ClinicalTrials.Veeva

Menu

Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

Johns Hopkins University logo

Johns Hopkins University

Status

Completed

Conditions

Cardiovascular Diseases
Diabetes Mellitus, Type 2
Coronary Disease
Heart Diseases

Treatments

Behavioral: Problem Solving Skills

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00201110
K01HL076644 (U.S. NIH Grant/Contract)
274

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

139 participants in 2 patient groups

1
Experimental group
Description:
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Treatment:
Behavioral: Problem Solving Skills
Behavioral: Problem Solving Skills
2
Active Comparator group
Description:
Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
Treatment:
Behavioral: Problem Solving Skills
Behavioral: Problem Solving Skills

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems