- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00964587
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
Stato
Completato
Condizioni
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
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins School of Medicine/General Clinical Research Center
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Baltimore, Maryland, Stati Uniti, 21224
- Johns Hopkins Bayview Medical Center/General Clinical Research Center
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins School of Medicine/General Internal Medicine
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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 |
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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).
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Altri nomi:
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Sperimentale: Self Study
One 90-minute educational session.
Print materials and DVDs for self-study
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Altri nomi:
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Sperimentale: Group Problem-Solving Training
One 90-minute education session.
Group problem-solving training (eight, 90-minute sessions)
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Altri nomi:
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Sperimentale: Individual Problem-Solving Training
One 90-minute education session.
Individual problem-solving training (eight, 60-minute sessions)
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Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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HbA1C
Lasso di tempo: Screening, 3 months post intervention, 6 months post-intervention
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Screening, 3 months post intervention, 6 months post-intervention
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Blood pressure
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Lipid Panel
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Body Mass Index
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Health Problem Solving Scale
Lasso di tempo: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Diabetes and CVD Knowledge Test
Lasso di tempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Patient Activation Measure
Lasso di tempo: Baseline, 3 months post-intervention, 6 months post-intervention
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Baseline, 3 months post-intervention, 6 months post-intervention
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Summary of Diabetes Self-Care Activities Scale
Lasso di tempo: Baseline, 3 months post-intervention, 6 months post-intervention
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Baseline, 3 months post-intervention, 6 months post-intervention
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Barriers to Self-Management
Lasso di tempo: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
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
- Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.
- Hill-Briggs F, Gemmell L. Problem solving in diabetes self-management and control: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1032-50; discussion 1051-2. doi: 10.1177/0145721707308412.
- Hill-Briggs F, Smith AS. Evaluation of diabetes and cardiovascular disease print patient education materials for use with low-health literate populations. Diabetes Care. 2008 Apr;31(4):667-71. doi: 10.2337/dc07-1365. Epub 2008 Jan 17.
- Hill-Briggs F, Gemmell L, Kulkarni B, Klick B, Brancati FL. Associations of patient health-related problem solving with disease control, emergency department visits, and hospitalizations in HIV and diabetes clinic samples. J Gen Intern Med. 2007 May;22(5):649-54. doi: 10.1007/s11606-006-0091-2.
- Hill-Briggs F, Renosky R, Lazo M, Bone L, Hill M, Levine D, Brancati FL, Peyrot M. Development and pilot evaluation of literacy-adapted diabetes and CVD education in urban, diabetic African Americans. J Gen Intern Med. 2008 Sep;23(9):1491-4. doi: 10.1007/s11606-008-0679-9. Epub 2008 Jun 3.
- Majid HM, Schumann KP, Doswell A, Sutherland J, Hill Golden S, Stewart KJ, Hill-Briggs F. Development and evaluation of the DECIDE to move! Physical activity educational video. Diabetes Educ. 2012 Nov-Dec;38(6):855-9. doi: 10.1177/0145721712462748. Epub 2012 Oct 4. Erratum In: Diabetes Educ. 2013 Jul-Aug;39(4):586.
- Hill-Briggs F, Schumann KP, Dike O. Five-step methodology for evaluation and adaptation of print patient health information to meet the < 5th grade readability criterion. Med Care. 2012 Apr;50(4):294-301. doi: 10.1097/MLR.0b013e318249d6c8.
- Fitzpatrick SL, Schumann KP, Hill-Briggs F. Problem solving interventions for diabetes self-management and control: a systematic review of the literature. Diabetes Res Clin Pract. 2013 May;100(2):145-61. doi: 10.1016/j.diabres.2012.12.016. Epub 2013 Jan 9.
- Fitzpatrick SL, Golden SH, Stewart K, Sutherland J, DeGross S, Brown T, Wang NY, Allen J, Cooper LA, Hill-Briggs F. Effect of DECIDE (Decision-making Education for Choices In Diabetes Everyday) Program Delivery Modalities on Clinical and Behavioral Outcomes in Urban African Americans With Type 2 Diabetes: A Randomized Trial. Diabetes Care. 2016 Dec;39(12):2149-2157. doi: 10.2337/dc16-0941.
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01HL089751-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .