Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.
The goal of this study is to assess the feasibility and efficacy of usual care with the QBSafe intervention compared to usual care alone within a cluster randomized clinical trial among patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
154
an intervention comprised of (a) a set of conversation cards (QBSafe ASK) designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns.
Fair Haven Community Health Center
New Haven, Connecticut, United States
Illness Intrusiveness Measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6
The change in illness intrusiveness measured by the validated Illness Intrusiveness Ratings Scale (IIRS). IIRS is comprised of 13 items that ask participants to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Overall score is calculated by summing the 13 items creating a value between 13 to 91, where higher scores indicate increased illness intrusiveness. Analysis will assess the 6 months response as the outcome adjusting for arm and the initial score. Subscales are scored 1-7 with higher scores indicating more disruption or intrusiveness.
Time frame: Month 6
HbA1c at Month 6
HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.
Time frame: Month 6
Diabetes Distress Will be Measured Using the Diabetes Distress Scale (DDS-17) at Month 6
The DDS is a validated 17-item self-report instrument where each item is rated on a 6-point Likert scale from (0) "not a problem" to (6) "a serious problem." The scale yields a total DDS score, plus scores for 4 subscales: emotional burden, regimen distress, physician distress, and interpersonal distress. Total and subscale scores are calculated using mean item scores, which are then categorized as little or no distress (0- 2.0), moderate distress (greater than or equal to 2.0 and less than or equal to 2.9) and high distress (3.0-6.0). Moderate and high distress are considered 'clinically significant.'
Time frame: Month 6
Treatment Burden Will be Assessed Using the Treatment Burden Questionnaire (TBQ) at Month 6
The TBQ is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It is composed of 15 items rated on a Likert scale ranging from 0 (no impact) to 10 (considerable impact) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 0 to 150. Higher scores reflect higher treatment burden.
Time frame: Month 6
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