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Cardiovascular Disease Education and Problem-Solving Training in People With Type 2 Diabetes (DECIDE)

11 mai 2015 mis à jour par: Felicia Hill-Briggs, Johns Hopkins University

Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics

The purpose of this study is to determine if patient education and problem-solving training, delivered in self-study, group, and individual intervention modalities, will produce substantial improvements in CVD risk profile via improved self management in urban African Americans with type 2 diabetes and a high CVD risk profile.

Aperçu de l'étude

Description détaillée

African Americans with type 2 diabetes suffer excess disease burden, but cardiovascular disease (CVD) risk factors such as hyperglycemia, hypertension, and dyslipidemia are modifiable with medical management and lifestyle modification. Patient diabetes education and counseling for behavior change are recommended standards of practice to facilitate effective self-management of these risk factors. However, for patients with low literacy or health literacy, accessibility and impact of educational and behavioral interventions are limited. Pilot research suggests that: a) literacy demand and behavioral activation characteristics of patient education modules can be adapted to facilitate learning in urban patients with low literacy, and b) combining literacy-adapted education with problem-solving training facilitates understanding and use of health information for performing self-management in the context of daily life (functional health literacy). Optimal modalities for delivery of a combined patient diabetes education and problem-solving training, and cost-effectiveness of this intervention model, however, are not known. The proposed study will address these needs by testing effectiveness and cost-effectiveness of literacy-adapted diabetes and CVD education and problem-solving training interventions in urban African Americans with type 2 diabetes and high CVD risk profile (suboptimal blood sugar, blood pressure, and/or lipids). The specific aims of the study are: a) to complete development of a package of literacy-adapted diabetes and CVD patient education materials by developing two video/DVDs addressing self-management recommendations appropriate to the needs, resources, and environment of the population; b) to randomize urban African-American adults with type 2 diabetes and a high CVD risk profile into one of four study arms: Usual Care (Arm 1), Literacy-Adapted Education and Problem-Solving Training Self-Study (Arm 2), Literacy-Adapted Education and Group Problem-Solving Training (Arm 3), and Literacy-Adapted Education and Individual Problem-Solving Training (Arm 4); c) to conduct baseline, 3-month post-intervention, and 6-month post-intervention assessment visits to analyze and compare effectiveness of the literacy-adapted education and problem-solving interventions, as compared to Usual Care, in improving the skills of knowledge, problem-solving and health literacy, behaviors of patient activation and diabetes self-management, and clinical outcomes of A1C, blood pressure and lipids; and d) to perform a cost-effectiveness analysis of each intervention arm as compared to Usual Care. If proven effective, this research will yield low literacy diabetes and CVD patient education and self-management intervention tools for dissemination to high-risk urban minority populations. Moreover, the cost-effectiveness analysis will provide evidence to support decision-making regarding implementation of the models to achieve cardiovascular disease patient self-management goals in clinical practice.

Type d'étude

Interventionnel

Inscription (Réel)

382

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Baltimore, Maryland, États-Unis, 21205
        • Johns Hopkins School of Medicine/General Clinical Research Center
      • Baltimore, Maryland, États-Unis, 21224
        • Johns Hopkins Bayview Medical Center/General Clinical Research Center
      • Baltimore, Maryland, États-Unis, 21287
        • Johns Hopkins School of Medicine/General Internal Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age 25 years or older

    • Type 2 diabetes determined by physician diagnosis or self-report of type 2 diabetes confirmed by medical documentation or medication review
    • Black/African American by self-report
    • currently receiving care and able to provide contact information for a treating physician
    • residing in Baltimore, Maryland.

Exclusion Criteria:

  • Mentally incompetent to give informed consent
  • Severe cognitive impairment on the Telephone Interview for Cognitive Status
  • Unable to complete assessment (interview, tests, venipuncture)
  • Comorbid conditions likely to lead to death in the next 3-5 years (e.g. cancer, AIDS, end-stage renal disease, active tuberculosis, Alzheimer's disease)
  • Planning to relocate from Baltimore region during the time period of the study or other reasons rendering person unable to attend visits to participate in intervention and follow-up assessments

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Usual Care
Packet of standard print patient education materials on CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA).
  • Packet of print patient education materials about CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA)given at baseline following randomization to Arm 1
  • Scripted set of instructions will be given along with a verbal description of the materials and the content provided.
Autres noms:
  • Standard Print Education Materials
  • Project DECIDE Usual Care
Expérimental: Self Study
One 90-minute educational session. Print materials and DVDs for self-study
  • Education + Problem-Solving Training Self-Study
  • One session of Literacy-Adapted Diabetes and CVD Risk Education
  • Instructions and a schedule for use of the Literacy-Adapted Problem-Solving Workbook for self-study will be given to each participant.
Autres noms:
  • Self-Management Training Self-Study
  • Project DECIDE Self-Study
Expérimental: Group Problem-Solving Training
One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)
  • Education + Group Problem-Solving Training
  • One session of the Literacy-Adapted Diabetes and CVD Risk Education
  • Group problem-solving training eight, 90-minute sessions
Autres noms:
  • Group Self-Management Training
  • Project DECIDE Group Training
Expérimental: Individual Problem-Solving Training
One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)
  • Education + Individual Problem-Solving Training
  • One session of the Literacy-Adapted Diabetes and CVD Risk Education
  • Individual problem-solving training (eight, 60-minute sessions)
Autres noms:
  • Individual Self-Management Training
  • Project DECIDE Individual Training

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
HbA1C
Délai: Screening, 3 months post intervention, 6 months post-intervention
Screening, 3 months post intervention, 6 months post-intervention

Mesures de résultats secondaires

Mesure des résultats
Délai
Blood pressure
Délai: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Lipid Panel
Délai: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index
Délai: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Health Problem Solving Scale
Délai: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Diabetes and CVD Knowledge Test
Délai: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Patient Activation Measure
Délai: Baseline, 3 months post-intervention, 6 months post-intervention
Baseline, 3 months post-intervention, 6 months post-intervention
Summary of Diabetes Self-Care Activities Scale
Délai: Baseline, 3 months post-intervention, 6 months post-intervention
Baseline, 3 months post-intervention, 6 months post-intervention
Barriers to Self-Management
Délai: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Felicia Hill-Briggs, PhD, ABPP, Johns Hopkins School of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2010

Achèvement primaire (Réel)

1 février 2014

Achèvement de l'étude (Réel)

1 février 2014

Dates d'inscription aux études

Première soumission

24 août 2009

Première soumission répondant aux critères de contrôle qualité

24 août 2009

Première publication (Estimation)

25 août 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2015

Dernière vérification

1 mai 2015

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Diabète de type 2

Essais cliniques sur Usual Care

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