Dataset Information

Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial.

ABSTRACT:

Introduction

In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients' health behaviours and HBCPs' work satisfaction.

Methods and analysis

This is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs' programme; (2) HBCPs' programme + mobile?health application) and usual care (control). Currently, nine hospitals run the HBCPs' programme. Under each hospital, administrative areas implementing the HBCPs' programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs' programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.

Ethics and dissemination

Ethics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT03376607; Pre-results.

SUBMITTER: Lygidakis C

PROVIDER: S-EPMC6661689 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial.

Lygidakis Charilaos C Uwizihiwe Jean Paul JP Kallestrup Per P Bia Michela M Condo Jeanine J Vögele Claus C

BMJ open 20190724 7

<h4>Introduction</h4>In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the ...[more]

PMID: 31345971

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Project description:BackgroundCommunity health clubs are multi-session village-level gatherings led by trained facilitators and designed to promote healthy behaviours mainly related to water, sanitation, and hygiene. They have been implemented in several African and Asian countries but have never been evaluated rigorously. We aimed to evaluate the effect of two versions of the community health club model on child health and nutrition outcomes.MethodsWe did a cluster-randomised trial in Rusizi district, western Rwanda. We defined villages as clusters. We assessed villages for eligibility then randomly selected 150 for the study using a simple random sampling routine in Stata. We stratified villages by wealth index and by the proportion of children younger than 2 years with caregiver-reported diarrhoea within the past 7 days. We randomly allocated these villages to three study groups: no intervention (control; n=50), eight community health club sessions (Lite intervention; n=50), or 20 community health club sessions (Classic intervention; n=50). Households in these villages were enrolled in 2013 for a baseline survey, then re-enrolled in 2015 for an endline survey. The primary outcome was caregiver-reported diarrhoea within the previous 7 days in children younger than 5 years. Analysis was by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT01836731.FindingsAt the baseline survey undertaken between May, 2013, and August, 2013, 8734 households with children younger than 5 years of age were enrolled. At the endline survey undertaken between Sept 21, 2015, and Dec 22, 2015, 7934 (91%) of the households were re-enrolled. Among children younger than 5 years, the prevalence of caregiver-reported diarrhoea in the previous 7 days was 514 (14%) of 3616 assigned the control, 453 (14%) of 3196 allocated the Lite intervention (prevalence ratio compared with control 0·97, 95% CI 0·81-1·16; p=0·74), and 495 (14%) of 3464 assigned the Classic intervention (prevalence ratio compared with control 0·99, 0·85-1·15; p=0·87).InterpretationCommunity health clubs, in this setting in western Rwanda, had no effect on caregiver-reported diarrhoea among children younger than 5 years. Our results question the value of implementing this intervention at scale for the aim of achieving health gains.FundingBill & Melinda Gates Foundation.

Project description:BackgroundRoutine data are increasingly used in randomised controlled trials evaluating healthcare interventions. They can aid participant identification, outcome assessment, and intervention delivery. Randomised implementation trials evaluate the effect of implementation strategies on implementation outcomes. Implementation strategies, such as reminders, are used to increase the uptake of evidence-based interventions into practice, while implementation outcomes, such as adoption, are key measures of the implementation process. The use of routine data in effectiveness trials has been explored; however, there are no reviews on implementation trials. We therefore aimed to describe how routine data have been used in randomised implementation trials and the design characteristics of these trials.MethodsWe searched MEDLINE (Ovid) and Cochrane Central Register of Controlled Trials from Jan 2000 to Dec 2021 and manually searched protocols from trial registers. We included implementation trials and type II and type III hybrid effectiveness-implementation trials conducted using routine data. We extracted quantitative and qualitative data and narratively synthesised findings.ResultsFrom 4206 titles, we included 80 trials, of which 22.5% targeted implementation of evidence-based clinical guidelines. Multicomponent implementation strategies were more commonly evaluated (70.0%) than single strategies. Most trials assessed adoption as the primary outcome (65.0%). The majority of trials extracted data from electronic health records (EHRs) (62.5%), and 91.3% used routine data for outcome ascertainment. Reported reasons for using routine data were increasing efficiency, assessing outcomes, reducing research burden, improving quality of care, identifying study samples, confirming findings, and assessing representativeness. Data quality, the EHR system, research governance, and external factors such as government policy could act either as facilitators or barriers.ConclusionsAdherence to guidance on designing and reporting implementation studies, and specifically to harmonise the language used in describing implementation strategies and implementation outcomes, would aid identification of studies and data extraction. Routine healthcare data are widely used for participant identification, outcome assessment and intervention delivery. Researchers should familiarise themselves with the barriers and facilitators to using routine data, and efforts could be made to improve data quality to overcome some of the barriers.RegistrationPROSPERO CRD42022292321.

