- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00201110
Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
Problem Solving & CVD Risk Management in Diabetic Blacks
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21205
- Johns Hopkins School of Medicine/General Clinical Research Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
|
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)
|
Aktiver Komparator: 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)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
A1C
Zeitfenster: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Barriers to Self-Management
Zeitfenster: 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
Zeitfenster: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Summary of Diabetes Self-Care Activities Scale
Zeitfenster: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Health Problem-Solving Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Lipid panel
Zeitfenster: Baseline, 3-month post-intervention follow-up
|
Baseline, 3-month post-intervention follow-up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Felicia Hill-Briggs, PhD, Johns Hopkins University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 274
- K01HL076644 (US NIH Stipendium/Vertrag)
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