{"doc_desc":{"title":"Ngao Ya Afrya","idno":"DDI-KEN-APHRC-NgaoYaAfia-2018-v10","producers":[{"name":"African Population and Health Research Center","abbreviation":"APHRC","affiliation":"APHRC","role":"Documentation of the DDI"}],"prod_date":"2025-03-11","version_statement":{"version":"Version 1.0 ( March 2025)"}},"study_desc":{"title_statement":{"idno":"DDI-KEN-APHRC-NgaoYaAfia-2018-v10","title":"Evaluating a service model for management of hypertension and diabetes among low- and middle income patients enrolled on M-TIBA in Nairobi, Kenya","sub_title":"Ngao Ya Afya","alt_title":"Ngao Ya Afya"},"authoring_entity":[{"name":"Catherine Kyobutungi, PhD","affiliation":"African Population and Health Reserch Center (APHRC)"}],"production_statement":{"producers":[{"name":"Gershim Asiki, PhD","affiliation":"African Population and Health Research Center","role":"Co-Principal Investigator"},{"name":"Herrmann Dounfet, PhD","affiliation":"African Population and Health Research Center","role":"Co-Principal Investigator"},{"name":"Peter Otieno MPH","affiliation":"African Population and Health Research Center","role":"Co-Investigator"},{"name":"Bonface Ingumba","affiliation":"African Population and Health Research Center","role":"Data Governance Officer"}],"copyright":"Copyright \u00a9 APHRC, 2025","funding_agencies":[{"name":"Sanofi through PharmAccess","abbreviation":"","role":"Funder"},{"name":"Boehringer Ingelheim through PharmAccess Boehringer Ingelheim through PharmAccess Boehringer Ingelheim through PharmAccess Boehringer Ingelheim through PharmAccess","abbreviation":"","role":"Funder"}]},"series_statement":{"series_name":"Demographic and Health Survey [hh\/dhs]","series_info":"N\/A"},"version_statement":{"version_date":"2025-03-11","version_notes":"N\/A"},"study_info":{"abstract":"Abstract\nBackground: Both hypertension (HTN) and diabetes represent two major risk factors for \natherosclerotic cardiovascular diseases (CVD), the number one cause of death globally1\n. Despite the \nclear evidence that lowering blood pressure (BP) and blood sugar through lifestyle changes and drug \ntreatment can greatly reduce the risk of CVD), HTN-control (defined as the proportion of people who \nreach their target for BP lowering) and diabetes control (defined as HbA1c<7%) is still poor. \nObjective: aim to develop, implement and evaluate a model that improves BP and blood sugar control \nfor patients and streamlines and partly finances the provision of hypertension and diabetes care for \nhealthcare providers while potentially reducing cost and improving access to quality care\nMethodology: The core of the model is the interaction between M-TIBA (a mobile health platform for \nfinancial inclusion in healthcare that enables people to save, send, receive and pay money for medical \ntreatment through a mobile health wallet on their phone) and mobile phone application (Afya-pap)\nfor patients and a patient tracker for healthcare providers, which will improve access and allow for \nhome-based measuring and monitoring of BP and blood sugar in both low and middle socio economic \nstatus populations in Nairobi, Kenya. The project will test the acceptability of the mobile application \nand feasibility of integrating the mHealth model into clinical care, including the effectiveness in \ncontrolling BP and blood sugar respectively when patients receive regular text messages encouraging \nthem to take measurments at home or using a mini-tracker calendar. For the text messaging \nbehavioural intervention patients will be randomized to reminders on blood pressure measurements \nin three arms (daily, weekly and no messages), and two arms for blood sugar measurments (weekly \nand no messages). Three surveys (baseline, midline and endline-6 months apart) will be conducted to \nestimate the proportion of patients with blood pressure and blood sugar controlled. The mini-tracker \nbehavioural intervention will be conducted among patients and evaluated through one-group prepost design. Cost-effectiveness of the intervention will also be evaluated. \nDuration and budget: The project will be undertaken for 2 years. Interviews will be conducted with \nhealthcare providers and the patients. The total budget will be 151,688 USD \nConclusion: The outcomes of this project will inform the integration of the mHealth based service \nmodel into the daily routine of the participating clinics. This generation of real-time clinical data, will \nensure easy translation into clinical practice, and will facilitate rapid scale-up.","coll_dates":[{"start":"2018-09-17","end":"2020-09-15","cycle":""}],"nation":[{"name":"Kenya","abbreviation":"KEN"}],"geog_coverage":"National ( Nairobi low and middle income)","analysis_unit":"-Hypertension and Diabetes patients \n-Doctors\n- Phrmacy staff","universe":"Patients of Hypertension and Diabetes in low and middle socio economic parts of Nairobi","notes":"The scope of the study includes;  Introduction, Actions in response to COVID-19, Household impact of COVID-19, Tobacco