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.: PACTR202003783697033 Date of Approval: 30/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating a service model for management of hypertension and diabetes among low and middle- income patients enrolled on M-TIBA in Kenya
Official scientific title Evaluating a service model for management of hypertension and diabetes among low and middle- income patients enrolled on M-TIBA in Kenya
Brief summary describing the background and objectives of the trial Both hypertension (HTN) and diabetes represent two major risk factors for atherosclerotic cardiovascular diseases (CVD), the number one cause of death globally. Despite the clear evidence that lowering blood pressure (BP) and blood sugar through lifestyle changes and drug treatment can greatly reduce the risk of CVD), HTN-control (defined as the proportion of people who reach their target for BP lowering) and diabetes control (defined as HbA1c<7%) is still poor. This study aims to develop, implement and evaluate a technologically driven model that improves access to care and self-management of hypertension and diabetes at home
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial A behavioural intervention using SMS for self-monitoring of blood pressure and blood glucose at home
Anticipated trial start date 13/01/2020
Actual trial start date
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 406
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BP device plus behavior intervention A Daily 12 months Hypertensive patients in Group A will receive the BP device plus daily SMS to measure their BP daily 94
Experimental Group BP device plus behavior intervention B Weekly 12 months Hypertensive patients in intervention Group B will receive the BP device plus a behavioral intervention (weekly SMS) to measure their BP weekly. 94
Control Group BP device no behavior intervention C Patient's own discretion 12 months Hypertensive Group C (control group) will receive the BP device with no behavioral intervention and measure their BP at their own discretion. 94 Dose Comparison
Experimental Group Glucometer device plus behavior intervention Weekly 12 months Diabetic patients in the intervention group will receive the glucometer device plus a behavioral intervention (weekly SMS) to measure their blood sugar weekly 62
Control Group Glucometer device but no behavior intervention At the patient's own discretion 12 months Diabetic patients in the control group will receive a glucometer device but no behavioral intervention and will measure their blood sugar at their own discretion. 62 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with a new diagnosis of essential HTN or diagnosed with type 2 diabetes 2. Patients known to have essential HTN or with diabetes who are already receiving medication. 3. HTN- or diabetic patients receiving treatment provided by the recruiting site 4. Adult (> 18 years old) 5. Ownership of a phone 6. Patients paying out of pocket and willing to be enrolled on M-TIBA 1. Patients with (suspected) secondary HTN, as described by local guidelines. This diagnosis is at discretion of the treating physician 2. HTN-patients requiring treatment (secondary, tertiary HTN care) not provided by the recruiting site 3. Patients unwilling or who refuse to give informed consent 4. Arm circumference greater than or less than the 22-42 cm for which the used cuffs is validated 5. Failure to obtain valid BP-values (e.g. cardiac arrhythmias) 6. Pregnancy 7. Patients who are judged to be unsuitable for receipt of mobile HTN or diabetes care by the treating physicians (for instance, patients with life-threatening diseases, dementia, and illiterate patients). 8. Patients who have had an acute cardiovascular event in the previous 3 months. 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) 99 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 10/07/2019 African Medical Research Foundation
Ethics Committee Address
Street address City Postal code Country
P.O Box 30125 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean change in systolic blood pressure Baseline, 6 months, 12 months
Primary Outcome Mean change in diastolic blood pressure Baseline, 6 months, 12 months
Primary Outcome Mean change in fasting blood sugar/HbA1c<7% Baseline, 6 months, 12 months
Secondary Outcome Frequency of measuring blood pressure As measured
Secondary Outcome Frequency of measuring blood sugar As measured
Secondary Outcome Cost-effectiveness of the intervention Continuously during the course of the trial
Secondary Outcome Acceptability of the intervention by patients During the course of the trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Access Afya kwa Njenga clinic Mukuru kwa Njenga Nairobi Kenya
Access Afya Taasia Clinic Taasia Nairobi Kenya
Limuru Nursing Home Limuru Limuru Kenya
St Johns Hospital Along Thika Road, Kasarani Mwiki Way Nairobi Kenya
Coptic Mission Hospital Ngong Road, Opposite China Centre Nairobi Kenya
Melchizedek Hospital Naivasha Road Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Sanofi 54 Rue la Boetie Paris France
Boehringer Ingelheim Binger Str. 173 Ingelheim am Rhein Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sanofi 54, Rue La Boetie Paris France Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Catherine Kyobutungi African Population and Health Research Center, P.O Box 10787 Nairobi 00100 Kenya
Gershim Asiki African Population and Health Research Center, P.O. Box 10787 Nairobi 00100 Kenya
Hermann Pythagore Pierre Donfouet African Population and Health Research Center, P.O. Box 10787 Nairobi 00100 Kenya
Caroline Wainaina African Population and Health Research Center, P.O. Box 10787 Nairobi 00100 Kenya
Peter Otieno African Population and Health Research Center, P.O. Box 10787 Nairobi 00100 Kenya
Calistus Wilunda African Population and Health Research Center, P.O. Box 10787 Nairobi 00100 Kenya
Marleen Hendriks Joep Lange Institute, Paasheuvelweg 25, 1105 BP Amsterdam Netherlands
Judith Van Andel Joep Lange Institute, Paasheuvelweg 25, 1105 BP Amsterdam Netherlands
Angela Siteyi Pharmaccess Foundation Kenya, P.O. Box 6711 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Catherine Kyobutungi ckyobutungi@aphrc.org +25420400100 P.O. Box 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Executive Director African Population and Health Research Center
Role Name Email Phone Street address
Scientific Enquiries Gershim Asiki gasiki@aphrc.org +254204001000 P.O. Box 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Scientist African Population and Health Research Center
Role Name Email Phone Street address
Public Enquiries Gershim Asiki gasiki@aphrc.org +254204001000 P.O Box 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Scientist African Population and Health Research Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified patient data and data dictionary Summary results Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Six months after the end of data collection (after June 2021) Data will be made available to eligible users in line with APHRC data sharing policy available through the link provided below.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://microdata.aphrc.org/downloads/APHRC_GUIDELINES_ON_DATA_ACCESS_AND_SHARING.pdf 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