Measuring blood pressure and cardiovascular risk in rural Kenya and The Gambia
| ISRCTN | ISRCTN35951727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35951727 |
- Submission date
- 23/02/2024
- Registration date
- 27/02/2024
- Last edited
- 27/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Many people live with high blood pressure in sub-Saharan Africa. In this region, the proportion of people with high blood pressure is one of the highest in the world. However, few people with high blood pressure are treated and this can lead to serious medical issues and even death. This is particularly true in rural areas where treatment and understanding of blood pressure is lower than in cities.
There are many reasons why high blood pressure is a major health problem in rural sub-Saharan Africa, such as a lack of clear symptoms; less access to healthcare; and limited time to travel to clinics for care. One option for improving the management of blood pressure is to use a community-centred approach, where care is brought into the community making it easier to access.
To bring care into the community, we need to find out what is the best way for community health workers to identify who needs to be treated. Standard techniques may not be useful in a rural community and could require too many resources to make them practical. This study aims to determine what is the best way to identify high blood pressure and related health complications in a community setting.
Who can participate?
The study will take place across two sites: one in Kilifi, Kenya and the other in Kiang West, The Gambia. We will enrol 1250 participants, aged 30 years or older, with 625 in each country.
What does the study involve?
Participants who join the study will complete a series of short questionnaires about their general health status. They will then receive 4 different blood pressure measurements over a two-week period. These include a home-based measurement (twice daily for seven days), unattended and attended measurement (once each for 15 minutes) and a 24-hour measurement (the participants will wear a cuff for 24 hours). The blood pressure measurements will be conducted in a different order for each participant. Following the blood pressure measurements, the participants will attend their local clinical facility for tests to determine if they have any organ damage caused by high blood pressure. The tests will look at your heart, eyes, kidneys, and blood vessels. A single blood draw is required. These tests will require two visits from the participant to the clinic facility. Any relevant findings will be reported back to the participant. After this, participants have completed their involvement in the study.
What are the possible benefits and risks of participating?
Benefits. Participants will have their blood pressure measured and be told whether they have high blood pressure. In addition, participants will be able to find out whether the high blood pressure has affected their organs. After the study, those with high blood pressure will be referred to the appropriate clinics for further care. There is a benefit to society by helping us find the best ways to measure blood pressure and associated organ damage.
Risks: The overall risk profile of this study is very low. Minor risks involved in participating in this study include loss of time completing blood pressure assessments and questionnaires. Additionally, when invited to the hospital for further tests, participants will spend time travelling to the hospital and having the measurements. Participants will be compensated for their travel costs. Finally, there is risk of pain, redness, swelling or infection at the site of the blood draw.
Where is the study run from?
London School of Hygiene & Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
August 2022 to January 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
ihcor_africa@lshtm.ac.uk
Contact information
Public, Scientific
London School of Hygiene & Tropical Medicine, Keppel Street
London
WC1E7HT
United Kingdom
 ORCID ID |
0000-0002-9817-2390 |
|---|---|
| Phone | +44 20 7927 2723 |
| IHCoR_Africa@LSHTM.ac.uk |
Principal Investigator
London School of Hygiene & Tropical Medicine, Keppel Street
London
WC1E7HT
United Kingdom
| Phone | +44 20 7927 2723 |
|---|---|
| IHCoR_Africa@LSHTM.ac.uk |
Principal Investigator
KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine
Kilifi
P.O. Box 230-80108
Kenya
| Phone | +44 20 7927 2723 |
|---|---|
| IHCoR_Africa@LSHTM.ac.uk |
Study information
| Study design | Multicentre cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community |
| Study type | Diagnostic, Prevention, Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Determining the optimal diagnostic and risk stratification approaches for people with hypertension in two rural populations in Kenya and The Gambia |
| Study acronym | IHCoR-Africa WP2 |
| Study hypothesis | Sub-Saharan Africa (SSA) has one of the highest prevalences of hypertension worldwide. The impact of hypertension is of particular concern in rural SSA, where access to clinics and hospitals is limited. Improvements in the management of people with hypertension in rural SSA could be achieved by shifting diagnosis and care from the clinic to the community. To develop such a community-centred programme we need optimal approaches to identify and risk stratify patients with elevated blood pressure. The aim of the study is to improve the evidence base for diagnosis and risk estimation for a community-centred hypertension programme in two rural settings in SSA. |
