Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
Problem Solving & CVD Risk Management in Diabetic Blacks
2 other identifiers
interventional
139
1 country
1
Brief Summary
The purpose of this study is to test a measurement tool and a new training intervention for problem solving in self-management of high cardiovascular disease (CVD) risk in African Americans with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Jul 2004
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 20, 2013
March 1, 2013
4.8 years
September 16, 2005
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A1C
Baseline, 3-month post-intervention follow-up
Secondary Outcomes (7)
Barriers to Self-Management
Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Dietary risk assessment
Baseline, 3-month post-intervention follow-up
Summary of Diabetes Self-Care Activities Scale
Baseline, 3-month post-intervention follow-up
Health Problem-Solving Scale
baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Diabetes and CVD Knowledge Test
Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALIntensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
2
ACTIVE COMPARATORBrief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
Interventions
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Plan to leave area prior to study completion
- Severe diabetes complications that would interfere with the study
- End-stage disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins School of Medicine/General Clinical Research Center
Baltimore, Maryland, 21205, United States
Related Publications (6)
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.
PMID: 18057272BACKGROUNDHill-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.
PMID: 18202245BACKGROUNDHill-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.
PMID: 17443373BACKGROUNDHill-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.
BACKGROUNDHill-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.
PMID: 18521688BACKGROUNDHill-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.
PMID: 21445680RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felicia Hill-Briggs, PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
July 1, 2004
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
March 20, 2013
Record last verified: 2013-03