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

11 maggio 2015 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

382

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

25 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altri nomi:
  • Standard Print Education Materials
  • Project DECIDE Usual Care
Sperimentale: 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.
Altri nomi:
  • Self-Management Training Self-Study
  • Project DECIDE Self-Study
Sperimentale: 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
Altri nomi:
  • Group Self-Management Training
  • Project DECIDE Group Training
Sperimentale: 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)
Altri nomi:
  • Individual Self-Management Training
  • Project DECIDE Individual Training

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
HbA1C
Lasso di tempo: Screening, 3 months post intervention, 6 months post-intervention
Screening, 3 months post intervention, 6 months post-intervention

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Blood pressure
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Lipid Panel
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Health Problem Solving Scale
Lasso di tempo: 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
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Patient Activation Measure
Lasso di tempo: 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
Lasso di tempo: Baseline, 3 months post-intervention, 6 months post-intervention
Baseline, 3 months post-intervention, 6 months post-intervention
Barriers to Self-Management
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Felicia Hill-Briggs, PhD, ABPP, Johns Hopkins School of Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2010

Completamento primario (Effettivo)

1 febbraio 2014

Completamento dello studio (Effettivo)

1 febbraio 2014

Date di iscrizione allo studio

Primo inviato

24 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità

24 agosto 2009

Primo Inserito (Stima)

25 agosto 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 maggio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2015

Ultimo verificato

1 maggio 2015

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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