and Alcohol use, Dietary diversity, Physical activity, Clinic visits, Occupaational costs, Satisfaction with care & adherence, Underlying conditions, Treatment burden, Anthropometric measurements and blood preasure measurements for pregnant women","study_scope":"The scope of the study includes;  Introduction, Actions in response to COVID-19, Household impact of COVID-19, Tobacco and Alcohol use, Dietary diversity, Physical activity, Clinic visits, Occupaational costs, Satisfaction with care & adherence, Underlying conditions, Treatment burden, Anthropometric measurements and blood preasure measurements for pregnant women"},"method":{"data_collection":{"sampling_procedure":"This will be a prospective cohort study with a pre-post design. It will be divided into two phases:\n(i) Pilot phase \nThis will involve recruitment of patients on Afyapap and each patient followed for four months to \nassess the acceptability of and feasibility of using the service module and home based management \nof hypertension or diabetes. Within the cohort, we aim to test patient retention in care as primary \noutcome. However, secondary outcomes include the optimal frequency of home blood-pressure \nmeasurements and uptake of the behavioral intervention and patient satisfaction with the use of the \napplications. This pilot group will receive BP devices plus behavior intervention and measure their BP \ndaily (to be recruited in October 2018) and followed for four months. Depending on the lessons learnt \non the feasibility of scaling up, this group could be followed for one year. The lessons learnt from the \npilotwill provide insights into the scale up phase.\nThe patients will be screened for eligibility (the inclusion and exclusion criteria is outlined above). The \nreasons that patients are not eligible will be recorded. If patients are eligible, they will be asked to \nparticipate in the study. If patients are eligible and unwilling to participate in the study, they will be \nasked to fill out a short quantitative questionnaire describing their reasons for not participating, they \nwill however not be forced to fill in the questionnaire. In the pilot phase, 500 eligible patients with \nhypertension or diabetes will be enrolled consecutively on to AFya pap and will be asked to monitor \ntheir BP daily or fasting blood sugar weekly if they have diabetes. This arm also contains a behavioral \nintervention in the form of reminders to measure their BP prior to each prescribed measurement and \nis treated as a pilot arm to examine the feasibility of the study procedures in the first 4 months. \n11\nWe additionally propose to pilot a behavioural intervention that entails using a mini-tracker by \npatients enrolled on Afyapap. The mini-tracker is a card including a small calendar, instructions on \nhow to enter measurements into Afya Pap in the USSD platform, and a goal chart where patients can \nindicate their BP or blood glucose goal for the end of the month. The calendar will display one month\u2019s \nworth of days and times for which patients can indicate their measurement results after each reading. \nEvery month new cards will be issued through patient group leaders while cards of their previous \nmonths are returned. Patients will also receive various reminders to measure, based on their chosen \nday and time of measuring during the onboarding phase. To determine the most effective source of \nmessages on measurement adherence, we will provide reminders coming from their preferred clinic, \ntheir patient group leader, their chosen physician, or a family member of their choice. These more \npersonalized messages serve to increase the patient\u2019s motivation to continue monitoring their blood \npressure and\/or blood sugar levels and to engage with the Afya pap platform. \nPatients will also be assigned a patient group based on their geographic location. These groups exist \nto provide support to each patient through group discussions of chronic disease management, \npractice and information on measuring their BP or blood sugar, and social support through other \npatient members dealing with either HTN or Diabetes. We anticipate including approximately 1,000 \nAfya Pap users who are not receiving the SMS intervention and each will be followed for 6 months to \ntest these iterations of the tracker. Based on previous research with providing calendars to help new \nor expectant mothers save for health insurance, we postulate that the tracker will provide a similar \nfunction for Afya Pap users and can be accomplished at a reduced cost compared to providing full \nannual calendars. \n(ii) Scale up phase\nAfter the learning from the pilot phase of 4 months, the subsequent enrolments will be randomized \nto two armsin the ratio of 1:1. Thepatients will be randomly assigned to 2 groups defined by frequency\nof measuring BP or blood sugar and the presence or absence of behavioral interventions. The study \ndesign is outlined in figures 2 and 3. In arm A, patients with hypertension