Project description:The inSCALE cluster randomised controlled trial in Uganda evaluated two interventions, mHealth and Village Health Clubs (VHCs) which aimed to improve Community Health Worker (CHW) treatment for malaria, diarrhoea, and pneumonia within the national Integrated Community Case Management (iCCM) programme. The interventions were compared with standard care in a control arm. In a cluster randomised trial, 39 sub-counties in Midwest Uganda, covering 3167 CHWs, were randomly allocated to mHealth; VHC or usual care (control) arms. Household surveys captured parent-reported child illness, care seeking and treatment practices. Intention-to-treat analysis estimated the proportion of appropriately treated children with malaria, diarrhoea, and pneumonia according to WHO informed national guidelines. The trial was registered at ClinicalTrials.gov (NCT01972321). Between April-June 2014, 7679 households were surveyed; 2806 children were found with malaria, diarrhoea, or pneumonia symptoms in the last one month. Appropriate treatment was 11% higher in the mHealth compared to the control arm (risk ratio [RR] 1.11, 95% CI 1.02, 1.21; p = 0.018). The largest effect was on appropriate treatment for diarrhoea (RR 1.39; 95% CI 0.90, 2.15; p = 0.134). The VHC intervention increased appropriate treatment by 9% (RR 1.09; 95% CI 1.01, 1.18; p = 0.059), again with largest effect on treatment of diarrhoea (RR 1.56, 95% CI 1.04, 2.34, p = 0.030). CHWs provided the highest levels of appropriate treatment compared to other providers. However, improvements in appropriate treatment were observed at health facilities and pharmacies, with CHW appropriate treatment the same across the arms. The rate of CHW attrition in both intervention arms was less than half that of the control arm; adjusted risk difference mHealth arm -4.42% (95% CI -8.54, -0.29, p = 0.037) and VHC arm -4.75% (95% CI -8.74, -0.76, p = 0.021). Appropriate treatment by CHWs was encouragingly high across arms. The inSCALE mHealth and VHC interventions have the potential to reduce CHW attrition and improve the care quality for sick children, but not through improved CHW management as we had hypothesised. Trial Registration:ClinicalTrials.gov (NCT01972321).

Project description:BackgroundThe rising prevalence of hearing loss is a global health concern. Professional hearing services are largely absent within low- and middle-income countries where appropriate skills are lacking. Task-shifting to community healthcare workers (CHWs) supported by mHealth technologies is an important strategy to address the problem.ObjectiveTo evaluate the feasibility of a community-based rehabilitation model providing hearing aids to adults in low-income communities using CHWs supported by mHealth technologies.MethodBetween September 2020 and October 2021, hearing aid assessments and fittings were implemented for adults aged 18 and above in two low-income communities in the Western Cape, South Africa, using trained CHWs. A quantitative approach with illustrative open-ended questions was utilised to measure and analyse hearing aid outcomes. Data were collected through initial face-to-face interviews, telephone interviews, and face-to-face visits post-fitting. Responses to open-ended questions were analysed using inductive thematic analysis. The International Outcome Inventory - Hearing Aids questionnaire determined standardised hearing aid outcomes.ResultsOf the 152 adults in the community who self-reported hearing difficulties, 148 were successfully tested by CHWs during home visits. Most had normal hearing (39.9%), 24.3% had bilateral sensorineural hearing loss, 20.9% had suspected conductive hearing loss, and 14.9% had unilateral hearing loss, of which 5.4% had suspected conductive loss. Forty adults met the inclusion criteria to be fitted with hearing aids. Nineteen of these were fitted bilaterally. Positive hearing aid outcomes and minimal device handling challenges were reported 45 days post-fitting and were maintained at six months. The majority (73.7%) of participants fitted were still making use of their hearing aids at the six-month follow-up.ConclusionsImplementing a hearing healthcare service-delivery model facilitated by CHWs in low-income communities is feasible. mHealth technologies used by CHWs can support scalable service-delivery models with the potential for improved access and affordability in low-income settings.

