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.: PACTR202107530985857 Date of Approval: 26/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Developing a package to improve hypertension control in Nigeria
Official scientific title Developing a package to improve hypertension control in Nigeria
Brief summary describing the background and objectives of the trial Background: Nigeria is experiencing increasing prevalence of hypertension. A greater cause for concern is the epidemic of premature cardiovascular mortality and early onset. Prevalence of hypertension in Nigeria ranges from 10.3 to 36.5% depending on the state. Our team found prevalence of hypertension to be 33.1%, and 20.4% in adults in Ibadan. Unfortunately, there is limited capacity to effectively tackle the increasing trend in Nigeria. Hypertension care is mostly hospital-based (secondary and tertiary settings), overwhelming a health service that is already imperiled by inadequate facilities. Meanwhile, primary health care facilities close to the populace are less patronised and ill-equipped for hypertension care. These factors have limited access to hypertension care with many people undetected or poorly managed. Various strategies including task shifting whereby community/home-based interventions using Community-based Oriented Resource Persons (CORPs) to improve access and support health care such as for cardiovascular disease have been tested across the globe. However, strategies in a region/country may not be applicable in another. Hence the need to search for local and effective alternative hypertension control strategy. Aim: This study is to develop a package to improve hypertension control in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DePIHCoN
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2021
Actual trial start date
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental 6 months i. Community-based screening of blood pressure by trained CORPs, and linkage of individuals with elevated blood pressure to health facilities., ii. Diagnosis confirmation, initial treatment in the primary healthcare facility, and monthly follow-up care by CORPs iii. health education on hypertension and healthy lifestyle. iv. SMS messaging for healthy lifestyle and treatment adherence support 300
Control Group Control 6 months i. Medical records at the health facility of their chioce will be checked monthly. ii. Home visit after 6 months to have the post-intervention assessment administered. 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Willingness to participate in the study 2. Plan to be resident in the community for at least one year after enrollment 3. Newly diagnosed hypertensives 4. Old patients receiving treatment and not controlled or not on treatment 1. Patients with clinically established complications and cardiovascular diseases 2. Patients needing or on special medical services 3. Patients on any form of health insurance scheme [make this a matching variable] 4. Pregnant women 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 89 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 14/10/2019 UI UCH Ethics committee
Ethics Committee Address
Street address City Postal code Country
Institute of advanced medical research and training, College of Medicine, University of Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome i. Mean change in blood pressure Post intervention
Secondary Outcome i. Mean improvement in Quality of life score ii. Proportion of patients with controlled blood pressure iii. Proportion of patients adhering to medication iv. Percentage increase in satisfaction with care v. Incidence of cardiovascular events (CVEs) vi. Proportion of CORPs assessed to have good competency score vii. Mean cost of treatment of hypertension and cost of hospitalization due to CVEs Post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Epidemiology and biostatistics research unit Institute of advanced medical research and training, College of Medicine, University of Ibadan Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tertiary education trust fund No 6 Zambezi Crescent, Off Aguiyi Ironsi St, Maitama Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tertiary education trust fund No 6 Zambezi Crescent, Off Aguiyi Ironsi St, Maitama Abuja Nigeria National research fund
COLLABORATORS
Name Street address City Postal code Country
Oyo State ministry of health Oyo State Government Secretariat, Agodi, Ibadan, Oyo State, Nigeria Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator IkeOluwapo Ajayi ikeajayi2003@yahoo.com +2348023268431 Epidemiology and biostatistics research unit, Institute of advanced medical research and training, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries IkeOluwapo Ajayi ikeajayi2003@yahoo.com +2348023268431 Epidemiology and biostatistics research unit, Institute of advanced medical research and training, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Catherine Falade lillyfunke@yahoo.com +2348033264593 Institute of advanced medical research and training, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Chairperson Ethical review committee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data may be made available based on reasonable request. Study Protocol Beginning Three years following article publication Data may be granted with permission from the principal Investigator to researchers, Academics and post graduate students who provide methodological sound proposal. Descriptive and differential data analysis may be carried out based on the objective of the approved study.
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