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Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

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ClinicalTrials.gov Identifier: NCT00201110
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 20, 2013
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Felicia Hill-Briggs, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Diabetes Mellitus, Type 2 Coronary Disease Behavioral: Problem Solving Skills Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Problem Solving & CVD Risk Management in Diabetic Blacks
Study Start Date : July 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Behavioral: Problem Solving Skills
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)

Active Comparator: 2
Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
Behavioral: Problem Solving Skills
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)




Primary Outcome Measures :
  1. A1C [ Time Frame: Baseline, 3-month post-intervention follow-up ]

Secondary Outcome Measures :
  1. Barriers to Self-Management [ Time Frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ]
  2. Dietary risk assessment [ Time Frame: Baseline, 3-month post-intervention follow-up ]
  3. Summary of Diabetes Self-Care Activities Scale [ Time Frame: Baseline, 3-month post-intervention follow-up ]
  4. Health Problem-Solving Scale [ Time Frame: baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ]
  5. Diabetes and CVD Knowledge Test [ Time Frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ]
  6. Blood pressure [ Time Frame: Baseline, 3-month post-intervention follow-up ]
  7. Lipid panel [ Time Frame: Baseline, 3-month post-intervention follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201110


Locations
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United States, Maryland
Johns Hopkins School of Medicine/General Clinical Research Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Felicia Hill-Briggs, PhD Johns Hopkins University
Publications of Results:
Other Publications:
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Responsible Party: Felicia Hill-Briggs, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00201110    
Other Study ID Numbers: 274
K01HL076644 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013
Keywords provided by Felicia Hill-Briggs, Johns Hopkins University:
African Americans
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Vascular Diseases