Project description:IntroductionRecognizing the burden experienced by caregivers of stroke survivors, an intervention using mobile health applications (mHealth apps) has been proposed to support and empower stroke caregivers. This study aimed to assess the acceptability and expectations of healthcare providers, who play a vital role as gatekeepers in the healthcare system, to ensure the effectiveness and sustainability of the intervention.MethodsThis was a concurrent mixed-method study design, with healthcare providers involved in stroke care management in the northeast regions of Malaysia as study participants. The qualitative component of the study was conducted using a phenomenological approach that involved in-depth interviews to explore the acceptability and expectations of healthcare providers regarding the adoption of mHealth apps in the context of stroke caregiving. The study was complemented by quantitative data collected through an online survey using an adjusted version of the technology acceptance model tool.ResultsIn total, 239 participants from diverse backgrounds and professions were enrolled in the study, with 12 in the qualitative component and 227 in the quantitative component. The findings from the quantitative survey showed that over 80% of the participants expressed their intention to use mHealth apps. The qualitative component generated two themes related to the acceptability and expectations of mHealth apps, which were integrated with the quantitative findings. Additionally, in-depth interviews revealed a new theme, namely the key features of mHealth, with three sub-themes: availability of services for caregivers, provision of knowledge skills, and supporting caregivers in managing stroke patients.ConclusionHealthcare providers demonstrated excellent acceptability of this mHealth intervention as part of caregiving assistance, particularly with the inclusion of essential key features. However, future investigations are necessary to establish the feasibility of integrating the mHealth app into the healthcare system and to ensure its long-term sustainability.

Project description:BackgroundSharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation versus no Email List Invitation to see which approach resulted in the highest patient satisfaction with how the results were communicated.Methods and findingsWe carried out a cluster randomised, 2 by 2 by 2 factorial, nonblinded study within a trial, with semistructured qualitative interviews with some patients (ISRCTN96189403). Each cluster was a UK hospital participating in the ICON8 ovarian cancer trial. Interventions were shared with 384 ICON8 participants who were alive and considered well enough to be contacted, at 43 hospitals. Hospitals were allocated to share results with participants through one of the 8 intervention combinations based on random permutation within blocks of 8, stratified by number of participants. All interventions contained a written plain English summary of the results. The Enhanced Webpage also contained a short video. Both the Enhanced Webpage and Email contained links to further information and support. The Mailed Printed Summary was opt-out. Follow-up questionnaires were sent 1 month after patients had been offered the interventions. Patients' reported satisfaction was measured using a 5-point scale, analysed by ordinal logistic regression estimating main effects for all 3 interventions, with random effects for site, restricted to those who reported receiving the results and assuming no interaction. Data collection took place in 2018 to 2019. Questionnaires were sent to 275/384 randomly selected participants and returned by 180: 90/142 allocated Basic Webpage, 90/133 Enhanced Webpage; 91/141 no Mailed Printed Summary, 89/134 Mailed Printed Summary; 82/129 no Email List Invitation, 98/146 Email List Invitation. Only 3 patients opted out of receiving the Mailed Printed Summary; no patients signed up to the email list. Patients' satisfaction was greater at sites allocated the Mailed Printed Summary, where 65/81 (80%) were quite or very satisfied compared to sites with no Mailed Printed Summary 39/64 (61%), ordinal odds ratio (OR) = 3.15 (1.66 to 5.98, p < 0.001). We found no effect on patient satisfaction from the Enhanced Webpage, OR = 1.47 (0.78 to 2.76, p = 0.235) or Email List Invitation, OR = 1.38 (0.72 to 2.63, p = 0.327). Interviewees described the results as interesting, important, and disappointing (the ICON8 trial found no benefit). Finding out the results made some feel their trial participation had been more worthwhile. Regardless of allocated group, patients who received results generally reported that the information was easy to understand and find, were glad and did not regret finding out the results. The main limitation of our study is the 65% response rate.ConclusionsNearly all respondents wanted to know the results and were glad to receive them. Adding an opt-out Mailed Printed Summary alongside a webpage yielded the highest reported satisfaction. This study provides evidence on how to share results with other similar trial populations. Further research is needed to look at different results scenarios and patient populations.Trial registrationISRCTN: ISRCTN96189403.

