Measure | Method |
---|---|
Primary outcomes | |
Hemoglobin A1C | Blood specimens will be obtained at baseline and at 3, 6, 9, and 12 months. |
Blood pressure | Blood pressure readings will be obtained by study nurses using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-min intervals and give an average of the 3 BP readings. |
LDL - cholesterol | Blood specimens will be obtained at baseline and at 3, 6, 9, and 12 months. |
Secondary outcomes | |
Behavioral skills (SDSCA) | This will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale [47], a brief, validated self-report questionnaire of diabetes self-care. |
Medication adherence | This will be measured with the 6-item validated self-report Brooks Medication Adherence Scale (BMAS) [48]. |
Resource utilization/cost | Previously validated questions that capture information on hospitalizations, physician visits, professional visits, and medications will be used. |
Quality of life (SF-12) | The SF-12 [49] is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores. |
Quality adjusted life years (EQ-5D) | The EQ-5D is a validated measure to assess health status developed by the EuroQol group and assess health status across 5 dimensions using 26 items [50]. |
Social determinants | |
Financial resources | Financial resources will be measured using 7 items previously validated by Behavioral Risk Factor Surveillance System [51] regarding the social context in which a respondent lives. |
Housing insecurity | Housing insecurity will be based on a series of 6 questions developed by Columbia University to measure the full spectrum of instability in housing over one year [52]. |
Food insecurity | 6-item scale classifies household food security status and is valid for households with and without children [53] |
Perceived stress | The perceived stress scale (PSS) is a 4-item scale that assesses the degree to which the respondent finds situations stressful [54]. |
Coping | Coping will be assessed using the 8-item emotional approach coping measure to allow evaluation of emotional processing and emotional expression [55]. |
Perceived discrimination | Previously validated items from the DISTANCE survey [56] will be used to capture perceived discrimination. |
Adverse childhood experiences | The Adverse Childhood Experiences scale is a 10-item scale that assesses the degree to which the respondent experienced childhood maltreatment [57]. |
Competing needs | This will be assessed by validated questions that capture the impact of competing subsistence needs on healthcare [58]. |
Covariates | |
Patient demographics | Previously validated items from the National Health Interview Survey will be used to capture demographic characteristics. |
Social support | The Medical Outcomes Study (MOS) Social Support Survey [59] will be used to measure social support. |
Health literacy | A 3-item literacy scale noting capacity to obtain, process, and understand basic health-related decisions will measure health literacy [60]. |
Depression (Patient Health Questionnaire – 9 – PHQ-9) | This will be assessed by the validated 9-item PHQ-9 [61]. |
Medical comorbidity (chronic health conditions—BRFSS) | This will be assessed using previously validated items from the Behavioral Risk Factor Surveillance System [62]. |