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Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Skills
Problem Solving Skills
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring African Americans

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins School of Medicine/General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

A1C

Secondary Outcome Measures

Barriers to Self-Management
Dietary risk assessment
Summary of Diabetes Self-Care Activities Scale
Health Problem-Solving Scale
Diabetes and CVD Knowledge Test
Blood pressure
Lipid panel

Full Information

First Posted
September 16, 2005
Last Updated
March 19, 2013
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00201110
Brief Title
Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
Official Title
Problem Solving & CVD Risk Management in Diabetic Blacks
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2, Coronary Disease
Keywords
African Americans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Skills
Intervention Description
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Skills
Intervention Description
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
Primary Outcome Measure Information:
Title
A1C
Time Frame
Baseline, 3-month post-intervention follow-up
Secondary Outcome Measure Information:
Title
Barriers to Self-Management
Time Frame
Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Title
Dietary risk assessment
Time Frame
Baseline, 3-month post-intervention follow-up
Title
Summary of Diabetes Self-Care Activities Scale
Time Frame
Baseline, 3-month post-intervention follow-up
Title
Health Problem-Solving Scale
Time Frame
baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Title
Diabetes and CVD Knowledge Test
Time Frame
Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Title
Blood pressure
Time Frame
Baseline, 3-month post-intervention follow-up
Title
Lipid panel
Time Frame
Baseline, 3-month post-intervention follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicia Hill-Briggs, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine/General Clinical Research Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18057272
Citation
Hill-Briggs F, Gemmell L. Problem solving in diabetes self-management and control: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1032-50; discussion 1051-2. doi: 10.1177/0145721707308412.
Results Reference
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PubMed Identifier
18202245
Citation
Hill-Briggs F, Smith AS. Evaluation of diabetes and cardiovascular disease print patient education materials for use with low-health literate populations. Diabetes Care. 2008 Apr;31(4):667-71. doi: 10.2337/dc07-1365. Epub 2008 Jan 17.
Results Reference
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PubMed Identifier
17443373
Citation
Hill-Briggs F, Gemmell L, Kulkarni B, Klick B, Brancati FL. Associations of patient health-related problem solving with disease control, emergency department visits, and hospitalizations in HIV and diabetes clinic samples. J Gen Intern Med. 2007 May;22(5):649-54. doi: 10.1007/s11606-006-0091-2.
Results Reference
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Citation
Hill-Briggs F, Lazo M, Renosky R, Ewing C. Usability of diabetes and cardiovascular disease education module in an African-American, diabetic sample with physical, visual, and cognitive impairment. Rehabilitation Psychology, 2008;53:1-8.
Results Reference
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PubMed Identifier
18521688
Citation
Hill-Briggs F, Renosky R, Lazo M, Bone L, Hill M, Levine D, Brancati FL, Peyrot M. Development and pilot evaluation of literacy-adapted diabetes and CVD education in urban, diabetic African Americans. J Gen Intern Med. 2008 Sep;23(9):1491-4. doi: 10.1007/s11606-008-0679-9. Epub 2008 Jun 3.
Results Reference
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PubMed Identifier
21445680
Citation
Hill-Briggs F, Lazo M, Peyrot M, Doswell A, Chang YT, Hill MN, Levine D, Wang NY, Brancati FL. Effect of problem-solving-based diabetes self-management training on diabetes control in a low income patient sample. J Gen Intern Med. 2011 Sep;26(9):972-8. doi: 10.1007/s11606-011-1689-6. Epub 2011 Mar 29.
Results Reference
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Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

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