Table 1.
Schedule of Evaluations
| Study Measure | Method | Baseline | Study Visits | Endline | Interim Visits1 |
|---|---|---|---|---|---|
|
| |||||
| 0 mo | 6, 12, 18 mo | 24 mo | as needed | ||
| Demographics | Q | X | |||
| Depressive symptoms | |||||
| PHQ-9 | Q | X | X | X | X |
| SCL-20 | Q | X | X | X | |
| Other psychiatric conditions | |||||
| MoCA; AUDIT-10; DAST-10; | Q | X | X | ||
| GAD-7; Bipolar disease/Psychosis | Q | X | X | X | |
| Medical history | |||||
| Patient history | Q | X | |||
| Family history | Q | X | |||
| Medication use | Q | X | X | X | X |
| Medical complications | Q | X | X | X | X |
| Risk factor control | |||||
| SBP/DBP, HR | E | X | X | X | X |
| FBG | L | X | X | X | X |
| HbA1c | L | X | X | X | X |
| Lipids (TC, HDL, LDL, TG) | L | X | X | X | X |
| Lifestyle habits: PA, alcohol and tobacco use | Q | X | X | X | X |
| Anthropometry: height, weight, BMI, WC | E | X | X | X | X |
| Clinical examinations: | |||||
| Physical, eye, and foot inspections | E | X | X | X | X |
| Electrocardiogram | E | X | X | X | X |
| Microalbuminuria (UACR) | L | X | X | ||
| Serum creatinine, Na+; K+; ALT | L | X | X | X | |
| Patient self-efficacy: SDSCA | Q | X | X | X | |
| Quality of life, health utility, satisfaction | |||||
| HUI-3 | Q | X | X | ||
| DTSQ | Q | X | X | ||
| Costs of care: direct, indirect | Q, R | X | X | ||
| SAEs/AEs | Q | X | X | X | |
Abbreviations: PHQ-9, Patient Health Questionnaire-9; SCL-20, Symptom Checklist-20; MoCA, Montreal Cognitive Assessment; AUDIT-10, Alcohol Use Identification Test-10; DAST-10, Drug Abuse Screening Test-10; GAD-7, Generalized Anxiety Disorder-7; SBP, Systolic Blood Pressure; DBP, Diastolic Blood Pressure; HR, Heart Rate; FBG, Fasting Blood Glucose; HbA1C, Hemoglobin A1C; TC, Total Cholesterol; HDL, High Density Lipoprotein; LDL, Low Density Lipoprotein; TG, Triglycerides; BMI, Body Mass Index; WC, waist circumference; UACR, Urine Albumin Creatinine Ratio; Na+, Sodium; K+, Potassium; ALT, Alanine Aminotransferase; HUI-3, Health Utilities Index-3; DTSQ, Diabetes Treatment Satisfaction Questionnaire; SDSCA, Summary of Diabetes Self-Care Activities; SAEs, Severe Adverse Events; AEs, Adverse Events; Q, Questionnaire; E, Examination; L, Laboratory test; R, Records.
Interim visits measures are collected from participants in the intervention arm, as needed, at the discretion of the care coordinator. Incidence of medical complications and severe and adverse events were asked at each interim visit.