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.: PACTR202309530525257 Date of Approval: 26/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Feasibility and preliminary efficacy of a homebased intervention for the control and management of hypertension amidst the COVID-19 Pandemic in Kiambu County, Kenya
Official scientific title Feasibility and preliminary efficacy of a homebased intervention for the control and management of hypertension amidst the COVID-19 Pandemic in Kiambu County, Kenya
Brief summary describing the background and objectives of the trial In Sub Saharan Africa (SSA) there is a growing burden of Non communicable diseases (NCDs) which poses a big challenge to the weak health system in these resource limited settings. As governments prioritize the control of the COVID 19 pandemic, consequences of chronic diseases such as cardiometabolic risk factors (CMRFs) continue unabated. The aim of this study is to explore innovative strategies to improve blood pressure and body composition through community health workers lifestyle interventions among hypertensive patients in low income populations of Kiambu County, Kenya. The specific objectives were; i. to determine the effectiveness of a multicomponent community health workers lifestyle intervention for control of BP among hypertensive patients in Kiambu County. ii. To determine the feasibility and acceptability of a multicomponent community health workers lifestyle intervention for control of blood pressure among hypertensive patients in Kiambu County.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 30/04/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
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
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community health worker homebased lifestyle intervention Monthly home visits 6 months In addition to the usual care participants received a homebased community health worker(CHW)–led intervention (health coaching, home blood pressure monitoring, blood pressure audit and feedback) implemented over a period of 6 months. This entailed two home visits by the trained CHWs during the first month after randomisation, followed by monthly follow-up visits for a period of 6 months. The initial visit was a 90-minute home visit to discuss general knowledge about hypertension and offer tailored counselling on lifestyle modification as well as set PA targets. Subsequent monthly visit was focused on social support, goal setting and BP and weight monitoring. 37
Control Group Usual care Clinic visits as prescribed usually every 2-3 months. 6 months The participants continued with clinic visits to the primary health care facility as prescribed by the physicians 31 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with high BP (systolic ≥140 mmHg and/or diastolic ≥90 mmHg measured on at least 2 separate screening measurements) Aged 18 years and above Receiving primary care from the selected level 3 primary health facilities Available to be followed up for 6 months. Elderly hypertensive patients aged above 70 years Hypertensive patients already on hypertension follow-up and management elsewhere or wished to relocate from the study area during the study period. Adult: 19 Year-44 Year,Aged: 65+ Year(s) 18 Year(s) 70 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 30/06/2022 Jomo Kenyatta University of Agriculture and Technology Institutional scientific and ethical review committee
Ethics Committee Address
Street address City Postal code Country
Juja Nairobi 62000 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Differences in systolic and diastolic BP (SBP and DBP respectively) changes from baseline to the 6 month follow-up 0, 3 and 6 months
Secondary Outcome Proportion of patients with controlled hypertension, body composition – body mass index and waist height ratio 0, 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ruiru primary health facility Thika road Nairobi Kenya
Juja primary health care facility Juja road Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Consortium for advanced training in Africa Kitisuru, Nairobi Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor African population health research Kitusuru Road Nairobi Kenya University
Primary Sponsor Consortium for advanced training in Africa Kitusuru Road Nairobi Kenya Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Patrick Mburugu ethics@jkuat.ac.ke +25406758700001 Juja Nairobi
City Postal code Country Position/Affiliation
Nairobi 62000 Kenya Chairperson Jkuat ERC
Role Name Email Phone Street address
Principal Investigator Grace Mbuthia grace.mbuthia@jkuat.ac.ke +254722287196 Juja Nairobi
City Postal code Country Position/Affiliation
62000 Kenya CARTA Postdoctoral fellow
Role Name Email Phone Street address
Public Enquiries Eucabeth Majiwa ethics@jkuat.ac.ke +2506758700001 Juja Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya Secretary IREC Jkuat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be shared with anyone who wishes to access the data immediately following publication. The deidentified data will be shared with the journal publisher and will be publicly available. Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD will be available for sharing from 31st December 2023 to 1st June 2023 and availability will have no end date.. Data from this study are available from the approving ethics committee (Jomo Kenyatta University of Agriculture and Technology institutional scientific and ethical review committee) upon written requests under the ethical provisions of the body. To access data, one can write to the chair, Institutional Scientific and Ethical Review Committee (ISERC), Jomo Kenyatta University of Agriculture and Technology, P.O. Box. 62000-00200 Nairobi, Kenya (Office line: +254-067-58700001; e-mail ethics@jkuat.ac.ke).
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