Diabetes Mellitus, Type IINCT02988427
Measuring Patient Engagement in Diabetes Care
An observational study of Diabetes Mellitus, Type II, run by Northwestern University.
Trial summary
We will develop a new measure of patient engagement/activation specific to the context of diabetes self-care Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type II
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2016
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients ages 21 and older will be recruited from study clinics
Who may be able to join
- Patient is age 21 and older
- Patient is English speaking
- Patient has been diagnosed with Type II Diabetes by a health care provider
Who cannot join
- Severe, uncorrectable vision
- Hearing impairments
- Cognitive impairment
About this study
We will develop a new measure of patient engagement/activation specific to the context of diabetes self-care
- Conditions
- Diabetes Mellitus, Type II
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-efficacy
Self-efficacy will be assessed using an 8-item measure developed by Sarkar and colleagues asking respondents to rate their confidence in their ability to perform individual diabetes self-care activities, such as monitoring their blood glucose, getting medical attention, and taking care of their health.
Measured: Baseline
Secondary outcomes (3)
Diabetes Distress
The Diabetes Distress Scale (DDS) is a 17-item measure of diabetes-related emotional distress. It has four subscales corresponding to emotional burden, physician-related distress, regimen distress, and diabetes interpersonal distress.
Measured: Baseline
Functional Health Status
Patient-Reported Outcomes Measurement Information System (PROMIS) is a national resource providing state-of-the-art tools for assessing patient symptoms and health outcomes. Short form measures of physical health (function) and emotional health (depression, anxiety) will be collected.
Measured: Baseline
Clinical Outcomes
Hemoglobin A1c (HbA1c) and LDL cholesterol lab values, along with systolic and diastolic blood pressure values are collected as part of routine clinical care at every 3 months, and will be recorded from the medical record from the most recent visit.
Measured: 3 months before baseline to 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Michael Wolf, PhD, MPH, MA, Principal investigator, Northwestern UniversityStacy Bailey, PhD, MPH, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988427
- Sponsor's protocol ID
- STU00203715
- Status last verified
- Mar 2017
- First submitted
- 7 Dec 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Patient Engagement in Diabetes Care
- ClinicalTrials.gov ID
- NCT02988427
- Acronym / sponsor ID
- STU00203715
- Conditions
- Diabetes Mellitus, Type II
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Dec 2016 (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.
We will develop a new measure of patient engagement/activation specific to the context of diabetes self-care
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients ages 21 and older will be recruited from study clinics
Key inclusion criteria (3 listed)
- Patient is age 21 and older
- Patient is English speaking
- Patient has been diagnosed with Type II Diabetes by a health care provider
Key exclusion criteria (3 listed)
- Severe, uncorrectable vision
- Hearing impairments
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes Self-efficacy
Time frame: Baseline
Self-efficacy will be assessed using an 8-item measure developed by Sarkar and colleagues asking respondents to rate their confidence in their ability to perform individual diabetes self-care activities, such as monitoring their blood glucose, getting medical attention, and taking care of their health.
3 secondary outcomes
Diabetes Distress
Time frame: Baseline
Functional Health Status
Time frame: Baseline
Clinical Outcomes
Time frame: 3 months before baseline to 3 months after baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Michael Wolf, PhD, MPH, MA principal investigator
Northwestern University
Stacy Bailey, PhD, MPH principal investigator
University of North Carolina
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type II, run by Northwestern University.
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: withdrawn, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Diabetes Self-efficacy (time frame: Baseline). 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 15 Mar 2017.