- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00201110
Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
Problem Solving & CVD Risk Management in Diabetic Blacks
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
BACKGROUND:
African Americans with type 2 diabetes carry a high burden of CVD risk and adverse vascular events such as stroke and peripheral vascular disease. CVD risk factors of suboptimal blood pressure, lipids, and glycemic control are controllable through medical management and lifestyle behavior modification. The traditional primary care medical management model for these chronic CVD risks is inadequate, and models are shifting toward increased disease-related decision-making and self-management on the part of the patient. Yet, precise methods for: 1) identifying patients with ineffective disease-related problem-solving skills, and 2) providing patients with disease-related education that incorporates problem-solving and decision-making skills, have yet to be determined
DESIGN NARRATIVE:
The study will test a measurement tool and a novel training intervention for problem solving as applied to self-management of high CVD risk in African Americans with type 2 diabetes. The specific aims are to: 1) assess the validity and reliability of an empirically derived assessment tool of effective versus ineffective CVD risk-related problem-solving ability (the Health Problem Solving Scale, HPSS), 2) develop a novel intervention to teach CVD risk-related problem-solving skills to ineffective problem solvers, and 3) conduct a pilot study with a sample of African Americans with type 2 diabetes who have a high CVD risk profile (suboptimal blood pressure, lipids, and/or HbA1c) AND ineffective CVD risk-related problem-solving skills, as measured by the HPSS. The principal investigator is the recipient of a Research Scientist Development Award. Her career goal is to become an independent researcher in self-management of CVD risk in high-risk African American populations, and to be a leader in the development and translation into practice of novel, theory-driven and empirically based interventions to improve patient self-management of CVD risks.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
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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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of type 2 diabetes
- African American by self report
- High CVD risk profile, defined as having one or more of the following:1) suboptimal A1C (greater than 7 percent); 2) suboptimal blood pressure (SBP greater than 130 mmHg and/or DBP greater than 80 mmHg); 3) suboptimal lipid control (LDL greater than 100 mg and/or HDL less than 40 mg)
- Willing and able to give informed consent
Exclusion Criteria:
- Plan to leave area prior to study completion
- Severe diabetes complications that would interfere with the study
- End-stage disease
Piano di studio
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 |
|---|---|
|
Sperimentale: 1
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
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Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
|
|
Comparatore attivo: 2
Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
|
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
A1C
Lasso di tempo: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Barriers to Self-Management
Lasso di tempo: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
|
Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
|
|
Dietary risk assessment
Lasso di tempo: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
|
Summary of Diabetes Self-Care Activities Scale
Lasso di tempo: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
|
Health Problem-Solving Scale
Lasso di tempo: baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
|
baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
|
|
Diabetes and CVD Knowledge Test
Lasso di tempo: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
|
Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
|
|
Blood pressure
Lasso di tempo: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
|
Lipid panel
Lasso di tempo: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Felicia Hill-Briggs, PhD, Johns Hopkins University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Hill-Briggs F, Lazo M, Renosky R, Ewing C. Usability of diabetes and cardiovascular disease education module in an African-American, diabetic sample with physical, visual, and cognitive impairment. Rehabilitation Psychology, 2008;53:1-8.
- Hill-Briggs F, Lazo M, Peyrot M, Doswell A, Chang YT, Hill MN, Levine D, Wang NY, Brancati FL. Effect of problem-solving-based diabetes self-management training on diabetes control in a low income patient sample. J Gen Intern Med. 2011 Sep;26(9):972-8. doi: 10.1007/s11606-011-1689-6. Epub 2011 Mar 29.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 274
- K01HL076644 (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 .
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