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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


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


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


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


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


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


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.