Cardiovascular DiseasesNCT00201110
Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
A study testing Problem Solving Skills in people with Cardiovascular Diseases and Heart Diseases, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Problem Solving Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Plan to leave area prior to study completion
- Severe diabetes complications that would interfere with the study
- End-stage disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine/General Clinical Research Center
Baltimore, Maryland, 21205
About this study
Official title: 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.
Read the 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.
- Being tested
- Problem Solving Skills
- Keywords
- African Americans
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving SkillsBehavioural
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
Problem Solving SkillsBehavioural
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions) Receives: Behavioral: Problem Solving Skills |
| 2 | Active comparator | Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session) Receives: Behavioral: Problem Solving Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C
Measured: Baseline, 3-month post-intervention follow-up
Secondary outcomes (7)
Barriers to Self-Management
Measured: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Dietary risk assessment
Measured: Baseline, 3-month post-intervention follow-up
Summary of Diabetes Self-Care Activities Scale
Measured: Baseline, 3-month post-intervention follow-up
Health Problem-Solving Scale
Measured: baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Diabetes and CVD Knowledge Test
Measured: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Blood pressure
Measured: Baseline, 3-month post-intervention follow-up
Lipid panel
Measured: Baseline, 3-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Felicia Hill-Briggs, Johns Hopkins University
- Investigators
- Felicia Hill-Briggs, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201110
- Sponsor's protocol ID
- 274
- Other IDs
- K01HL076644
- Status last verified
- Mar 2013
- First submitted
- 16 Sep 2005
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18057272Hill-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.
PubMed 18202245Hill-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.
PubMed 17443373Hill-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.
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.
PubMed 18521688Hill-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.
PubMed 21445680
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Solving & CVD Risk Management in Diabetic Blacks
- ClinicalTrials.gov ID
- NCT00201110
- Acronym / sponsor ID
- 274
- Keywords
- African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2004
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Problem Solving SkillsIntensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions) |
| 2 | Active comparator | Behavioral: Problem Solving SkillsBrief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Plan to leave area prior to study completion
- Severe diabetes complications that would interfere with the study
- End-stage disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving SkillsIntensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions) | Behavioural | 1 |
| Problem Solving SkillsBrief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session) | Behavioural | 2 |
Primary outcome
A1C
Time frame: Baseline, 3-month post-intervention follow-up
7 secondary outcomes
Barriers to Self-Management
Time frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Dietary risk assessment
Time frame: Baseline, 3-month post-intervention follow-up
Summary of Diabetes Self-Care Activities Scale
Time frame: Baseline, 3-month post-intervention follow-up
Health Problem-Solving Scale
Time frame: baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Diabetes and CVD Knowledge Test
Time frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up
Blood pressure
Time frame: Baseline, 3-month post-intervention follow-up
Lipid panel
Time frame: Baseline, 3-month post-intervention follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Background: PubMed 18057272Hill-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.
- Background: PubMed 18202245Hill-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.
- Background: PubMed 17443373Hill-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.
- BackgroundHill-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.
- Background: PubMed 18521688Hill-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 publication: PubMed 21445680Hill-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicia Hill-Briggs, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Skills in people with Cardiovascular Diseases and Heart Diseases, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1C (time frame: Baseline, 3-month post-intervention follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201110, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.