Type 2 DiabetesDECIDENCT00964587
Cardiovascular Disease Education and Problem-Solving Training in People With Type 2 Diabetes
A study testing Education + Problem-Solving Training Self-Study, Education + Group Problem-Solving Training and Education + Individual Problem-Solving Training in people with Type 2 Diabetes, run by Johns Hopkins University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Education + Problem-Solving Training Self-Study, Education + Group Problem-Solving Training and Education + Individual Problem-Solving Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Feb 2014
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins School of Medicine/General Clinical Research Center
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center/General Clinical Research Center
Baltimore, Maryland, 21224
Johns Hopkins School of Medicine/General Internal Medicine
Baltimore, Maryland, 21287
About this study
Official title: Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics
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.
Read the detailed description
African Americans with type 2 diabetes suffer excess disease burden, but cardiovascular disease (CVD) risk factors such as hyperglycemia, hypertension, and dyslipidemia are modifiable with medical management and lifestyle modification. Patient diabetes education and counseling for behavior change are recommended standards of practice to facilitate effective self-management of these risk factors. However, for patients with low literacy or health literacy, accessibility and impact of educational and behavioral interventions are limited. Pilot research suggests that: a) literacy demand and behavioral activation characteristics of patient education modules can be adapted to facilitate learning in urban patients with low literacy, and b) combining literacy-adapted education with problem-solving training facilitates understanding and use of health information for performing self-management in the context of daily life (functional health literacy). Optimal modalities for delivery of a combined patient diabetes education and problem-solving training, and cost-effectiveness of this intervention model, however, are not known. The proposed study will address these needs by testing effectiveness and cost-effectiveness of literacy-adapted diabetes and CVD education and problem-solving training interventions in urban African Americans with type 2 diabetes and high CVD risk profile (suboptimal blood sugar, blood pressure, and/or lipids). The specific aims of the study are: a) to complete development of a package of literacy-adapted diabetes and CVD patient education materials by developing two video/DVDs addressing self-management recommendations appropriate to the needs, resources, and environment of the population; b) to randomize urban African-American adults with type 2 diabetes and a high CVD risk profile into one of four study arms: Usual Care (Arm 1), Literacy-Adapted Education and Problem-Solving Training Self-Study (Arm 2), Literacy-Adapted Education and Group Problem-Solving Training (Arm 3), and Literacy-Adapted Education and Individual Problem-Solving Training (Arm 4); c) to conduct baseline, 3-month post-intervention, and 6-month post-intervention assessment visits to analyze and compare effectiveness of the literacy-adapted education and problem-solving interventions, as compared to Usual Care, in improving the skills of knowledge, problem-solving and health literacy, behaviors of patient activation and diabetes self-management, and clinical outcomes of A1C, blood pressure and lipids; and d) to perform a cost-effectiveness analysis of each intervention arm as compared to Usual Care. If proven effective, this research will yield low literacy diabetes and CVD patient education and self-management intervention tools for dissemination to high-risk urban minority populations. Moreover, the cost-effectiveness analysis will provide evidence to support decision-making regarding implementation of the models to achieve cardiovascular disease patient self-management goals in clinical practice.
- Conditions
- Type 2 Diabetes
- Being tested
- Education + Problem-Solving Training Self-Study, Education + Group Problem-Solving Training, Education + Individual Problem-Solving Training, Usual Care
- Keywords
- diabetes self management education, problem-solving training, health behavior change, health literacy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education + Problem-Solving Training Self-StudyBehavioural
Also called Self-Management Training Self-Study, Project DECIDE Self-Study
- 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.
Education + Group Problem-Solving TrainingBehavioural
Also called Group Self-Management Training, Project DECIDE Group Training
- Education + Group Problem-Solving Training
- One session of the Literacy-Adapted Diabetes and CVD Risk Education
- Group problem-solving training eight, 90-minute sessions
Education + Individual Problem-Solving TrainingBehavioural
Also called Individual Self-Management Training, Project DECIDE Individual Training
- Education + Individual Problem-Solving Training
- One session of the Literacy-Adapted Diabetes and CVD Risk Education
- Individual problem-solving training (eight, 60-minute sessions)
Usual CareBehavioural
Also called Standard Print Education Materials, Project DECIDE Usual Care
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Usual Care |
| Self Study | Experimental | One 90-minute educational session. Print materials and DVDs for self-study Receives: 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) Receives: Behavioral: Education + Group Problem-Solving Training |
| Individual Problem-Solving Training | Experimental | One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions) Receives: Behavioral: Education + Individual Problem-Solving Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: Screening, 3 months post intervention, 6 months post-intervention
Secondary outcomes (8)
Blood pressure
Measured: Screening, 3 months post-intervention, 6 months post-intervention
Lipid Panel
Measured: Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index
Measured: Screening, 3 months post-intervention, 6 months post-intervention
Health Problem Solving Scale
Measured: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Diabetes and CVD Knowledge Test
Measured: Screening, 3 months post-intervention, 6 months post-intervention
Patient Activation Measure
Measured: Baseline, 3 months post-intervention, 6 months post-intervention
Summary of Diabetes Self-Care Activities Scale
Measured: Baseline, 3 months post-intervention, 6 months post-intervention
Barriers to Self-Management
Measured: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 382 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, ABPP, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964587
- Sponsor's protocol ID
- R01HL089751-01A1
- Other IDs
- R01HL089751-01A1
- Acronym
- DECIDE
- Status last verified
- May 2015
- First submitted
- 24 Aug 2009
- Last updated
- 12 May 2015
- 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. 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.
