임상시험 레이더

Hemoglobin A1C (glycated hemoglobin) level

Hemoglobin A1C (glycated hemoglobin) is a routinely used laboratory measure that reflects average blood glucose levels over the preceding 3 months. In this study, A1C values will be obtained from participants' electronic medical records (EMR) as part of routine clinical care; no additional blood draws will be required for research purposes. Baseline A1C will be defined as the most recent value within ±4 weeks of enrolment. Follow-up A1C will be the value obtained closest to 6 months after enrolment, within routine clinical testing intervals. A1C is reported as a percentage (%), with higher values indicating poorer glycemic control. Change in A1C from baseline to 6 months will be used to assess the effect of the intervention on glycemic control. The secondary analysis will adjust for baseline A1C and relevant clinical factors, including medication changes where applicable.

6 months

The University of California, Los Angeles (UCLA - 3) score

The UCLA 3-item Loneliness Scale (UCLA-3) is a validated, brief self-reported measure used to assess subjective feelings of loneliness and social isolation. It consists of three questions that ask participants how often they experience key aspects of loneliness: (1) lacking companionship, (2) feeling left out, and (3) feeling isolated from others. Each item is scored on a 3-point Likert scale: 1. = Hardly ever 2. = Some of the time 3. = Often The total score ranges from 3 to 9, with higher scores indicating greater perceived loneliness. In this study, the UCLA-3 is administered at baseline and at 6 months electronically via REDCap. A score of ≥5 is used as the threshold to define clinically relevant loneliness for study eligibility. Change in UCLA-3 score over time is used to assess the effect of the intervention, with a reduction in score indicating improvement in perceived loneliness.

6 months