The impact of community-based non-pharmacological interventions on cardiovascular and kidney disease outcomes in remote dwelling Indigenous communities: A scoping review protocol.

INTRODUCTION: Indigenous people represent approximately 5% of the world's population. However, they often have a disproportionately higher burden of cardiovascular disease (CVD) risk and chronic kidney disease (CKD) than their equivalent general population. Several non-pharmacological interventions (e.g., educational) have been used to reduce CVD and kidney disease risk factors in Indigenous groups. The aim of this paper is to describe the protocol for a scoping review that will assess the impact of non-pharmacological interventions carried out in Indigenous and remote dwelling populations to reduce CVD risk factors and CKD. MATERIALS AND METHODS: This scoping review will be guided by the methodological framework for conducting scoping studies developed by Arksey and O'Malley. Both empirical (Medline, Embase, Cochrane Library, CINAHL, ISI Web of Science and PsycINFO) and grey literature references will be assessed if they focused on interventions targeted at reducing CVD or CKD among Indigenous groups. Two reviewers will independently screen references in consecutive stages of title/abstract screening and then full-text screening. Impact of interventions used will be assessed using the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework. A descriptive overview, tabular summaries, and content analysis will be carried out on the extracted data. ETHICS AND DISSEMINATION: This review will collect and analyse evidence on the impact of interventions of research carried out to reduce CVD and CKD among Indigenous populations. Such evidence will be disseminated using traditional approaches that includes open-access peer-reviewed publication, scientific presentations, and a report. Also, we will disseminate our findings to the government and Indigenous leaders. Ethical approval will not be required for this scoping review as the data used will be extracted from already published studies with publicly accessible data.

Telemonitoring and Case Management for Hypertensive and Remote-Dwelling Patients With Chronic Kidney Disease-The Telemonitoring for Improved Kidney Outcomes Study (TIKO): A Clinical Research Protocol.

BACKGROUND: Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control. OBJECTIVE: The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed. DESIGN: This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care. SETTING: Peace River region in Northern Alberta Region, Canada. PATIENTS: Primary care patients with CKD and hypertension. MEASUREMENTS: Eligible patients will be randomized 1:1 to HBPT + BP case management versus HBPT + usual care. In the intervention arm, BP will be measured 4 times daily for 1 week, with medications titrated up or down by the study case manager until guideline targets (systolic BP [SBP]: <130 mmHg) are achieved. Once BP is controlled, (ie, to guideline-concordant targets), this 1-week protocol will be repeated every 3 months for 1 year. Patients in the control arm will also follow the same BP measurement protocol; however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits. LIMITATIONS: Potential limitations of this study include the relatively short duration of follow-up, possible technological pitfalls, and need for patients to own a smartphone and have access to the internet to participate. CONCLUSIONS: As this study will focus on a high-risk population that has been characterized by a large care gap, it will generate important evidence that would allow targeted and effective population-level strategies to be implemented to improve health outcomes for high-risk hypertensive CKD patients in Canada's remote communities. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT number: NCT04098354).

CONTEXTE: L'hypertension et la pression artérielle (PA) mal contrôlée sont des facteurs de risque reconnus pour la néphropathie et la progression vers l'insuffisance rénale, en plus de poser un risque accru de morbidité et de mortalité cardiovasculaires. Plusieurs études chez des patients sans néphropathie ont démontré l'efficacité de la télésurveillance de la PA à domicile (TSPA) pour le contrôle de la PA. OBJECTIFS: Le principal objectif est d'évaluer la différence moyenne de pression artérielle systolique (PAS) après 12 mois par rapport à sa valeur initiale chez des patients atteints d'hypertension et d'insuffisance rénale chronique (IRC) habitant les communautés éloignées du nord de l'Alberta (Canada). Cet objectif sera atteint en comparant la TSPA + soins habituels à la TSPA + gestionnaire de cas. D'autres objectifs secondaires, notamment le rapport coût/efficacité de la TSPA, son acceptation et la survenue d'événements indésirables seront également évalués. TYPE D'ÉTUDE: Cette étude est conçue comme un essai randomisé contrôlé (ERC) pragmatique comparant la TSPA + prise en charge clinique des cas à la TSPA + soins habituels. CADRE: Région de Peace River dans le nord de l'Alberta (Canada). SUJETS: Patients atteints d'IRC et d'hypertension recevant des soins de santé primaires. MESURES: Les patients admissibles seront répartis 1:1 dans le groupe TSPA + prise en charge du cas d'hypertension ou dans le groupe témoin (TSPA + soins habituels). Dans le groupe d'intervention, la PA sera mesurée quatre fois par jour pendant une semaine, avec augmentation ou réduction de la médication par le gestionnaire de cas de l'étude jusqu'à ce que la cible de référence (PAS : <130 mmHg) soit atteinte. Une fois la PA contrôlée (c.-à-d. conforme aux cibles recommandées), ce protocole sur une semaine sera répété tous les trois mois pendant un an. Les patients du groupe témoin suivront le même protocole de mesure de la PA, mais sans interactions avec le gestionnaire de cas, ils transmettront plutôt leurs mesures de PA à leur médecin de soins primaires ou aux infirmières praticiennes lors de visites prévues. LIMITES: Cette étude est notamment limitée par la durée relativement courte du suivi, de possibles difficultés technologiques et la nécessité pour les participants de posséder un téléphone intelligent et d'avoir accès à l'Internet. CONCLUSION: Puisque cette étude se penchera sur une population à risque élevé et marquée par d'importantes lacunes en matière de soins, elle générera des données importantes qui aideront à mettre en œuvre des stratégies ciblées et efficaces au niveau de la population afin d'améliorer les évènements cliniques des patients hypertendus et atteints d'IRC à haut risque habitant les communautés éloignées au Canada.