Measuring Patient Engagement in Diabetes Care

Diabetes Mellitus, Type II Clinical Trial

Official title:

Measuring Patient Engagement in Diabetes Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02988427
• Other study ID #: STU00203715
• Status: Withdrawn
• Phase: N/A
• First received: December 7, 2016
• Last updated: March 13, 2017
• Start date: December 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We will develop a new measure of patient engagement/activation specific to the context of diabetes self-care

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Patient is age 21 and older

2. Patient is English speaking

3. Patient has been diagnosed with Type II Diabetes by a health care provider

Exclusion Criteria:

1. Severe, uncorrectable vision

2. Hearing impairments

3. Cognitive impairment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	University of North Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	3 months before baseline to 3 months after baseline