Terminé

CHARTFormation et éducation améliorées pour réduire les hospitalisations chez les patients insuffisants cardiaques à faible revenu

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Ce qui est testé

Enhanced Training

+ Enhanced Education

Comportemental
Qui peut participer

Maladies Cardiovasculaires

+ Maladies Cardiaques

+ Insuffisance cardiaque

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude de prévention

Phase 3
Interventionnel
Date de début : mai 2011
Voir le détail du protocole

Résumé

Sponsor principalLynda Powell, PhD, MEd
Dernière mise à jour : 19 avril 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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.

Sponsor principalLynda Powell, PhD, MEd
Dernière mise à jour : 19 avril 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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.
Détails du design

320 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Prévention

Cette étude cherche à prévenir l'apparition d'une maladie ou d'un trouble chez des personnes qui ne l'ont pas encore développé. Elles concernent souvent des personnes à risque et testent des vaccins, des changements de mode de vie ou des traitements préventifs.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

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

Maladies CardiovasculairesMaladies CardiaquesInsuffisance cardiaque

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.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
The Enhanced Training intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. Randomization occurs at the PCP-level, that is, patients are assigned to the Enhanced Training group only if their PCP has been enrolled and randomized to this group. Descriptions of the intervention on the PCP-level and patient-level are provided in the intervention section.

Groupe II

Comparateur actif
The Enhanced Education intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention strategy revolves around providing nominal information through the mail. Randomization occurs at the PCP-level; that is, patients are assigned to the Enhanced Education group only if their PCP already has been enrolled and randomized to this group. Description of the intervention on the PCP-level and patient-level is provided in the intervention section.

Objectifs 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
Terminé1 Centres d'Étude