Measuring Patient Engagement in Diabetes Care

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type II

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients ages 21 and older will be recruited from study clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of North Carolina
• Investigators: Principal Investigator: Michael Wolf, PhD, MPH, MA, Northwestern University; Principal Investigator: Stacy Bailey, PhD, MPH, University of North Carolina

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STU00203715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No