Diabetes, Type2Diabetes
Conditions
Keywords
A1c, HbA1c
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALQBSafe
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.
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a cluster randomized clinical trial of usual care with a behavioral intervention (use of conversation cards during routine clinical encounters) compared with usual care alone. The study will randomize 10-15 clinicians and 72 of their patients with type 2 diabetes to each arm. Data collected includes medical record data, patient and clinician surveys, and audio-visual recordings of clinical encounters.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinicians * any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them Participants * diagnosed with DM2 * able to sign informed consent * fluent in either English or Spanish * HbA1c \>8%
Exclusion criteria
* Participants for whom an HbA1c target \>8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Illness Intrusiveness Measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6 | 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. |
| HbA1c at Month 6 | Month 6 | HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Will be Measured Using the Diabetes Distress Scale (DDS-17) at Month 6 | 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.' |
| Treatment Burden Will be Assessed Using the Treatment Burden Questionnaire (TBQ) at Month 6 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKasia Lipska, MD MHS
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 11.8 |
| BMI categories 18.5 to 24.9 (Healthy weight) | 8 Participants |
| BMI categories 25 to 29.9 (Overweight) | 45 Participants |
| BMI categories 30.0 to 39.9 (Obese) | 36 Participants |
| BMI categories 40.0+ (Class 3 Obseity) | 4 Participants |
| Body Mass Index (BMI) | 30.9 kg/m^2 STANDARD_DEVIATION 5.63 |
| Clinicians' Credentials Nurse Practitioner | 3 Participants |
| Clinicians' Credentials Physician (MD, DO) | 8 Participants |
| Comorbidities Cardiovascular disease | 12 Participants |
| Comorbidities Cerebrovascular disease | 8 Participants |
| Comorbidities Hyperlipidemia | 55 Participants |
| Comorbidities Hypothyroidism | 5 Participants |
| Confidence in Filling Out Medical Forms Missing | 0 Participants |
| Confidence in Filling Out Medical Forms Not at all/A little bit confident | 15 Participants |
| Confidence in Filling Out Medical Forms Quite a bit/Extremely confident | 111 Participants |
| Confidence in Filling Out Medical Forms Somewhat confident | 7 Participants |
| DDS subscale: Emotional Burden | 2.7 score on a scale STANDARD_DEVIATION 1.5 |
| DDS subscale: Interpersonal Distress | 2.0 score on a scale STANDARD_DEVIATION 1.44 |
| DDS subscale: Physician-related Distress | 1.6 score on a scale STANDARD_DEVIATION 0.75 |
| DDS subscale: Regimen-related Distress | 3.0 score on a scale STANDARD_DEVIATION 1.54 |
| Diabetes Complications Nephropathy | 13 Participants |
| Diabetes Complications Neuropathy | 19 Participants |
| Diabetes Complications Retinopathy | 18 Participants |
| Diabetes Distress Scale (DDS)- Overall | 2.2 score on a scale STANDARD_DEVIATION 1.02 |
| Diabetes Medications DPP-4 inhibitors | 20 Participants |
| Diabetes Medications GLP-1 | 49 Participants |
| Diabetes Medications Insulin | 43 Participants |
| Diabetes Medications Meglitinides | 0 Participants |
| Diabetes Medications Metformin | 59 Participants |
| Diabetes Medications SGLT-2 Inhibitors | 36 Participants |
| Diabetes Medications Sulfonylureas | 35 Participants |
| Diabetes Medications Thiazolidinediones (TZDs) | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Federal Poverty Level 0-150% | 61 Participants |
| Federal Poverty Level >150% | 5 Participants |
| Federal Poverty Level Missing | 8 Participants |
| HbA1c | 9.9 percent STANDARD_DEVIATION 1.7 |
| HbA1c categories 10.0+ | 29 Participants |
| HbA1c categories 8.0 to <9.0 | 28 Participants |
| HbA1c categories 9.0 to < 10.0 | 16 Participants |
| IIRS subscale: Instrumental | 3.1 score on a scale STANDARD_DEVIATION 1.56 |
| IIRS subscale: Intimacy | 2.7 score on a scale STANDARD_DEVIATION 2.15 |
| IIRS subscale: Relationship and personal | 2.2 score on a scale STANDARD_DEVIATION 1.58 |
| Illness Intrusiveness Ratings Score (IIRS)- Overall | 36.6 score on a scale STANDARD_DEVIATION 17.52 |
| Language Need Interpreter Support | 6 Participants |
| Language Spanish Speaking | 3 Participants |
| Mean Count Diabetes Medications | 2.8 medications STANDARD_DEVIATION 1 |
| Medical Insurance Commercial | 11 Participants |
| Medical Insurance Medicaid | 26 Participants |
| Medical Insurance Medicare | 22 Participants |
| Medical Insurance Self-Pay/Uninsured | 20 Participants |
| Percent of Days Covered | 69 percent days STANDARD_DEVIATION 29.8 |
| Primary Language English | 34 Participants |
| Primary Language Spanish | 40 Participants |
| Quality of life (QOL) | 6.2 score on a scale STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 154 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 31 Participants |
| Treatment Burden Questionnaire | 45.6 score on a scale STANDARD_DEVIATION 38.26 |
| Was an interpreter present during study visit? No | 53 Participants |
| Was an interpreter present during study visit? Yes, in person | 2 Participants |
| Was an interpreter present during study visit? Yes, on the phone | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 69 | 2 / 74 |
| other Total, other adverse events | 0 / 69 | 0 / 74 |
| serious Total, serious adverse events | 0 / 69 | 0 / 74 |
Outcome results
None listed