Quality of life is a major treatment goal for patients with psychiatric disorders [7, 11, 23]. A low-threshold telemedical care program containing regular telephone calls and SMS-messages was able to improve quality of life compared to a control group in almost all aspects. These findings are in line with another study that also investigated a mobile health (mHealth) approach. Ben-Zeev (et. al) compared the mHealth intervention FOCUS with a widely used group self-management intervention called WRAP [24]. As one of the secondary outcomes quality of life was investigated. The FOCUS participants showed significant improvements between baseline and the six months follow up. Even though the FOCUS intervention substantially differs slightly from Tecla, the mode of administration via information and communication technologies is similar. The general feasibility, acceptance and efficiency of electronic Health (eHealth) and mHealth interventions for people with serious mental illnesses is proven by several other studies [25–27].
However, the WHOQOL was proven as an adequate tool for assessing quality of life in different cultures and population groups [28, 29]. Therefore, in this study we have adopted a generic tool [6], that can be broadly applied for assessing quality of life in different cultures and population groups [30, 31]. The WHOQOL-BREF is less affected by disease-related factors [17] and has been applied in patients with schizophrenia with good reliability and validity [31, 32], even in psychotic stages, on medication and in patients with relatively low education level [7]. Kim et al. compared patients’ assessments of their own quality of life with WHOQOL-BREF with assessments of proxies (such as family members, caregivers) and found a moderate to good accordance between both assessments of the patients’ quality of life [8].
Even though schizophrenia and bipolar disorder are different diseases, there are similarities between them like the extent of quality of life. Both diseases showed similar scores for the WHOQOL-BREF domains in previous studies [11, 33]. In this study, the baseline characteristics showed no differences between the diagnostic groups (see Table 2). Hence, we analyzed both diseases together.
A strength of this study is the usual care setting with only little inclusion and exclusion criteria. Consequently, the results are likely to be transferable to a large part of the patient group and daily regular medical care. In this regular care setting, the study was conducted with a RCT-design. To fortify the validity, a multiple imputation was performed.
The baseline assessment showed a significant difference between the two groups with respect to the level of education. Participants in the intervention group had a higher level of education compared to participants in the control group. A blinded scientist performed the allocation to the groups using a random allocation (block randomization) after the baseline assessment. However, the baseline characteristics showed similar values for all WHOQOL-domains for both groups (see Table 2). In fact, the intervention group had even slightly lower WHOQOL total score values. The intervention was largely standardized. Furthermore, the loss to follow-up was identical in both groups (see Fig. 2). Therefore, a systematic bias seems unlikely. The proportion of loss to follow-up at the six-month-follow-up was 24% in the invention group and 23% in the control group. Due to the size of the dropout rates, there might be an attrition bias [34, 35], but threshold levels for acceptable dropout-levels are not determined in guidelines yet [35]. Furthermore, distinct patient clienteles might require different levels. Because of the almost identical rates and because of the difficult patient clientele, we deem that potentially bias might be low. Besides, the loss to follow-up is similar to other reported dropout rates in the regarded patient groups [31].
Diagnoses were extracted from the patients’ files from the three recruiting psychiatric departments. In several cases, a clear diagnosis has not yet been made by the treating physicians. Therefore sometimes several diagnoses were applied here.
Medication and its side effects could possibly effect patients’ quality of life [11] and would have been informative, but these aspects were not included here. However, it is a relevant question. Hence, the influence of medication on various data collected within the Tecla study, including the quality of life aspect, is currently being evaluated.