| Ethics approval(s) |
1. Approved 06/03/2023, London School of Hygiene & Tropical Medicine Ethics Committee (Keppel Street, London, WC1E 7HT, United Kingdom; +44 20 7927 2723; ethics@LSHTM.ac.uk), ref: 28276 2. Approved 06/02/2023, KEMRI Scientific & Ethics Review Unit (Center for Geographic Medicine Research, Coast, Kilifi, P.O. Box 230-80108, Kenya; +254 020 2722541; ddrt@kemri.go.ke), ref: KEMRI/SERU/CGMR-C/277/4620 3. Approved 06/03/2023, MRC the Gambia Ethics Committee (Atlantic Boulevard, Fajara, PO Box 273, Gambia; +220 44954426 Ext 2308; ethics@mrc.gm), ref: 28276 |
| Condition | Hypertension |
| Intervention | Participants will be identified through demographic surveillance systems and approached to participate. Those who consent will be entered into the study. Participants will have their blood pressure measured in four different ways over two weeks. These assessments include: 1. Attended and unattended Automated Blood Pressure Measurements (aABPM and uABPM), which take 10-15 minutes to conduct, will be performed at the homes of study participants 2. Home-based Blood Pressure Measurement (HBPM) which consist of morning and evening measurements performed by the individual participant for 7 days in a row 3. 24-hour ambulatory BP measurement (24-hr-ABPM) which requires participants to wear a blood pressure monitor for 24-hours. After the blood pressure measurements, participants will be invited for two clinic visits to assess the impact of the hypertension on their heart, eyes, kidneys and blood vessels. They will receive electrocardiograms, echocardiography, blood tests, and diagnostic imaging of their retina. At these visits information will be collected on demographics, household assets, anthropometrics, diet, physical activity, history of hypertension and medication use. After the clinic visits, participants will be discharged from the study. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omron 907, Omron m7 Intelli, Omron 24/7, Spacelabs 24 hour ABPM, Abbott iStat, Remidio FOP-NM10, Alivecor KardiaMobile 6L, and Tendiomed Arteriograph 24. |
| Primary outcome measure | Measured at baseline: 1. Blood pressure measured by 24-hr ABPM, HBPM, and u/aABPM. 2. Left ventricular hypertrophy measured by transthoracic echocardiogram, 12-lead electrocardiogram and smartphone based 6-lead ECG 3. Left ventricular systolic dysfunction assessed transthoracic echocardiogram, and smartphone based 6-lead ECG 4. Hypertensive retinopathy measured using clinical grade retinal camera and smartphone-based portable retinal cameras 5. Renal dysfunction measured using clinical laboratories and point-of-care clinical chemistry devices 6. Arterial stiffness measured using blood-pressure cuff assessment of pressure wave velocity |
| Secondary outcome measures | 1. Cardiovascular risk factors assessed using questionnaire at baseline 2. Participant demographics assessed using questionnaire at baseline |
| Overall study start date | 01/08/2022 |
| Overall study end date | 31/01/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | 1250 |
| Participant inclusion criteria | 1. Registered in population registers of the KWHDSS (The Gambia) or KHDSS (Kenya) 2. Aged ≥30 years at the time of enrolment in the study 3. Able to provide written informed consent to participate in the study |
| Participant exclusion criteria | Pregnant women (self-reported) |
| Recruitment start date | 01/07/2023 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- Gambia
- Kenya
Study participating centres
Kilifi
P.O. Box 230-80108
Kenya
Fajara
PO Box 273
Gambia
Sponsor information
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 20 7636 8636 |
|---|---|
| ethics@LSHTM.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | One of the main strengths of IHCoR-Africa is the strong engagement with the community and key stakeholders. The research team has secured support from governmental organizations, civil society, scientific societies, health care providers, and patient groups. Their active engagement in IHCoR-Africa activities before and during the study will be our first step to ensuring early engagement and targeted dissemination of the results. We will present study outputs in scientific meetings of our partners including PASCAR, KCS and AESA and seminars run by the partner institutions. The IHCoR-Africa website, provides up-to-date information on the progress of the study. A formal communication and impact strategy will be developed with the support of the communication departments of participating institutions. Publications produced from IHCoR-Africa will be open-access in accordance with NIHR policy. A publication policy will be agreed by all members of the IHCoR-Africa team prior to the first paper being published. |
| IPD sharing plan | When the results of this study are prepared and published, anonymised data will be made available in line with the policies of the NIHR, LSHTM, KWTRP and MRCG. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 25/01/2023 | 27/02/2024 | No | No |
Additional files
Editorial Notes
23/02/2024: Trial's existence confirmed by London School of Hygiene & Tropical Medicine Ethics Committee.
