BackgroundSevere mental disorders like psychotic disorders including schizophrenia and schizoaffective disorders have a 12-month-prevalence of 2.6, bipolar disorders of 1.5 % in Germany. The relapse risk is high; so many patients need intensive monitoring and lifelong treatment. A high medication adherence is essential for a successful treatment. But in practice, medication adherence is low and decreases over time. Telemedical care concepts might improve treatment and bridge gaps between in- and outpatient treatment.A telemedical care concept based on regular telephone calls and short text messages was developed. The primary objective is to assess whether regular telephone calls and text messages can improve the medication adherence of patients. Secondary objectives are the reduction of rehospitalization rates, the improvement of quality of life and of the severity of symptoms.Methods/designThe Tecla study (Post stationary telemedical care of patients with severe psychiatric disorders) is a two-armed prospective randomized controlled trial. The participants in the intervention group receive in addition to usual care regular telephone calls every 2 weeks and weekly text messages on patient-individual topics during a 6 months period. Patients in the control group receive only regular care. Inclusion criteria are a physician-diagnosed bipolar disorder, schizoaffective disorder or schizophrenia and a signed informed consent. Exclusion criteria are planned inpatient treatments within the next 6 months and being non-reachable by phone. After 3 and 6 months both groups receive follow up assessments.DiscussionThe primary objective of this study is the medication adherence that is measured with the Medication Adherence Report Scale, German version (MARS-D). The MARS-D is a self-report with five items. Adherent behaviour is mostly overestimated using self-reports. The strength of the MARS-D is to detect non-adherent behaviour. The original Medication Adherence Report Scale in English language (MARS-5) was developed to encourage the patient to answer truthfully to the questions that are asked in a non-threatening and non-judgmental way to minimize social desirability bias in admitting non-adherent behaviour.Trial registrationThis study is registered at 2015\05\21at the German Clinical Trials Register DRKS00008548.

Background: Schizophrenia and bipolar disorder are serious psychiatric disorders with a high disease burden, a high number of years of life lived with disability and a high risk for relapses and re-hospitalizations. Besides, both diseases are often accompanied with a reduced quality of life. A low level of quality of life is one predictor for relapses. This study examines whether a telemedical care program can improve quality of life.Methods: Post stationary telemedical care of patients with severe psychiatric disorders” (Tecla) is a prospective controlled randomized intervention trial to implement and evaluate a telemedical care concept for patients with schizophrenia and bipolar disorder. Participants were randomized to an intervention or a control group. The intervention group received telemedical care including regular, individualized telephone calls and SMS-messages. The quality of life was measured with the German version of the WHOQOL-BREF. Effects of telemedicine on quality of life after 6 months were analyzed using t-tests to compare the intervention with the control group. Participants also evaluated the telemedical care program based on a short standardized interview.Results: 118 participants were recruited, thereof 57.6 % men (n = 68). Participants were on average 43 years old (SD) 13). Linear mixed model revealed that affiliation to patient group (0 = CG, 1 = IG), gender (0 = female, 1 = male), increasing social support and higher GAF-level are positive significant influence factors for the WHOQOL total quality of life, physical, psychological, environmental and global domain. An increasing education often showed significantly decreasing quality of life values. Age as an influencing factor, showed different results on the sum score and the individual domains.Conclusion: The Tecla telemedical care concept has improved the quality of life in patients with severe psychiatric disorders. It provides for a low-threshold and well suitable component in psychiatric treatment.Trial registration: German Clinical Trials Register, DRKS00008548, registered 21 May 2015 – retrospectively registered, https://www.drks.de/drks_web/setLocale_EN.do

Background: Schizophrenia and bipolar disorder are serious psychiatric disorders with a high disease burden, many years lived with disability and a high level of risk of relapses and re-hospitalisations. Besides, both diseases are often accompanied with a reduced quality of life. A low quality of life is one predictor for relapses. This study examines whether a telemedical care programme can improve quality of life. Methods: “Post stationary telemedical care of patients with severe psychiatric disorders” (Tecla) is a prospective controlled randomised intervention trial to implement and evaluate a telemedical care concept for patients with schizophrenia and bipolar disorder. Participants were randomised in an intervention or a control group. The intervention group received telemedical care including regular, individualised telephone calls and SMS messages. The quality of life was measured with the German version of WHOQOL-BREF. Effects of telemedicine on quality of life after 6 months were analysed using t-tests to compare the intervention with the control group. Participants also evaluated the telemedical care program based on a short standardised interview.Results: 118 participants were recruited, thereof 57.6% men (n = 68). Participants were 43 years old on average (SD) 13)). The IG showed higher QoL scores than the control group (CG) 6 months after the baseline for the WHOQOL total sum score (t-test (CI) 93.1 (92.4-93.8) vs 89.7 (88.8-90.6), p < 0.0001) and for 4 of 5 domains: global 62.0 (60.9-63.0) vs. 56.8 (55.6-58.1), p < 0.0001; physical health 63.8 (63.0-64.7) vs. 59.6 (58.5-60.6), p < 0.0001; psychological 60.9 (60.0-61.9) vs. 56.4 (55.1-57.6), p < 0.0001; environment 70.8 (70.1-71.6) vs. 67.5 (66.7-68.3), p < 0.0001).Conclusion: The Tecla telemedical care concept has led to improvements in quality of life for patients with severe psychiatric disorders. It provides a low-threshold and suitable component of psychiatric treatment. Trial registration: German Clinical Trials Register, DRKS00008548, registered 21 May 2015 – retrospectively registered, https://www.drks.de/drks_web/setLocale_EN.do