Measuring Patient Engagement in Diabetes Care

Withdrawn

• Conditions: Diabetes Mellitus, Type II

• Registration Number: NCT02988427
• Lead Sponsor: Northwestern University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

1. Severe, uncorrectable vision
2. Hearing impairments
3. Cognitive impairment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes Self-efficacy	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	3 months before baseline to 3 months after baseline	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.
Diabetes Distress	Baseline	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.
Functional Health Status	Baseline	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.