Type 2 DiabetesNCT02497170
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
A study testing Education of goal setting and achievement in people with Type 2 Diabetes, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Education of goal setting and achievement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
- Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
- Patients who give written consent to participate
Who cannot join
- Patients below age 18, children are not treated in the facility for type 2 diabetes
- Patients who attend less than 4 monthly appointments for diabetes,
- Patients who do no give written consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes
Read the detailed description
The Primary Investigator will meet with patients that attend routine visits for Diabetes 2 in the primary care office on a monthly basis to set behavior goals. Behavior goals will be set by patient's choice of 4 out of 7 of the AADE7 recommendations. The goals are health eating, being active, monitoring,taking medications, problem solving, healthy coping, and reducing risk. Once the goal is chosen, the PI and patient will make a plan to address the goals on a monthly basis for four months. There will be pre and post questionnaires that will evaluate diabetes knowledge and self-efficacy. There will also be a pre and post measure of the patient's Hemoglobin A1c which is a measurement that helps determine the extent of glycemic control over a three-month period.
The goal of the study is to determine if translation of the AADE7 behavioral goals into the primary care setting will make a difference in diabetes knowledge, self efficacy, and Hemoglobin A1c.
- Conditions
- Type 2 Diabetes
- Being tested
- Education of goal setting and achievement
- 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 of goal setting and achievementBehavioural
Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them
| Study group | Role | What they receive |
|---|---|---|
| Life style changes | Other | Pre and post after education intervention Education program Receives: Behavioral: Education of goal setting and achievement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Pre and Post Differences
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- melissa souza, Principal investigator, Rutgers University Newark New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497170
- Sponsor's protocol ID
- PRO201500001877
- Status last verified
- Mar 2016
- First submitted
- 10 Jul 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02497170
- Acronym / sponsor ID
- PRO201500001877
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Jul 2015 (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.
Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes
Detailed description
The Primary Investigator will meet with patients that attend routine visits for Diabetes 2 in the primary care office on a monthly basis to set behavior goals. Behavior goals will be set by patient's choice of 4 out of 7 of the AADE7 recommendations. The goals are health eating, being active, monitoring,taking medications, problem solving, healthy coping, and reducing risk. Once the goal is chosen, the PI and patient will make a plan to address the goals on a monthly basis for four months. There will be pre and post questionnaires that will evaluate diabetes knowledge and self-efficacy. There will also be a pre and post measure of the patient's Hemoglobin A1c which is a measurement that helps determine the extent of glycemic control over a three-month period.
The goal of the study is to determine if translation of the AADE7 behavioral goals into the primary care setting will make a difference in diabetes knowledge, self efficacy, and Hemoglobin A1c.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Life style changes | Other | Behavioral: Education of goal setting and achievementPre and post after education intervention Education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
- Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
- Patients who give written consent to participate
Key exclusion criteria (3 listed)
- Patients below age 18, children are not treated in the facility for type 2 diabetes
- Patients who attend less than 4 monthly appointments for diabetes,
- Patients who do no give written consent to participate
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 of goal setting and achievementEducation of American Association of Diabetes Educations 7 behavioral goals and how to achieve them | Behavioural | Life style changes |
Primary outcome
Hemoglobin A1c
Time frame: 4 months
Pre and Post Differences
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 11 Mar 2016.
Related trials for Type 2 Diabetes
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
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.
melissa souza principal investigator
Rutgers University Newark New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education of goal setting and achievement in people with Type 2 Diabetes, run by Rutgers, The State University of New Jersey 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 3 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 11 Mar 2016. 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?
Hemoglobin A1c (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2016.