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Table 2 Instruments used for self-reported outcomes measures

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

Instruments Outcome measurements
Outcomes measured on patients
 EQ-5D-5L [59] Generic HRQoL questionnaire. The self-reported description assesses five domains: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression
 ADDQoL-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 drink
 DDS2, 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 regimen
 STAI-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 intensity
 BDI-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 others
 DES-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 scale
 IPAQ, 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 activities
 MEDAS, 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 achieved
 MMAS, Morisky Medication Adherence Scale [67] This questionnaire assesses the medication adherence, including a four-item self-report measure with an established concurrent and predictive validity
 INDICA-SATP Patient 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 project
 Diatek It is a specific instrument created in the context of this project, to assess potential changes in patient knowledge about DM based on the CPG INDICA
 INDICA-LSQ It 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 nurses
 LATCon, 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-taking
 INDICA-KNOW Knowledge change among healthcare professionals will be measured with the aid of an instrument with 20 questions based on the contents of the INDICA CPG
 INDICA-SATC Acceptability 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]
  1. DST: decision support tool.