Background
Methods
Trial design
Subjects
Patient inclusion criteria
Patient exclusion criteria
Primary care professionals
Setting and recruitment
Random assignment
Blinding
Interventions
Patient interventions
Interventions for primary care physicians and nurses
Ethics
Endpoints
Primary endpoint
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 |
Secondary endpoints
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Cardiovascular risk factors: mean change of BMI, waist circumference, and waist-to-hip ratio, systolic and diastolic blood pressure, total cholesterol and its fractions (low-density lipoprotein (LDL), high-density lipoprotein (HDL), and nonHDL), and triglycerides. Blood pressure is measured twice in one arm (right when possible) in a sitting position, with a digital sphygmomanometer trademark OMRON© model M6, and the average of the two readings will be recorded. Smoking status is determined by self-report of whether the subject currently smoked.
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Macrovascular diabetes complications: new ischemic heart events (angor pectoris, myocardial infarction, surgical or percutaneous coronary revascularization), hospitalization for congestive heart failure, peripheral artery disease (surgical or percutaneous peripheral arterial revascularization, nontraumatic lower limb amputation), carotid stenosis fulfilling criteria for endarterectomy, or confirmed ischemic or hemorrhagic stroke. The annual occurrence of cardiovascular events, surgical procedures, or hospitalization is verified by reviewing the medical records.
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Microvascular diabetes complications: Incidence and progression of diabetic nephropathy: mean change in UACR, UACR ≥ 30 mg/g, mean change in estimated glomerular filtration rate (eGFR), eGFR < 60 mL/min/1.73 m2 and need for renal replacement therapy (dialysis or renal transplantation). Incidence and progression of diabetic retinopathy, according to the results of a retinography, and incidence and progression of diabetic macular edema, according to the results of an optical coherence tomography (OCT) and a retinography, are measured at months 3 and 24 of the study. Incidence of diabetic polyneuropathy is measured using the Michigan Neuropathy Screening Instrument (MNSI), an emergent instrument used to assess distal diabetic peripheral polyneuropathy. Only the 15-item self-administered MNSI, which is scored by adding up abnormal responses [41] will be applied. MNSI was translated into and back-translated from Spanish for its use in the INDICA study.
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Health-related quality of life (HRQoL), distress, anxiety, depression, satisfaction with the interventions, health behaviors, and changes in knowledge about diabetes self-management: all instruments selected to measure these outcomes are reported in Table 2.Table 2Instruments used for self-reported outcomes measuresInstrumentsOutcome measurementsOutcomes measured on patientsEQ-5D-5L [59]Generic HRQoL questionnaire. The self-reported description assesses five domains: mobility, self-care, usual activity, pain/discomfort, and anxiety/depressionADDQoL-19, Audit of Diabetes-Dependent Quality of life [60]Specific HRQoL questionnaire for DM. It assesses 19 domains: leisure activities, working life, travel, holiday, physical activities, family life, social life, personal life, sex life, physical appearance, self-confidence, motivation, reaction from others, feelings about the future, financial situation, living conditions, reliance on others, freedom to eat, and freedom to drinkDDS2, Diabetes Distress Scale [61]It is a validated two-item diabetes distress-screening instrument that asks respondents to rate on a six-point scale the degree of distress caused by the two following items: (1) feeling overwhelmed by the demands of living with diabetes and (2) feeling that I am often failing with my diabetes regimenSTAI-S, State Trait Anxiety Inventory [62]It is a self-description questionnaire including two non-dependent scales, the applied state-anxiety scale (STAI State) and the trait-anxiety scale (STAI Trait). It assesses transient emotional state or condition as characterized by subjective feelings of tension and apprehension that can fluctuate in time and intensityBDI-II, the Beck Depression Inventory II [63]It is a validated 21-item self-report inventory that measures depressive symptoms such as sadness, pessimism, suicidal thoughts or wishes, tiredness or fatigue, loss of energy, and loss of pleasure, among othersDES-SF, Diabetes Empowerment Scale-Short Form [64]This questionnaire assesses patient empowerment on T2DM management, including eight items with responses on a five-point Likert scaleIPAQ, International Physical Activity Questionnaire. [65]This questionnaire checks physical activity and provides information on the time spent on walking, moderate-intensity activities, and vigorous and sedentary activitiesMEDAS, Mediterranean Diet Adherence Screener [66]This questionnaire assesses diet recommendation adherence. It consists of 14 targets for food consumption rated with one point for each target achievedMMAS, Morisky Medication Adherence Scale [67]This questionnaire assesses the medication adherence, including a four-item self-report measure with an established concurrent and predictive validityINDICA-SATPPatient satisfaction and usability of the web portal and the mobile phone communication system are assessed with a specific instrument created in the context of this projectDiatekIt is a specific instrument created in the context of this project, to assess potential changes in patient knowledge about DM based on the CPG INDICAINDICA-LSQIt is a specific instrument created in the context of this project used to assess attitudinal changes of patients regarding lifestyles, based in the Transtheoretic Model of Behavior Change [68]Outcomes measured on physicians and nursesLATCon, Leeds Attitude toward Concordance scale [69]It is a 12-item self-reported scale to assess patients’ and health professionals’ attitudes toward concordance in medicine-takingINDICA-KNOWKnowledge change among healthcare professionals will be measured with the aid of an instrument with 20 questions based on the contents of the INDICA CPGINDICA-SATCAcceptability and usability of the DST and the feedback screen is measured according to four different dimensions: acceptability of interactions and time devoted using the software communication technology, impact on patients, impact on the clinician’s practice, and communications issues such as quality of feedback and formats used [70]
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Attitude toward concordance and knowledge about the clinical management of diabetes: these instruments, reported in Table 2, are used to evaluate the interventions on physicians and nurses included in groups 2 and 3.