CHARTFormation et éducation améliorées pour réduire les hospitalisations chez les patients insuffisants cardiaques à faible revenu
Enhanced Training
+ Enhanced Education
Maladies Cardiovasculaires
+ Maladies Cardiaques
+ Insuffisance cardiaque
Étude de prévention
Résumé
Date de début de l'étude : 1 mai 2011
Date à laquelle le premier participant a commencé l'étude.The purpose of the CHART research study is to assess the value of a novel multi-level intervention for low-income patients recently hospitalized with heart failure relative to providing education alone (both strategies are described in detail in the Intervention section below). The investigators refer to their novel intervention strategy as 'Enhanced Training' and their education-only strategy the investigators refer to as 'Enhanced Education'. These two strategies of participant follow-up will be assessed and compared by analyzing patient's all-cause hospital days over a 2.5-year follow-up period (the investigators note that, for patients with heart failure, the average number of such all-cause hospital days over a 2.5-year period has tripled over the past 25 years). The Enhanced Training strategy aims to improve patient receipt of evidence-based therapy by: 1) activating patients using a culturally sensitive approach that might better resonate with the investigators predominantly urban, African-American and Hispanic, target population; 2) providing timely and useful information to the primary care provider; and 3) promoting effective communication between patients and their primary care provider. The Enhanced Education strategy is less intrusive and aims to provide patients and primary care providers with appropriate educational materials via mail. The primary aims of this research study are to determine if Enhanced Training and/or Enhanced Education will improve: patient adherence to drug therapy and salt restriction, health care provider adherence to evidence-based guidelines, and patient functional capacity and quality of life. Secondary aims will include assessing impact of the interventions on CRP and BNP, which are two key biomarkers of heart failure progression.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.320 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Inclusion Criteria (PCP) 1. Provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s). Inclusion Criteria (Patients) Participant has been diagnosed with Heart Failure (HF), Self reported family income is less than $30,000/year, Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon: Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers. Has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year. Age ≥ 18 years Currently resides in Cook County, Illinois. Speaks English or Spanish. The primary care provider (PCP) has consented and has no more than 12 patients enrolled. Completed the informed consent process. Successfully completed the 30-day run-in period and study baseline visit Exclusion Criteria: Exclusion Criteria (PCP) Health providers will be excluded from enrollment if they are: Still in their residency or training period, A member of the CHART research staff. Exclusion Criteria (Patients) Patients will be excluded from enrollment if they have: 1. An uncertain 12-month prognosis. Listed for imminent cardiac transplant. Has an advanced directive of "Do not resuscitate". Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Rush University Medical Center
Chicago, United StatesOuvrir Rush University Medical Center dans Google Maps