Project description:BackgroundBronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users' perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data.MethodsA pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis.ResultsThe cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being the greatest barrier to their use.ConclusionOur targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .

Project description:INTRODUCTION:Cultivating child health and development creates long-term impact on the well-being of the individual and society. The Amazon of Peru has high levels of many risk factors that are associated with poor child development. The use of 'community health agents' (CHAs) has been shown to be a potential solution to improve child development outcomes. Additionally, mobile information and communication technology (ICT) can potentially increase the performance and impact of CHAs. However, there is a knowledge gap in how mobile ICT can be deployed to improve child development in low resource settings. METHODS AND ANALYSIS:The current study will evaluate the implementation and impact of a tablet-based application that intends to improve the performance of CHAs, thus improving the child-rearing practices of caregivers and ultimately child health and development indicators. The CHAs will use the app during their home visits to record child health indicators and present information, images and videos to teach key health messages. The impact will be evaluated through an experimental cluster randomised controlled trial. The clusters will be assigned to the intervention or control group based on a covariate-constrained randomisation method. The impact on child development scores, anaemia and chronic malnutrition will be assessed with an analysis of covariance. The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services. The process evaluation will report on implementation outcomes. The study will be implemented in the Amazon region of Peru with children under 4. The results of the study will provide evidence on the potential of a mHealth tool to improve child health and development indicators in the region. ETHICS AND DISSEMINATION:The study received approval from National Hospital 'San Bartolome' Institutional Ethics Committee on 8 November 2018 (IRB Approval #15463-18) and will be disseminated via peer-reviewed publications. TRIAL REGISTRATION NUMBER:ISRCTN43591826.

Project description:Limited communication and care coordination following discharge from hospitals may contribute to surgical complications. Smartphone apps offer a novel mechanism for communication and care coordination. However, factors which may affect patient app use in a postoperative, at-home setting are poorly understood.The objectives of this study were to (1) gauge interest in smartphone app use among patients after colorectal surgery and (2) better understand factors affecting patient app use in a postoperative, at-home setting.A prospective feasibility study was performed at a hospital that principally serves low socioeconomic status patients. After colorectal surgery, patients were enrolled and given a smartphone app, which uses previously validated content to provide symptom-based recommendations. Patients were instructed to use the app daily for 14 days after discharge. Demographics and usability data were collected at enrollment. Usability was measured with the System Usability Scale (SUS). At follow-up, the SUS was repeated and patients underwent a structured interview covering ease of use, willingness to use, and utility of use. Two members of the research team independently reviewed the field notes from follow-up interviews and extracted the most consistent themes. Chart and app log reviews identified clinical endpoints.We screened 115 patients, enrolled 20 patients (17.4%), and completed follow-up interviews with 17 patients (85%). Reasons for nonenrollment included: failure to meet inclusion criteria (47/115, 40.9%), declined to participate (26/115, 22.6%), and other reasons (22/115, 19.1%). There was no difference in patient ratings between usability at first-use and after extended use, with SUS scores greater than the 95th percentile at both time points. Despite high usability ratings, 6/20 (30%) of patients never used the app at home after hospital discharge and 2/20 (10%) only used the app once. Interviews revealed three themes related to app use: (1) patient-related barriers could prevent use even though the app had high usability scores; (2) patients viewed the app as a second opinion, rather than a primary source of information; and (3) many patients viewed the app as an external burden.Use patterns in this study, and response rates after prompts to contact the operative team, suggest that apps need to be highly engaging to be adopted by patients. The growing penetration of smartphones and the proliferation of app-based interventions are unlikely to improve care coordination and communication, unless apps address the barriers and patient perceptions identified in this study. This study shows that high usability alone is not sufficient to motivate patients to use smartphone apps in the postoperative period.

Dataset Information

Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial.

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