or diabetes will be asked to \nmonitor their BP or blood sugar weekly using a BP device or glucometer provided to them by the study \nteam and will enter the measurements on afyapap. Patients with diabetes using smartphones will be \nprovided with glucometers that are connected by a device that automatically relays blood sugar \nreadings to the smartphone. Those with non-smartphones (feature phones) will use a USSD code to \nactivate Afyapap and enter blood sugar mearurements manually. Arm A has behavioral intervention\nin the form of weekly SMS remiders to increase adherence to BP or blood glucose measurements. In \narm B devices will also be provided for measurement of BP and blood sugar at home, however the \nparticpants will choose when to take the measurements. There will be no SMS reminders to the \nparticipants.\n12\nStudy population \nThe study population will be lower income and middle income adult patients with HTN or diabetes or \nboth, recruited from selected health facilities: divided into the two arms of the intervention. The \npatients will be selected based on the inclusion and exclusion criteria outlined before. \nDescription of the steps in enrolment and follow up.\nFollowing randomization to one of the two study arms, day 0 of the study starts with a baseline study \nassessment and onboarding of the patient on M-TIBA and in the self-management application. \nHealthcare providers or a study nurse will assist patients with installing the application on their smart \nphone, and instruct them in its use. During the patient set-up in the application, patients will complete \na personal profile that allows for tailoring of the behavioral intervention. \nPatients will then receive training in the use of a home based BP or blood sugar monitoring device.\nPatients will be instructed to perform weekly BP measurements (or more, if national guidelines \nprescribe more frequent monitoring). Once at home and using the BP monitor, patients will enter their \nmeasurement results in the application. We will set up protocols for extreme BP and blood sugar\nvalues based on best practice and national guidelines. \nStudy setting\nThe study will take place in health care clinics servicing the low and middle- income populations in \nNairobi, Kiambu and Vihiga Counties in Kenya. The choice of this population is based the challenges \nof affording care and inability to enrol in private health insurance. But the patient population included \nwill be those patients who have some means to afford HTN or diabetes treatment or who are not \ninsured whose access can be enhanced through the financing model and home based management. \nThere will be selected health facilities from Nairobi, Kiambu and Vihiga Counties in Kenya where \npatients will be enrolled from. The health facilities are; Langata hospital, Access Afya kwa Njenga clinic, \nAccess Afya Taasia Clinic, Limuru Nursing Home, Kalimoni Mission Hospital, Coptic Mission Hospital, \nKima Mission Hospital, Jumuia Friends Kamusinga Hospital, Mungoma Hospital and St. Marys hospital. \nIn the event that we will not be able to get the required sample in the nine health facilities, we will \nrecruit more facilities. These facilities are purposely selected because they have patient populations \nof interest to the study, as informed by the experiences of PHARMACCESS. Currently, PharmAcces is \nrolling out the service model for management and financing hypeternsion in three counties (Nairobi, \nKiambu and Vihiga) targeting approximately 4000 patients in total. Permission will also be sought from \nrelevant authorities including local authorities, county and sub-county to allow entry into the selected \nhealth facilities in Nairobi, Kiambu and Vihiga counties. The evaluation will be conducted in a \nrepresentative sample as shown below.\nSample size calculation and recruitment\nSample size for patients with hypertension\nFrom Van De Vijver et al. 10 \u2019s study, we estimate that among people who are in treatment, 50% were \nable to achieve glycemic control. We assume that the current intervention will increase the BP control \nby 20% in one year of follow-up. Thus, we posit a 20% meaningful difference, and 80% power with 5% \nlevel of significance (one-sided test) to detect that difference. Since our study design is a pre-post \ndesign, we estimate the sample size following Connor\u2019s study 64. The conservative necessary sample \n13\nsize is 75 hypertensive patients per study arm. Furthermore, we assume a dropout rate of 20%, \nimplying that the final sample size is 94 hypertensive patients to be recruited at the pre-intervention \nphase (baseline), and 94 hypertensive patients to be surveyed at the post-intervention phase (midline \nand end line) in each of the 3 selected counties. Hence for baseline, midline and end line, the total \nsample size required for patients with HTN is 282 (94\u00d73) respondents at each time point. When it is \nnot feasible to recruit the minimum number from a particular county, we will oversample in the other \ncounties to achieve the required total sample.