NCT00964587

Brief Summary

The purpose of this study is to determine if patient education and problem-solving training, delivered in self-study, group, and individual intervention modalities, will produce substantial improvements in CVD risk profile via improved self management in urban African Americans with type 2 diabetes and a high CVD risk profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

August 24, 2009

Last Update Submit

May 11, 2015

Conditions

Type 2 Diabetes

Keywords

diabetes self management educationproblem-solving traininghealth behavior changehealth literacy

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    Screening, 3 months post intervention, 6 months post-intervention

Secondary Outcomes (8)

  • Blood pressure

    Screening, 3 months post-intervention, 6 months post-intervention

  • Lipid Panel

    Screening, 3 months post-intervention, 6 months post-intervention

  • Body Mass Index

    Screening, 3 months post-intervention, 6 months post-intervention

  • Health Problem Solving Scale

    Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention

  • Diabetes and CVD Knowledge Test

    Screening, 3 months post-intervention, 6 months post-intervention

  • +3 more secondary outcomes

Study Arms (4)

Usual Care

ACTIVE COMPARATOR

Packet of standard print patient education materials on CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA).

Behavioral: Usual Care

Self Study

EXPERIMENTAL

One 90-minute educational session. Print materials and DVDs for self-study

Behavioral: Education + Problem-Solving Training Self-Study

Group Problem-Solving Training

EXPERIMENTAL

One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)

Behavioral: Education + Group Problem-Solving Training

Individual Problem-Solving Training

EXPERIMENTAL

One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)

Behavioral: Education + Individual Problem-Solving Training

Interventions

Education + Problem-Solving Training Self-StudyBEHAVIORAL

* Education + Problem-Solving Training Self-Study * One session of Literacy-Adapted Diabetes and CVD Risk Education * Instructions and a schedule for use of the Literacy-Adapted Problem-Solving Workbook for self-study will be given to each participant.

Also known as: Self-Management Training Self-Study, Project DECIDE Self-Study
Self Study
Education + Group Problem-Solving TrainingBEHAVIORAL

* Education + Group Problem-Solving Training * One session of the Literacy-Adapted Diabetes and CVD Risk Education * Group problem-solving training eight, 90-minute sessions

Also known as: Group Self-Management Training, Project DECIDE Group Training
Group Problem-Solving Training
Education + Individual Problem-Solving TrainingBEHAVIORAL

* Education + Individual Problem-Solving Training * One session of the Literacy-Adapted Diabetes and CVD Risk Education * Individual problem-solving training (eight, 60-minute sessions)

Also known as: Individual Self-Management Training, Project DECIDE Individual Training
Individual Problem-Solving Training
Usual CareBEHAVIORAL

* Packet of print patient education materials about CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA)given at baseline following randomization to Arm 1 * Scripted set of instructions will be given along with a verbal description of the materials and the content provided.

Also known as: Standard Print Education Materials, Project DECIDE Usual Care
Usual Care

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25 years or older
  • Type 2 diabetes determined by physician diagnosis or self-report of type 2 diabetes confirmed by medical documentation or medication review
  • Black/African American by self-report
  • currently receiving care and able to provide contact information for a treating physician
  • residing in Baltimore, Maryland.

You may not qualify if:

  • Mentally incompetent to give informed consent
  • Severe cognitive impairment on the Telephone Interview for Cognitive Status
  • Unable to complete assessment (interview, tests, venipuncture)
  • Comorbid conditions likely to lead to death in the next 3-5 years (e.g. cancer, AIDS, end-stage renal disease, active tuberculosis, Alzheimer's disease)
  • Planning to relocate from Baltimore region during the time period of the study or other reasons rendering person unable to attend visits to participate in intervention and follow-up assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins School of Medicine/General Clinical Research Center

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bayview Medical Center/General Clinical Research Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins School of Medicine/General Internal Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (9)

  • 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.

    PMID: 18057272BACKGROUND

  • 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.

    PMID: 18202245BACKGROUND

  • 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.

    PMID: 17443373BACKGROUND

  • Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.

    PMID: 12763713BACKGROUND

  • 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.

    PMID: 18521688BACKGROUND

  • Majid HM, Schumann KP, Doswell A, Sutherland J, Hill Golden S, Stewart KJ, Hill-Briggs F. Development and evaluation of the DECIDE to move! Physical activity educational video. Diabetes Educ. 2012 Nov-Dec;38(6):855-9. doi: 10.1177/0145721712462748. Epub 2012 Oct 4.

    PMID: 23042504BACKGROUND

  • Hill-Briggs F, Schumann KP, Dike O. Five-step methodology for evaluation and adaptation of print patient health information to meet the < 5th grade readability criterion. Med Care. 2012 Apr;50(4):294-301. doi: 10.1097/MLR.0b013e318249d6c8.

    PMID: 22354210BACKGROUND

  • Fitzpatrick SL, Schumann KP, Hill-Briggs F. Problem solving interventions for diabetes self-management and control: a systematic review of the literature. Diabetes Res Clin Pract. 2013 May;100(2):145-61. doi: 10.1016/j.diabres.2012.12.016. Epub 2013 Jan 9.

    PMID: 23312614BACKGROUND

  • Fitzpatrick SL, Golden SH, Stewart K, Sutherland J, DeGross S, Brown T, Wang NY, Allen J, Cooper LA, Hill-Briggs F. Effect of DECIDE (Decision-making Education for Choices In Diabetes Everyday) Program Delivery Modalities on Clinical and Behavioral Outcomes in Urban African Americans With Type 2 Diabetes: A Randomized Trial. Diabetes Care. 2016 Dec;39(12):2149-2157. doi: 10.2337/dc16-0941.

    PMID: 27879359DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Felicia Hill-Briggs, PhD, ABPP

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor of Medicine

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

August 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

US(3)