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Table 1 Primary and secondary outcomes of the study

From: Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial

Variable

Description

Primary outcome

 Mental distress measured by the SRQ-20 questionnaire

Depression, anxiety, and other common mental health disorder symptoms will be assessed using the total score on the Brazilian version of the Self Reporting Questionnaire 20 (SRQ-20). The outcome will be presented as a total score ranging from 0 to 20 points, with higher scores indicating greater mental distress

Secondary outcomes

 Quality of Life assessed using the SF-36 questionnaire

Total score on the Brazilian version of the 36-Item Short Form Health Survey (SF-36) Questionnaire. It evaluates the quality of life across eight domains: Functional Capacity, Limitation due to physical aspects, Pain, General health status, Vitality, Social aspects, Emotional aspects, and Mental health. The outcome will be presented as a total score ranging from 0 to 100, with higher scores indicating lower quality of life

 Adherence to diabetes self-care behaviors assessed using the SCI-R questionnaire

Brazilian version of the Self-Care Inventory Revised (SCI-R) questionnaire, which reflects the follow-up of treatment recommendations and lifestyle habits related to diabetes care in the 2 months prior to the application. The outcome will be presented as a total score ranging from 11 to 55 points, with higher scores indicating a higher level of care

 Perception of stress assessed using the PSS questionnaire

Total score on the Brazilian version of the Perceived Stress Scale (PSS) questionnaire. The outcome will be presented as a total score ranging from 0 to 56 points, with higher scores indicating a greater level of stress

 Blood pressure

Systolic and diastolic blood pressure will be assessed using an appropriate sphygmomanometer according to the circumference of the arm. Three measures will be made for each subject and the mean of the three repeated measures will be considered

 Glycemic control

Glycated hemoglobin (HbA1c) dosage performed using high-performance liquid chromatography will be considered for glycemic control evaluation

 Lipid profile

Total cholesterol, HDL-c, LDL-c and triglycerides dosage