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Completed

NCT Number: NCT00201110

Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine/General Clinical Research Center

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem Solving Skills

Behavioral

Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)

Primary outcomes

  1. A1C

    Time frame: Baseline, 3-month post-intervention follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Problem Solving & CVD Risk Management in Diabetic Blacks

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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