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.: PACTR202408912454189 Date of Approval: 12/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Home Blood Pressure Telemonitoring on hypertension control rate and drug adherence in Kenya: an interventional study (HBPT-K)
Official scientific title Effect of Home Blood Pressure Telemonitoring on hypertension control rate and drug adherence in Kenya: an interventional study (HBPT-K)
Brief summary describing the background and objectives of the trial Background Cardiovascular Diseases (CVDs) are the fourth leading cause of death in Kenya. Hypertension is the most significant risk factor for CVDs globally. The rates of hypertension control and drug adherence are low in Kenya. Home Blood Pressure Telemonitoring (HBPT) coupled with Personal Counselling Programs (PCP) has been proposed as a new method to improve blood pressure control and adherence to treatment. A nationwide survey conducted in 2015 in Kenya found 24% of Kenyans between 18-69 years to have hypertension. Only 22% of these patients were on treatment with only 50% having a controlled blood pressure (BP) [1] . The proposed study will collect important new evidence for cardiovascular risk management, specifically for hypertension. If HBPT in the study population proves to be effective in terms of improving adherence to treatment, guideline adherence and blood pressure control, it could serve as a step towards improving blood pressure control on a larger scale in Kenya. Objectives The aim of this study will be to investigate effects of HBPT and PCP on hypertension control rate and drug adherence. In addition, the study will also determine the effects of HBPT compared with usual care on patient and healthcare worker satisfaction.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 29/03/2024
Actual trial start date 29/03/2024
Anticipated date of last follow up 29/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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
Single Group Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Home Blood Pressure Telemonitoring None 6 months After gaining written informed consent, patients will receive an Omron HEM-9210T blood pressure monitor. This monitor is a CE-marked home blood pressure monitor. They will also have the Luscii app installed on their smartphone and will be registered with the Luscii program. They will enroll in the hypertension blood pressure protocol which was developed together with four large teaching hospitals in the Netherlands. This protocol was further adapted to local requirements. Baseline demographic data will be obtained and once the patient is discharged from the clinic, they will start HBPT. The frequency of measurements (weekly, one week every two weeks, or one week a month) will depend on the blood pressure target set by the treating clinician. At baseline we will assess drug adherence by means of the MARS-5 scale. We will assess adherence to the Kenya national guidelines based on the number of antihypertensive drugs a patient is currently taking and whether these prescriptions are in line with the guidelines. Patients will be treated with HBPT for 6 months. After 6 months patients will present themselves again for a study visit. Routine clinic visits will continue during the study (for example to collect new drug prescriptions). During the 6-month study visits, they will have their blood pressure measured according to the SPRINT protocol. They will be asked to fill in two questionnaires, i.e. TUQ and MAUQ, to evaluate patient satisfaction and to fill in the MARS-5 scale again. A note will be made of the antihypertensive drugs used during the study and whether these are in line with the Kenya national guidelines. The study will terminate after the 6-months follow up visit. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age ≥18 years - Confirmed hypertension with BP>140/90 mmHg - Own or have access to a smartphone with internet access throughout the study period - Able to provide written informed consent prior to participation in the study - Persistent atrial fibrillation as indicated in the health record - Pregnant or planning to become pregnant during the study period - Severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e., hemodialysis or peritoneal dialysis) - Recent cardiovascular event (ischemic stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months - Diagnosis of dementia or psychosis as indicated in the health record - Life expectancy <1 year, for instance in terminal cancer or NYHA III or IV heart failure - Individuals requiring BP monitor cuff size larger than 42cm Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 04/01/2024 Kenyatta National Hospital University of Nairobi
Ethics Committee Address
Street address City Postal code Country
Hospital road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HBPT will improve hypertension control rates (% below <140/90mmHg, as measured by the SPRINT protocol) at 6 months as compared with historical nationwide hypertension control rates. 6 months
Secondary Outcome HBPT will improve drug adherence (as measured with the MARS-5 tool) as compared with historical nationwide drug adherence data. 6 months
Secondary Outcome Digital application of Kenya’s national cardiovascular disease guidelines will lead to improved guideline adherence as measure by ‘guideline-based prescriptions’ compared with baseline. 6 months
Secondary Outcome Patient satisfaction in the HBPT program will be high based on TUQ and MAUQ questionnaires (overall median >5, scale 1 to 7) 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mwai Kibaki Hospital Othaya- Nyeri road Nairobi 10106 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Luscii App Nicolaas Beetsstraat 216 3511HG Utrecht The Netherlands Utrecht Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Luscii App Nicolaas Beetsstraat 216 3511HG Utrecht The Netherlands Utrecht Netherlands Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Kenya Cardiac Society Firth Ngong Avenue road Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernard Samia bernardsamia@gmail.com +254722829620 Firth Avenue Ngong road
City Postal code Country Position/Affiliation
Nairobi Kenya President Kenya Cardiac Society
Role Name Email Phone Street address
Public Enquiries Kennedy Okinda okindao16@gmail.com +254719200139 Othaya Nyeri road
City Postal code Country Position/Affiliation
Nairobi Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Job Steenkiste jobvansteekiste@gmail.com +31631799089 Nicolaas Beetsstraat 216 3511HG Utrecht The Netherlands
City Postal code Country Position/Affiliation
Utrecht Netherlands Luscii App
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Beginning 9 months and ending 36 months following article publication Clinical Study Report,Study Protocol 9 months and ending 36 months following article publication Publication journal
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