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Nutrition and dietary intake and their association with mortality and hospitalisation in adults with chronic kidney disease treated with haemodialysis: protocol for DIET-HD, a prospective multinational cohort study.

Nutrition and dietary intake and their association with mortality and hospitalisation in adults with chronic kidney disease treated with haemodialysis: protocol for DIET-HD, a prospective multinational cohort study.

BMJ Open. 2015;5(3):e006897

Authors: Palmer SC, Ruospo M, Campbell KL, Garcia Larsen V, Saglimbene V, Natale P, Gargano L, Craig JC, Johnson DW, Tonelli M, Knight J, Bednarek-Skublewska A, Celia E, Del Castillo D, Dulawa J, Ecder T, Fabricius E, Frazão JM, Gelfman R, Hoischen SH, Schön S, Stroumza P, Timofte D, Török M, Hegbrant J, Wollheim C, Frantzen L, Strippoli GF, DIET-HD Study investigators

Abstract
INTRODUCTION: Adults with end-stage kidney disease (ESKD) treated with haemodialysis experience mortality of between 15% and 20% each year. Effective interventions that improve health outcomes for long-term dialysis patients remain unproven. Novel and testable determinants of health in dialysis are needed. Nutrition and dietary patterns are potential factors influencing health in other health settings that warrant exploration in multinational studies in men and women treated with dialysis. We report the protocol of the “DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study,” a multinational prospective cohort study. DIET-HD will describe associations of nutrition and dietary patterns with major health outcomes for adults treated with dialysis in several countries.
METHODS AND ANALYSIS: DIET-HD will recruit approximately 10?000 adults who have ESKD treated by clinics administered by a single dialysis provider in Argentina, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden and Turkey. Recruitment will take place between March 2014 and June 2015. The study has currently recruited 8000 participants who have completed baseline data. Nutritional intake and dietary patterns will be measured using the Global Allergy and Asthma European Network (GA(2)LEN) food frequency questionnaire. The primary dietary exposures will be n-3 and n-6 polyunsaturated fatty acid consumption. The primary outcome will be cardiovascular mortality and secondary outcomes will be all-cause mortality, infection-related mortality and hospitalisation.
ETHICS AND DISSEMINATION: The study is approved by the relevant Ethics Committees in participating countries. All participants will provide written informed consent and be free to withdraw their data at any time. The findings of the study will be disseminated through peer-reviewed journals, conference presentations and to participants via regular newsletters. We expect that the DIET-HD study will inform large pragmatic trials of nutrition or dietary interventions in the setting of advanced kidney disease.

PMID: 25795691 [PubMed – as supplied by publisher]

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Asthma Study for African American Women Announced

Call for Participation

Clinicaltrials.gov, a service of the U.S. National Institute of Health is announcing a study protocol for Women of Color and Asthma Control: A randomized controlled trial of an asthma-management intervention for African American women

Among adults in the United States, asthma prevalence is disproportionately high among African American women; this group also experiences the highest levels of asthma-linked mortality and asthma-related health care utilization. Factors linked to biological sex (e.g ., hormonal fluctuations), gender roles (e.g ., exposure to certain triggers) and race (e.g ., inadequate access to care) all contribute to the excess asthma burden in this group, and also shape the context within which African American women manage their condition.

No prior interventions for improving asthma self-management have specifically targeted this vulnerable group of asthma patients. The current study aims to evaluate the efficacy of a culturally- and gender-relevant asthma-management intervention among African American women.

Methods: A randomized controlled trial will be used to compare a five-session asthma-management intervention with usual care.

This intervention is delivered over the telephone by a trained health educator. Intervention content is informed by the principles of self-regulation for disease management, and all program activities and materials are designed to be responsive to the specific needs of African American women.

We will recruit 420 female participants who self-identify as African American, and who have seen a clinician for persistent asthma in the last year. Half of these will receive the intervention.

The primary outcomes, upon which the target sample size is based, are number of asthma-related emergency department visits and overnight hospitalizations in the last 12 months. We will also assess the effect of the intervention on asthma symptoms and asthma-related quality of life.

Data will be collected via telephone survey and medical record review at baseline, and 12 and 24 months from baseline. DiscussionWe seek to decrease asthma-related health care utilization and improve asthma-related quality of life in African American women with asthma, by offering them a culturally- and gender-relevant program to enhance asthma management. The results of this study will provide important information about the feasibility and value of this program in helping to address persistent racial and gender disparities in asthma outcomes.Trial Registration For additional information visit: Clinicaltrials.gov NCT01117805