治験レーダー

Diabetes Distress

Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (=PAID-20). The Problem Areas In Diabetes questionnaire measures diabetes distress on a 5-point Likert scale ranging from 1 (Not a problem) to 5 (Serious Problem). A higher score represents higher diabetes distress.

Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).

Emotional well-being

Emotional well-being will be operationalised as the score on the 5-item World Health Organization Well-Being Index (=WHO-5). The score on the WHO-5 is measured on a 6-point scale ranging from 0 (At no time) to 5 (All of the time) with a lower score representing less emotional well-being.

Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

Psychological self-efficacy in relation to diabetes

Operationalised through the Short form of the Diabetes Empowerment Scale (=DES-SF). Psychological self-efficacy in relation to diabetes is assessed on a 5-point scale ranging from 0 (Strongly disagree) to 4 (Strongly agree), with higher scores representing higher psychological self-efficacy in relation to diabetes.

Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

Social Engagement

Social Engagement will be assessed through the 6-item Lubben Social Network Scale (LSNS-6). The Lubben Social Network Scale measures Social Engagement on a 6-point scale ranging from 0 (None) to 5 (Nine or more). A higher score represents higher social engagement.

Social Engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)

Fatigue

Fatigue will be assessed through the 8-item Fatigue subscale of the Checklist Individual Strength (=CIS-F). The Fatigue subscale of the Checklist Individual Strength consists of both positively and negatively framed items that are measured on a 7-point scale ranging from 1 (No, that is not true) to 7 (Yes, that is true). The positively framed items (e.g., I feel fit) will be reverse coded. A higher score will therefore represent stronger fatigue.

Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)

HbA1c

Participants will self-report various outcome measures typical for assesseing glycaemic control in type 1 diabetes. One of these measures is the self-reported Haemoglobine A1c (=HbA1c) value. HbA1c will be measured on different scales, depending on clinical norms of the participating country. This will either be in percentage or mmol/mol. There is no formal minimum or maximum value of HbA1c, although realistically values will be in between 5 and 12 when measured in percentage, or 30 and 100 when measured in mmol/mol. For both scales, a lower score represents better glycaemic control. For data analysis, all scores measured in percentage will be transformed to a HbA1c value measured in mmol/mol.

Glycaemic control measures, in this case Haemoglobine A1c, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)

Time in/above/below range

Participants will self-report various outcome measures typical for assesseing glycaemic control in type 1 diabetes. One of these measures is the self-reported time in/above/below range. Participants can indicate their own personal target range for blood glucose values, and then indicate the percentage of time during which they were in, above, and below this personal range across the past 14 days. A higher percentage for time in range represents better glycaemic control. A lower percentage for time above range and time below range represents worse glycaemic control.

Glycaemic control measures, in this case time in/above/below range, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)

Events of ketoacidosis/severe hypoglycaemia

Participants will self-report various outcome measures typical for assesseing glycaemic control in type 1 diabetes. One of these measures is the self-reported frequency of events of ketoacidosis and severe hypoglycaemia across the past 12 months when measured at baseline, and across the past 3 months when measured at the 3 and 6 months assessment, respectively. A higher self-reported frequency of events of ketoacidosis and/or severe hypoglycaemia represents worse glycaemic control.

Glycaemic control measures, in this case frequency of events of ketoacidosis and severe hypoglycaemia, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)