexander Akinola alexakinola@unilag.edu.ng +2348037307362 3, Brown Road, Aguda, Surulere, Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer II
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, after de-identification, will be shared within 12 months of completion to researchers as results in a publication. The link to the publication will be accessible to anyone indefinitely on the trial registry. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Indefinitely Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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