PubMed 12763713Hill-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 18521688Majid 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.
PubMed 23042504Hill-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.
PubMed 22354210Fitzpatrick 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.
PubMed 23312614Fitzpatrick 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.
PubMed 27879359
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics
- ClinicalTrials.gov ID
- NCT00964587
- Acronym / sponsor ID
- DECIDE / R01HL089751-01A1
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes self management education, problem-solving training, health behavior change, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Aug 2009 (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 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.
Detailed description
African Americans with type 2 diabetes suffer excess disease burden, but cardiovascular disease (CVD) risk factors such as hyperglycemia, hypertension, and dyslipidemia are modifiable with medical management and lifestyle modification. Patient diabetes education and counseling for behavior change are recommended standards of practice to facilitate effective self-management of these risk factors. However, for patients with low literacy or health literacy, accessibility and impact of educational and behavioral interventions are limited. Pilot research suggests that: a) literacy demand and behavioral activation characteristics of patient education modules can be adapted to facilitate learning in urban patients with low literacy, and b) combining literacy-adapted education with problem-solving training facilitates understanding and use of health information for performing self-management in the context of daily life (functional health literacy). Optimal modalities for delivery of a combined patient diabetes education and problem-solving training, and cost-effectiveness of this intervention model, however, are not known. The proposed study will address these needs by testing effectiveness and cost-effectiveness of literacy-adapted diabetes and CVD education and problem-solving training interventions in urban African Americans with type 2 diabetes and high CVD risk profile (suboptimal blood sugar, blood pressure, and/or lipids). The specific aims of the study are: a) to complete development of a package of literacy-adapted diabetes and CVD patient education materials by developing two video/DVDs addressing self-management recommendations appropriate to the needs, resources, and environment of the population; b) to randomize urban African-American adults with type 2 diabetes and a high CVD risk profile into one of four study arms: Usual Care (Arm 1), Literacy-Adapted Education and Problem-Solving Training Self-Study (Arm 2), Literacy-Adapted Education and Group Problem-Solving Training (Arm 3), and Literacy-Adapted Education and Individual Problem-Solving Training (Arm 4); c) to conduct baseline, 3-month post-intervention, and 6-month post-intervention assessment visits to analyze and compare effectiveness of the literacy-adapted education and problem-solving interventions, as compared to Usual Care, in improving the skills of knowledge, problem-solving and health literacy, behaviors of patient activation and diabetes self-management, and clinical outcomes of A1C, blood pressure and lipids; and d) to perform a cost-effectiveness analysis of each intervention arm as compared to Usual Care. If proven effective, this research will yield low literacy diabetes and CVD patient education and self-management intervention tools for dissemination to high-risk urban minority populations. Moreover, the cost-effectiveness analysis will provide evidence to support decision-making regarding implementation of the models to achieve cardiovascular disease patient self-management goals in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CarePacket of standard print patient education materials on CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA). |
| Self Study | Experimental | Behavioral: Education + Problem-Solving Training Self-StudyOne 90-minute educational session. Print materials and DVDs for self-study |
| Group Problem-Solving Training | Experimental | Behavioral: Education + Group Problem-Solving TrainingOne 90-minute education session. Group problem-solving training (eight, 90-minute sessions) |
| Individual Problem-Solving Training | Experimental | Behavioral: Education + Individual Problem-Solving TrainingOne 90-minute education session. Individual problem-solving training (eight, 60-minute sessions) |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 25 years or older
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Education + Problem-Solving Training Self-StudyAlso: Self-Management Training Self-Study, Project DECIDE Self-Study* 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. | Behavioural | Self Study |
| Education + Group Problem-Solving TrainingAlso: Group Self-Management Training, Project DECIDE Group Training* Education + Group Problem-Solving Training * One session of the Literacy-Adapted Diabetes and CVD Risk Education * Group problem-solving training eight, 90-minute sessions | Behavioural | Group Problem-Solving Training |
| Education + Individual Problem-Solving TrainingAlso: Individual Self-Management Training, Project DECIDE Individual Training* Education + Individual Problem-Solving Training * One session of the Literacy-Adapted Diabetes and CVD Risk Education * Individual problem-solving training (eight, 60-minute sessions) | Behavioural | Individual Problem-Solving Training |
| Usual CareAlso: Standard Print Education Materials, Project DECIDE Usual Care* 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. | Behavioural | Usual Care |
Primary outcome
HbA1C
Time frame: Screening, 3 months post intervention, 6 months post-intervention
8 secondary outcomes
Blood pressure
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Lipid Panel
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Health Problem Solving Scale
Time frame: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Diabetes and CVD Knowledge Test
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Patient Activation Measure
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention
Summary of Diabetes Self-Care Activities Scale
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention
Barriers to Self-Management
Time frame: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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 12 May 2015.
- 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.
- Background: PubMed 12763713Hill-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.
- 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.
- Background: PubMed 23042504Majid 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.
- Background: PubMed 22354210Hill-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.
- Background: PubMed 23312614Fitzpatrick 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.
- Derived from this study: PubMed 27879359Fitzpatrick 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.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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, ABPP principal investigator
Johns Hopkins School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education + Problem-Solving Training Self-Study, Education + Group Problem-Solving Training and Education + Individual Problem-Solving Training in people with Type 2 Diabetes, run by Johns Hopkins University at 3 sites 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 5 inclusion and 5 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
HbA1C (time frame: Screening, 3 months post intervention, 6 months post-intervention). 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 NCT00964587, which also lists 9 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 12 May 2015.