Feasibility and effectiveness of self-monitoring of blood glucose among insulin-dependent patients with type 2 diabetes: open randomized control trial in three rural districts in Rwanda.

BACKGROUND: The prevalence of type 2 diabetes in sub Saharan Africa (SSA) has been on the rise. Effective control of blood glucose is key towards reducing the risk of diabetes complications. Findings mainly from high-income countries have demonstrated the effectiveness of self-monitoring of blood-glucose (SMBG) in controlling blood glucose levels. However, there are limited studies describing the implementation of SMBG in rural SSA. This study explores the feasibility and effectiveness of implementing SMBG among patients diagnosed with insulin-dependent type 2 diabetes in rural Rwanda. METHODS: Participants were randomized into intervention (n = 42) and control (n = 38) groups. The intervention group received a glucose-meter, blood test-strips, log-book, waste management box and training on SMBG in addition to usual care. The control group continued with their usual care consisting of, routine monthly medical consultation and health education. The primary outcomes were adherence to the implementation of SMBG (testing schedule and recording data in the log-book) and change in hemoglobin A1c. Descriptive statistics and a paired t-test were used to analyze the primary outcomes. RESULTS: In both the intervention and control arms, majority of the participants were female (59.5% vs 52.6%) and married (71.4% vs 73.7%). Most had at most a primary level education (83.3% vs. 89.4%) and were farmers (54.8% vs. 50.0%). Among those in the intervention group, 63.4% showed good adherence to implementing SMBG based on the number of tests recorded in the glucose meter. Only 20.3% demonstrated accurate recording of the glucose level tests in log-books. The mean difference of the HbA1C from baseline to six months post-intervention was significantly better among the intervention group -0.94% (95% CI -1.46, -0.41) compared to the control group 0.73% (95% CI -0.09, 1.54) p < 0.001. CONCLUSION: Our study showed that among patients with insulin-dependent type 2 diabetes residing in rural Rwanda, SMBG was feasible and demonstrated positive outcomes in improving blood glucose control. However, there is need for strategies to enhance accuracy in recording blood glucose test results in the log-book. TRIAL REGISTRATION: The trial was registered retrospectively on the Pan African Clinical Trial Registry, on 17th May 2019. The registration number is PACTR201905538846394.

Implementation outcomes of national decentralization of integrated outpatient services for severe non-communicable diseases to district hospitals in Rwanda.

OBJECTIVES: Effective coverage of non-communicable disease (NCD) care in sub-Saharan Africa remains low, with the majority of services still largely restricted to central referral centres. Between 2015 and 2017, the Rwandan Ministry of Health implemented a strategy to decentralise outpatient care for severe chronic NCDs, including type 1 diabetes, heart failure and severe hypertension, to rural first-level hospitals. This study describes the facility-level implementation outcomes of this strategy. METHODS: In 2014, the Ministry of Health trained two nurses in each of the country's 42 first-level hospitals to implement and deliver nurse-led, integrated, outpatient NCD clinics, which focused on severe NCDs. Post-intervention evaluation occurred via repeated cross-sectional surveys, informal interviews and routinely collected clinical data over two rounds of visits in 2015 and 2017. Implementation outcomes included fidelity, feasibility and penetration. RESULTS: By 2017, all NCD clinics were staffed by at least one NCD-trained nurse. Among the approximately 27 000 nationally enrolled patients, hypertension was the most common diagnosis (70%), followed by type 2 diabetes (19%), chronic respiratory disease (5%), type 1 diabetes (4%) and heart failure (2%). With the exception of warfarin and beta-blockers, national essential medicines were available at more than 70% of facilities. Clinicians adhered to clinical protocols at approximately 70% agreement with evaluators. CONCLUSION: The government of Rwanda was able to scale a nurse-led outpatient NCD programme to all first-level hospitals with good fidelity, feasibility and penetration as to expand access to care for severe NCDs.

Cultural adaptation and psychometric evaluation of the Kinyarwanda version of the problem areas in diabetes (PAID) questionnaire.