\nFigure 2 represents the survey design and distribution of patients by study arm in each county\nFigure 2 represents the survey design and distribution of hypertensive patients by study arm. Group \nA will receive the BP device plus behavior intervention and measure their BP daily (to be recruited \nfrom January 2019- scale up phase) and each patient followed for one year.\nGroup B will receive the BP device plus behavior intervention and measure their BP weekly (to be \nrecruited from January 2019- scale up phase) and each patient followed for one year. Group C will \nreceive the BP device no behavior intervention and measure their BP at their discretion (to be \nrecruited from January 2019- scale up phase) and each patient followed for one year.\n\nSample size and recruitment of patients with diabetes \nIn reference to a study by Otieno C et al.,22 we estimate that among patients with diabetes who are in \ntreatment, 30% were able to achieve glycemic control. We assume that the current intervention will \nincrease the BP control by 30% in one year of follow-up based on findings from a randomized control\ntrial in 3 Low and Middle Income countries including Democratic Republic of Congo65. Thus, we posit \na 30% meaningful difference, and 80% power with 5% level of significance (one-sided test) to detect \nthat difference. Since our study design is a pre-post design, we estimate the sample size of 49 patients \nwith diabetes per study arm. Furthermore, we assume a dropout rate of 20%, implying at baseline, \nmidline and end line survey, 62 patients with diabetes wil be enrolled in each arm, a total 124 (62X2)\nin each of the 3 counties at baseline, midline and endline surveys respectively. In the event that we \ncan not get the minimum number of patients in a particular county, we will oversample in the other \ncounties to achieve the total number required per survey round. \nFigure 3 represents the survey design and distribution of diabetic patients by study arm. Group A will \nreceive the glucometer device plus behavior intervention and measure their blood sugar weekly (to \nbe recruited from January 2019- scale up phase) and each patient followed for one year. Group B will \nreceive the glucometer device no behavior intervention and measure their blood sugar at their \ndiscretion (to be recruited from January 2019-scale up phase) and each patient followed for one year.","sampling_deviation":"N\/A","coll_mode":"Face-to-face [f2f]","research_instrument":"Digital questionnaire with following data: \ndemographics (age, sex), education, income, ethnicity, use of alcohol, smoking status, other CVD risk \nfactors (physical inactivity and unhealthy diet), hours absence from work, travel costs to the clinic, \nadherence to drugs and medication adherence percentage (for patients already on treatment); data \nextraction from electronic health record if not available through digital questionnaire: co-morbidities, \ndrug use (type, number of drugs, frequency), already receiving HTN care and physical examination \ndone by the study nurse: height, weight, waist circumference, arm circumference, hip circumference, \netc. \n\n\nIn-depth interviews and focus group discussions (FGDs) with purposively \nselected providers and a subset of the patients (those with the highest quartile of adherence to blood \npressure or blood sugar and the lowest quartile of adherence) provided information on provider \nand patient experiences with the application.","act_min":"Data collection was supervised by carefully trained team leaders and the research team. During fieldwork, data quality was enhanced by APHRC team leads through regular spot checks and sit-ins to approximately 5-10% of each field worker's daily work to verify authenyicity of the data collected. The field supervisor certified the quality of the data through editing of the data before they were transfered to the database.","weight":"N\/A","cleaning_operations":"Qualitative data were recorded and transcribed. Transcribed data was saved in word format and \nsaved in a password protected computer for storage, audio-taped interviews werel also labeled with \nthe study identifier, rather than with names. The quantitative data collected through surveys at \nrecruitment and during the research contained unique numbers for each patient, the data was \ncollected by the health facility staff and analyzed by the research team. All study participants in this \nresearch were assigned unique study identifiers by the health facility to protect patient data \nconfidentiality. The data will be accessible to both APHRC and the health facilities. The data has been\nstored in a computerized database and all study documentation and materials (including informed \nconsent forms) stored in locked file cabinets when not in use at APHRC. Only project and \nassigned healthcare staff had access to the data. \nAnonymized and aggregated data-insights were shared