Discussion
T2D, anger, microvascular complications, diabetes complications, diabetes
DISEASE, RECRUITMENT, DIABETES
We found no effect on the patient activation measure in the population investigated. Nevertheless, patients emphasized that the intervention brought about a greater understanding of health challenges. They had started a process to improve health behaviors because the intervention had opened their eyes to new reflections and a greater awareness of their ways of living. Thus, the differences we observed in HbA1c, body weight and waist circumference in favor of the intervention group were further illuminated by the qualitative data. The findings made clear that the participants needed to find their own way and time to take on actions.The results indicate that the participants in this rather healthy T2D population perceived that they could manage their daily life with the condition. Biomarkers as well as findings from the interviews showed that the patients did not express that they had severe symptoms or high burden of managing their health care. Thus, it is not unexpectedly that the PRO scales demonstrated a profound ceiling effect. Overall, participants reported relatively high patient activation scores at baseline and follow-up. The results indicate that the participants perceived that they could handle information to help them to better self-manage their health. This finding indicates that using primarily generic instruments in our population might not be sensitive enough to capture change in perception of health and well-being. Previous studies suggesting that self-report scales lack discriminative ability for more healthy populations indicates that they must be used with caution among people with diabetes displaying scores close to the normal population [However, some participants expressed frustration about having diabetes in the qualitative part of the study. To be allowed to share such thoughts and anger in consultations might be essential for self-care activities. Undoubtedly, self-management support that helps people to accept the disease is important to enable patients’ confidence in making treatment choices and taking care of their diabetes [Although small, the mean difference in glycemic control in favor of the intervention group is a positive finding. There is significant evidence that smaller HbA1c improvements are likely to reduce the risk of diabetes complications [In terms of meeting clinical diabetes guidelines, it has previously been reported that there are major gaps in the performance of recommended screening procedures to detect microvascular complications in Norwegian primary care practices [Our findings show that the intervention could have a meaningful impact when starting a change process. However, achieving and sustaining long-term changes in health behavior requires continuous education, behavioral and psychosocial support [There are several limitations to this study. Our sample size was small, primarily due to the recruitment challenges. The pandemic also made it difficult for the participants to engage in physical activity as fitness centers were closed, and people were not allowed to meet face-to-face. Thus, both physical and social incentives to keep on track faded out. It might be a limitation that we did not collect data from qualitative interviews with participants in the control group as such data might have shed light on everyday life during the pandemic also for this group. Furthermore, we primarily used generic PROs, which demonstrated methodological problems due to ceiling effects and lack of sensitivity. Likewise, mean HbA1c and findings from the interviews showed that the study sample consisted of adults with relatively well-regulated T2D with less potential to change health outcomes. Therefore, these outcome measures had limited potential for improvement. Finally, patients invited to the study were recruited from scheduled consultations which could indicate that they did not have explicit health problems and little motivation to engage in healthier behaviors and undertake new habits and activities. Although the inclusion of all persons in the waiting room area indicates that our results are representative for the general population attending a GP appointment, we did not have more detailed information on additional diagnosis or underlying conditions for these patients. Although underpowered to detect differences in scale scores, the RCT design was a strength. Furthermore, few participants dropped out of the study from either group. Only, two, three and two participants did not meet at the 3-, 6- and 12-months visits, respectively (