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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 人开始时间: 2004年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
A1C

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

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

研究组 & 干预措施

1

Experimental

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

干预措施: Problem Solving Skills (Behavioral)

2

Active Comparator

Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)

干预措施: Problem Solving Skills (Behavioral)

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felicia Hill-Briggs

Principal Investigator

Johns Hopkins University

研究点 (1)

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