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Table 1 Outcome measurements according to periods of follow-up and type of collection

From: Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients—the INDICA study: a cluster randomized controlled trial

Time Outcome measurements
Outcomes measured on patients
M0, M3, M6, M12, M18, M24 (F to F) Demographic data, health history, history of DM, DM health status, current medications, risk factors for complications of poorly controlled DM
Laboratory measurements
M0, M12, M24 (CT) HbA1c; fasting glucose; total cholesterol; HDL, LDL, and non-HDL cholesterol; triglycerides; serum creatinine; albumin/creatinine ratio; and glomerular filtration rate
M3, M18 (CT) HbA1c, fasting glucose
M6 (CT) HbA1c, fasting glucose, total cholesterol, HDL, LDL cholesterol, and triglycerides
Anthropometric measurements
M0, M3, M6, M12, M18, M24 (F to F) BMI, waist/hip ratio, systolic and diastolic blood pressure, heart rate
Macro and microvascular complications
M0, M12, M24 (F to F, ECR) Incidence of new ischemic heart events, hospitalization for congestive heart failure, peripheral artery disease, carotid stenosis fulfilling criteria for endarterectomy or confirmed ischemic or hemorrhagic stroke, incidence or progression of diabetic retinopathy, incidence or progression of diabetic nephropathy
Eye examination
M3, M24 (CT) Retinography and macular examination by OCT
Instruments used for self-reported outcomes measures
M0, M12, M24 (SRI) ADDQoL-19, BDI-II, DES-SF, DDS2, DIATEK, IPAQ, MEDAS, STAI-S, INDICA-LSQ
(F to F) EQ-5D-5 L, MMAS
M6, M18 (SRI) ADDQoL-19, IPAQ, MEDAS
(F to F) EQ-5D-5 L, MMAS
Healthcare utilization
M0, M3, M6, M12, M18, M24 (F to F, ECR) Visits to primary care services, nurses, specialists; hospital admissions, emergency room visits, laboratory procedures, and other diagnostic tests; medication
Satisfaction
M24 (SRI) INDICA-SATP
Outcomes measured on physicians and nurses
M0 (F to F) Demographic data, years in practice, practice descriptors
M0, T3 (SRI) INDICA-KNOW, LATCon
M24 (SRI) INDICA-SATC
  1. BMI: body mass index; F to F: face to face interview; CT: clinical test; DM: diabetes mellitus; ECR: electronic clinical records; HDL: high-density lipoprotein; LDL: low-density lipoprotein; OCT: optical coherence tomography; SRI: self-reported interview.
  2. Note: see description of the questionnaires in Table 2.