BACKGROUND: High prevalence rates in diabetes-related distress have been observed in several studies; however, in the region of Sub-Saharan Africa evidence is lacking as is, for example, the case for Rwanda, where diabetes prevalence is expected to increase over the next decade. The aim of this study is to report on the translation and cultural adaption of the problem areas in diabetes (PAID) questionnaire into Kinyarwanda and its psychometric properties. METHODS: The questionnaire was translated following a standard procedure. Interviews were conducted with 29 participants before producing a final version. For the psychometric evaluation, a sample of 266 patients with diabetes mellitus, aged 21-64 years old were examined. Participants either came from a separate cluster-randomised controlled trial or were recruited ad-hoc for this study. The evaluation included testing internal consistency, known groups validity, and construct validity. A series of confirmatory factor analysis were conducted investigating seven previously established factorial structures. An exploratory factor analysis (EFA) was also carried out to examine the structure further. RESULTS: The full scale showed good internal reliability (Cronbach's α = 0.88). A four-factor solution previously tested in Spain with subdimensions of emotional, treatment, food-related and social-support problems demonstrated adequate approximate fit (RMSEA = 0.056; CFI = 0.951; TLI = 0.943). The EFA revealed a four-factor structure; however, two of these factors were not as homogeneous and easily interpretable as those of the Spanish model. CONCLUSIONS: The psychometric properties of the Kinyarwanda version of PAID are acceptable. The questionnaire can be helpful in research and clinical practice in Rwanda, however certain cross-cultural differences should be taken into account.

Road map for leadership and management in public health: a case study on noncommunicable diseases program managers' training in Rwanda.

Ministries of Health (MoHs) and health organizations are compelled to work across sectors and build coalitions, strengthening health systems to abate the rise of noncommunicable diseases (NCDs). A critical element of NCD prevention and control involves significant and difficult changes in attitudes, policies and protective behavior at the population level. The population-level impact of NCD interventions depends on the strength of the health system that delivers them. In particular, low-resource settings are exploring efficiencies and linkages to existing systems or partnerships in ways that may alleviate redundancies and high delivery costs. These entail complex operational challenges, and can only be spearheaded by a competent and passionate workforce. There is a critical need to develop and strengthen the management and leadership skills of public health professionals so that they can take on the unique challenges of NCD prevention and control. An added component must include a shift from the traditional clinical approach to a community-based effort, focusing heavily on health education and community norm change. Strengthening the work-force capacity of program managers at MoHs and other implementing institutions is key to capturing, analyzing, advocating and communicating information and will, in turn, reinforce the scale-up of interventions fostering a robust health system. This paper summarizes the best practices and lessons learned from the NCD Program Managers short course conducted by the US Centers for Disease Control and Prevention (CDC) in December, 2016 in Rwanda.

Using e-modules for acquisition of complex diabetes skills in diabetes care providers in Rwanda.

Type 1 Diabetes (T1D) is life-threatening without appropriate treatment. Though pediatric endocrinology care is limited in Rwanda, a decentralized health system allows access to local non-communicable disease (NCD) nurses through a network of 42 district hospitals. Recent rapid expansion of internet access in the country makes virtual diabetes education initiatives possible. We investigated whether Rwandan NCD nurses receiving diabetes education via online e-modules could make similar educational gains in insulin adjustment skills (IAS) compared to NCD nurses educated in a conference-style setting, and whether they would maintain equivalent competency at 1 year after education. We randomized 21 district hospitals and their NCD nurses to participate in a 1.5-day educational conference centered around care of type 1 diabetes (Group 1), while nurses from the remaining 21 hospitals (Group 2) received accommodation and access to equivalent educational materials in e-module form. Both groups were requested to review initial course materials at 4, 8, and 12 months. Ten-point IAS assessments were administered before and after education or review at each time point. Groups 1 and 2 had equal improvement after education (+2.0 vs. +2.0, p = 0.47) and equal final score at baseline (6.0 vs. 6.0, p = 0.74). However, both groups showed a diminishing improvement over time, so that any gains were lost by 4 months in Group 1 and 8 months in Group 2. Group 1 showed greater attrition in participation over time (19% vs 58% continued participation at one year, p = 0.002). Groups did not differ in subjective confidence in IAS after education. Both groups identified existing or potential access barriers to their respective educational method. While further modifications should be trialed to ensure equitable access and to maintain long-term engagement, online education is a feasible method to teach complex subspecialty skills to providers working in low-resource settings.

Identifying the necessary capacities for the adaptation of a diabetes phenotyping algorithm in countries of differing economic development status.

