Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Felicia Hill-Briggs, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00201110
First received: September 16, 2005
Last updated: March 19, 2013
Last verified: March 2013

September 16, 2005
March 19, 2013
July 2004
May 2009   (final data collection date for primary outcome measure)
A1C [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00201110 on ClinicalTrials.gov Archive Site
  • Barriers to Self-Management [ Time Frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
  • Dietary risk assessment [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
  • Summary of Diabetes Self-Care Activities Scale [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
  • Health Problem-Solving Scale [ Time Frame: baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
  • Diabetes and CVD Knowledge Test [ Time Frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]
  • Lipid panel [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
Problem Solving & CVD 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Heart Diseases
  • Diabetes Mellitus, Type 2
  • Coronary Disease
  • Behavioral: Problem Solving Skills
    Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
  • Behavioral: Problem Solving Skills
    Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
  • Experimental: 1
    Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
    Intervention: Behavioral: Problem Solving Skills
  • Active Comparator: 2
    Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
    Intervention: Behavioral: Problem Solving Skills

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
June 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201110
274, K01HL076644, K01 HL76644
Yes
Felicia Hill-Briggs, Johns Hopkins University
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Felicia Hill-Briggs, PhD Johns Hopkins University
Johns Hopkins University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP