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05) after 4?months. The same applied, with nearly statistically significant differences, for autonomy outdoors (p=0.06) and social relationships (p=0.05). However, these effects disappeared at 12-month follow-up. As illustrated in table 4, we found no other statistically significant differences for the secondary outcome measures at 4 and 12?months. Table?4 Multilevel analyses for differences between intervention arm and control arm for secondary outcome measures at 4-month and 12-month follow-ups Discussion This study, with a low exposure of study participants to the complete intervention, could not demonstrate any effect of SMS on emotional, social or biomedical parameters, except for autonomy and participation with regard to activities indoors and the family role after 4?months. This effect in favour of the patients in the intervention arm had disappeared after 12?months. The critical issue of the implementation of SMS was the addition of a detection procedure as an inherent and integrated part of SMS. PNs were trained to identify eligible patients for the follow-up phase of SMS by applying screening questions during diabetes consultations. The DFT and DS were considered to be simple, patient-centred indicators of patients�� daily functioning and their selleck chemical emotional distress. The 4DSQ would enable the PNs and GPs to get more insight into the presence and severity of the emotional problems. For the effectiveness trial, a self-administered postal screening procedure was inserted into the study design to select patients from both the intervention and control arms similarly. To perform a pragmatic trial, we minimised the interference of the researchers in clinical practice as much as possible. The outcomes of DFT and DS on the research-driven screening were consistent with our assumptions based on the literature that approximately 20% of the diabetic population would be eligible for the follow-up phase of SMS. However, these efforts to select patients with emotional problems, aimed at increasing the contrast between patients in the intervention and control arms, appeared to be useless as the added detection method in routine practice did not function as expected. This was not a problem of PNs�� adherence to the SMS protocol, as the screening tools were integrated into diabetes consultations of more than 85% of the study participants. The problem was that the majority of study participants who scored above the cut-off values on the postal questionnaires did not meet the required detection criteria when screened face to face by the PNs. These patients were therefore not exposed to the follow-up phase of SMS.