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
  Purpose

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 Intervention
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Type 2
Coronary Disease
Behavioral: Problem Solving Skills

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Problem Solving & CVD Risk Management in Diabetic Blacks

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • A1C [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 139
Study Start Date: July 2004
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201110

Locations
United States, Maryland
Johns Hopkins School of Medicine/General Clinical Research Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Felicia Hill-Briggs, PhD Johns Hopkins University
  More Information

Publications:
Responsible Party: Felicia Hill-Briggs, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00201110     History of Changes
Other Study ID Numbers: 274, K01HL076644, K01 HL76644
Study First Received: September 16, 2005
Last Updated: March 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
African Americans

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014