BACKGROUND: In 2019, the World Health Organization recognised diabetes as a clinically and pathophysiologically heterogeneous set of related diseases. Little is currently known about the diabetes phenotypes in the population of low- and middle-income countries (LMICs), yet identifying their different risks and aetiology has great potential to guide the development of more effective, tailored prevention and treatment. OBJECTIVES: This study reviewed the scope of diabetes datasets, health information ecosystems, and human resource capacity in four countries to assess whether a diabetes phenotyping algorithm (developed under a companion study) could be successfully applied. METHODS: The capacity assessment was undertaken with four countries: Trinidad, Malaysia, Kenya, and Rwanda. Diabetes programme staff completed a checklist of available diabetes data variables and then participated in semi-structured interviews about Health Information System (HIS) ecosystem conditions, diabetes programme context, and human resource needs. Descriptive analysis was undertaken. RESULTS: Only Malaysia collected the full set of the required diabetes data for the diabetes algorithm, although all countries did collect the required diabetes complication data. An HIS ecosystem existed in all settings, with variations in data hosting and sharing. All countries had access to HIS or ICT support, and epidemiologists or biostatisticians to support dataset preparation and algorithm application. CONCLUSIONS: Malaysia was found to be most ready to apply the phenotyping algorithm. A fundamental impediment in the other settings was the absence of several core diabetes data variables. Additionally, if countries digitise diabetes data collection and centralise diabetes data hosting, this will simplify dataset preparation for algorithm application. These issues reflect common LMIC health systems' weaknesses in relation to diabetes care, and specifically highlight the importance of investment in improving diabetes data, which can guide population-tailored prevention and management approaches.

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.

INTRODUCTION: Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement. METHODS AND ANALYSIS: This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants. ETHICS AND DISSEMINATION: This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: PACTR201905538846394; pre-results.

A Clinical Mentorship and Quality Improvement Program to Support Health Center Nurses Manage Type 2 Diabetes in Rural Rwanda.

INTRODUCTION: The prevalence of diabetes mellitus is rapidly rising in SSA. Interventions are needed to support the decentralization of services to improve and expand access to care. We describe a clinical mentorship and quality improvement program that connected nurse mentors with nurse mentees to support the decentralization of type 2 diabetes care in rural Rwanda. METHODS: This is a descriptive study. Routinely collected data from patients with type 2 diabetes cared for at rural health center NCD clinics between January 1, 2013 and December 31, 2015, were extracted from EMR system. Data collected as part of the clinical mentorship program were extracted from an electronic database. Summary statistics are reported. RESULTS: The patient population reflects the rural settings, with low rates of traditional NCD risk factors: 5.6% of patients were current smokers, 11.0% were current consumers of alcohol, and 11.9% were obese. Of 263 observed nurse mentee-patient encounters, mentor and mentee agreed on diagnosis 94.4% of the time. Similarly, agreement levels were high for medication, laboratory exam, and follow-up plans, at 86.3%, 87.1%, and 92.4%, respectively. CONCLUSION: Nurses that receive mentorship can adhere to a type 2 diabetes treatment protocol in rural Rwanda primary health care settings.

A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans.

Background. Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods. We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors. One hundred fifty participants were randomized 2:1 to switch to coformulated rilpivirine-emtricitabine-tenofovir disoproxil fumarate (referenced as the Switch Arm) or continue current therapy. The primary efficacy endpoint was HIV-1 RNA < 200 copies/mL at week 24 assessed by the US Food and Drug Administration Snapshot algorithm with a noninferiority margin of 12%. Results. Between April and September 2014, 184 patients were screened, and 150 patients were enrolled; 99 patients switched to rilpivirine-emtricitabine-tenofovir, and 51 patients continued their nevirapine-based ART. The mean age was 42 years and 43% of participants were women. At week 24, virologic suppression (HIV-1 RNA level <200 copies/mL) was maintained in 93% and 92% in the Switch Arm versus the continuation arm, respectively. The Switch Arm was noninferior to continued nevirapine-based ART (efficacy difference 0.8%; 95% confidence interval, -7.5% to +12.0%). Both regimens were generally safe and well tolerated, although 2 deaths, neither attributed to study medications, occurred in participants in the Switch Arm. Conclusions. A switch from nevirapine-based ART to rilpivirine-emtricitabine-tenofovir disoproxil fumarate had similar virologic efficacy to continued nevirapine-based ART after 24 weeks with few adverse events.