with the pharma-partner involved in this \nproject, of which the project-management team is partly based in Kenya and partly based in France.","method_notes":"N\/A"},"analysis_info":{"response_rate":"N\/A","sampling_error_estimates":"N\/A"}},"data_access":{"dataset_use":{"contact":[{"name":"African Population and Health Research Center","affiliation":"APHRC","email":"datarequest@aphrc.org","uri":"www.aphrcmicrodataprtal.org"}],"cit_req":"Use of the dataset must be acknowledged using a citation which would include:\n- the Identification of the Primary Investigator\n- the title of the survey (including country, acronym and year of implementation)\n- the survey reference number\n- the source and date of download","conditions":"APHRC data access condition\n\nAll non-APHRC staff seeking to use data generated at the Center must obtain written approval to use the data from the Director of Research.\nThis form is developed to assess applications for data use and facilitate responsible sharing of data with external partners\/collaborators\/researchers. By entering into this agreement, the undersigned agrees to use these data only for the purpose for which they were obtained and to abide by the conditions outlined below:\n\n1.Data Ownership:\nThe data remain the property of APHRC; any unauthorized reproduction and sharing of the data is strictly prohibited. The user will, therefore, not release nor permit others to use or release the data to any other person without the written authorization from the Center.\n\n2.Purpose:\nThe provided data must be used for the purpose specified in the Data Request Form; any other use not specified in the form must receive additional or separate authorization.\n\n3.Respondent Identifiers:\nThe Center is committed to protecting the identity of the respondents who provide information in its research. All analytical data sets (both qualitative and quantitative) released by the Data Unit MUST are stripped of respondent identifiers to protect the identity of the respondents. By accepting to use APHRC data, the user is pledging that he\/she will not, under any circumstance, regenerate the identifiers or permit others to use the data to learn the identity of any individual, household or community included in any data set.\n\n4.Confidentiality pledge:\nThe user will not use nor permit others to use the data to report any information in the data sets that could identify, directly or by inference, individuals or households.\n\n5.Reporting of errors or inconsistencies:\nThe user will promptly notify the Head of the Statistics and Survey Unit any errors discovered in the data as soon as the errors are discovered.\n\n6.Publications resulting from APHRC data:\nThe Center requires external collaborators to work with APHRC staff on all publications resulting from its data. In order to facilitate this, lead authors should send a detailed concept note of the paper (including the background, rationale, data, analytical methods, and preliminary findings) to the Principle Investigator (or Theme Leader) for the project (with a copy to the Director of Research), who will circulate the abstract to concerned researchers for possible expression of interest in participating in the publication as co-authors. Any exception to the involvement of APHRC staff should be approved by the Director of Research, APHRC.\n\n7.Security:\nThe user will take responsibility for the security of the data by ensuring that the data are used and stored in a secure environment where access is password protected. This will ensure that non-authorized people should not have access to the data.\n\n8.Loss of privilege to use data:\nIn the event that APHRC determines that the data user is in violation of the conditions for using the data, or if the user wishes to cancel this agreement, the user will destroy the data files provided to him\/her. APHRC retains the right to revoke this agreement or informs publishers to withhold publication of any work based wholly or in part on its data if the conditions for using the data are violated.\n\n9.Acknowledgement:\nAny work\/reports from this data must acknowledge APHRC as the source of these data. For example, the suggested acknowledgement for NUHDSS data is:\n\"This research uses livelihoods data collected under the longitudinal Nairobi Urban Health and Demographic Surveillance System (NUHDSS) since 2006. The NUHDSS is carried out by the African Population and Health Research Center in two slums settlements (Korogocho and Viwandani) in Nairobi City.\"Additionally all funders, the study communities that provided the data, and staff who collected and analyzed or processed the data should be acknowledged.\n\n10.Deposit of Reports\/Papers:\nThe user should submit electronic and paper copies of all publications generated using APHRC data to the Policy Engagement and Communications Department, with copies to the Director of Research.\n\n11.Change of contact details:","disclaimer":"The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses."}}}}