Measuring Patient Engagement in Diabetes Care

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02988427

Enrollment

Registered

2016-12-09

Start date

2016-12-31

Completion date

2016-12-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Outcome results