跳至主要内容
临床试验/NCT00201110
NCT00201110
已完成
不适用

Problem Solving & CVD Risk Management in Diabetic Blacks

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 139 人2004年7月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Cardiovascular Diseases
发起方
Johns Hopkins University
入组人数
139
试验地点
1
主要终点
A1C
状态
已完成
最后更新
13年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2004年7月
结束日期
2009年6月
最后更新
13年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Felicia Hill-Briggs

Principal Investigator

Johns Hopkins University

入排标准

入选标准

  • 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

排除标准

  • Plan to leave area prior to study completion
  • Severe diabetes complications that would interfere with the study
  • End-stage disease

结局指标

主要结局

A1C

时间窗: Baseline, 3-month post-intervention follow-up

次要结局

  • Barriers to Self-Management(Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up)
  • Dietary risk assessment(Baseline, 3-month post-intervention follow-up)
  • Summary of Diabetes Self-Care Activities Scale(Baseline, 3-month post-intervention follow-up)
  • Health Problem-Solving Scale(baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up)
  • Diabetes and CVD Knowledge Test(Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up)
  • Blood pressure(Baseline, 3-month post-intervention follow-up)
  • Lipid panel(Baseline, 3-month post-intervention follow-up)

研究点 (1)

Loading locations...

相似试验