Design and Region-Specific Adaptation of the Dietary Intervention Used in the SODIUM-HF Trial: A Multicentre Study.

BACKGROUND: Restricting dietary sodium consumption has been considered a major component of self-care management in heart failure (HF); however, the evidence supporting this recommendation has not been conclusive. The Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF) trial aims to assess the effects of dietary sodium reduction on clinical outcomes in a HF population using a pragmatic design to provide empirical evidence to guide dietary sodium intake recommendations in patients with chronic HF. METHODS: SODIUM-HF is a multicentre, open-label, blinded adjudicated endpoint, randomized controlled trial in ambulatory patients with chronic HF. This trial involves participants recruited from sites in Canada, Australia, New Zealand, Mexico, Colombia, and Chile, who are followed up to 24 months. Rationale and methods of the SODIUM-HF trial were published elsewhere. As an international pragmatic dietary trial, SODIUM-HF was designed to address several challenges, such as defining the most suitable intervention to account for country-specific variations in food intake and availability. In SODIUM-HF, we implemented the Nutrition-Care Model to provide a comprehensive intervention delivered directly to patients, focusing on modifying the nutrient composition of the diet (sodium restriction), using a personalized counselling and close follow-up. RESULTS: Available upon completion of the trial. CONCLUSIONS: This long-term dietary trial is one of the first in its type in the HF field. This article describes in detail the rationale and methods for the dietary intervention employed and the region-specific adaptation of the SODIUM-HF intervention, so that the learning and processes taken in this trial can be applied to future multicountry dietary clinical trials.

CONTEXTE: La restriction de l'apport en sodium alimentaire est considérée comme étant un élément important de l'auto-prise en charge de l'insuffisance cardiaque (IC); or, les données à l'appui de cette recommandation ne sont pas concluantes. L'étude SODIUM-HF ( S tudy o f D ietary I ntervention U nder 100 M MOL in H eart F ailure) vise à évaluer en contexte réel les effets de la réduction de l'apport en sodium alimentaire sur les résultats cliniques au sein d'une population de patients atteints d'IC, afin d'obtenir des données empiriques qui serviront à orienter les recommandations en matière d'apport en sodium alimentaire chez les patients atteints d'IC chronique. MÉTHODOLOGIE: L'étude SODIUM-HF est un essai multicentrique contrôlé avec répartition aléatoire et mené en mode ouvert auprès de patients ambulatoires atteints d'IC chronique, dont les paramètres sont évalués à l'insu. Les participants sont recrutés dans des centres situés au Canada, en Australie, en Nouvelle-Zélande, au Mexique, en Colombie et au Chili, et font l'objet d'un suivi pendant 24 mois. La raison d'être et la méthodologie de l'étude SODIUM-HF sont présentées ailleurs. Comme il s'agit d'une étude internationale sur l'alimentation menée en contexte réel, l'étude SODIUM-HF a été conçue de manière à résoudre plusieurs difficultés, dont la façon la plus appropriée de tenir compte des variations entre pays en matière d'apport alimentaire et de disponibilité des aliments. L'étude met en œuvre le processus de soins en nutrition, afin d'assurer directement auprès des patients une intervention exhaustive axée sur la modification de la composition en nutriments de l'alimentation (restriction de l'apport en sodium) et faisant appel à des conseils personnalisés et à un suivi étroit. RÉSULTATS: Les résultats seront publiés à la fin de l'étude. CONCLUSIONS: Cette étude de longue durée sur l'alimentation est l'une des premières en son genre dans le domaine de l'IC. Les auteurs décrivent en détail la raison d'être et la méthodologie des mesures d'intervention alimentaire employées ainsi que les adaptations propres à chaque région mises en œuvre dans le cadre de l'étude SODIUM-HF, afin que les apprentissages et les processus issus de l'étude puissent être utilisés dans d'autres études cliniques multinationales sur l'alimentation.

Validation of a self-administered version of the Mediterranean diet scale (MDS) for cardiac rehabilitation patients in Canada.

The Mediterranean dietary pattern has been linked with lower incidence of cardiovascular disease and the Mediterranean diet scale (MDS) has been created to incorporate and test the inherent characteristics of this dietary pattern. This study aimed to psychometrically validate a self-administered version of the MDS in cardiac rehabilitation (CR) patients in Canada. To establish content validity, the scale was reviewed by an expert interdisciplinary panel. A final version of the tool was tested in 150 CR patients. Cronbach's alpha was 0.69. All ICC coefficients met the minimum recommended standard. Factor analysis revealed four factors, all internally consistent. Criterion validity was supported by significant differences in total scores by duration in CR. Construct validity was supported by agreements between the self-administered MDS and original MDS in all items and with the 3-day food record in 8 of 13 items. In conclusion, the self-administered version of the MDS demonstrated good reliability and validity.

Cardiac rehabilitation wait times: effect on enrollment.

PURPOSE: Cardiac rehabilitation (CR) is a proven effective means for secondary prevention of coronary heart disease. Timely access to CR services is key to promoting patient participation and ensuring optimal patient outcomes. Despite wait time benchmarks having been established, research regarding how long patients wait to enter CR following referral receipt is limited. The aim of this study was to (a) describe wait times from CR referral to intake assessment and (b) examine the association of wait time to CR enrollment rates. METHODS: Wait time from date of CR referral to date of intake assessment was calculated in days for 599 participants referred to CR from 2006 to 2009 inclusive. A descriptive examination of sociodemographic and clinical characteristics was performed, followed by logistic regression analysis to assess the wait time by enrollment relationship. RESULTS: Median wait time from referral receipt to CR intake was 42.0 days. Wait time had a negative effect on CR enrollment, such that for every 1-day increment in wait time, patients were 1% less likely to enroll. CONCLUSIONS: The time that patients wait to enroll in CR may affect the number of patients who choose to attend, and longer wait times may mean fewer patients will benefit from CR participation. Programs should be encouraged to undertake quality improvement initiatives to ensure wait times are not negatively impacting patient enrollment and ultimately preventing patients from benefiting from CR participation. Further research is needed to establish evidence-based wait time benchmarks and interventions to promote timely access to CR services.