BackgroundCohort studies and registries rely on massive amounts of personal medical data. Therefore, data protection and information security as well as ethical aspects gain in importance and need to be considered as early as possible during the establishment of a study. Resulting legal and ethical obligations require a precise implementation of appropriate technical and organisational measures for a Trusted Third Party.MethodsThis paper defines and organises a consistent workflow-management to realize a Trusted Third Party. In particular, it focusses the technical implementation of a Trusted Third Party Dispatcher to provide basic functionalities (including identity management, pseudonym administration and informed consent management) and measures required to meet study specific conditions of cohort studies and registries. Thereby several independent open source software modules developed and provided by the MOSAIC project are used. This technical concept offers the necessary flexibility and extensibility to address legal and ethical requirements of individual scenarios.ResultsThe developed concept for a Trusted Third Party Dispatcher allows mapping single process steps as well as individual requirements and characteristics of particular studies to workflows, which in turn can be combined to model complex Trusted Third Party processes. The uniformity of this approach permits unrestricted re-combination of the available functionalities (depending on the applied software modules) for various research projects.ConclusionThe proposed approach for the technical implementation of an independent Trusted Third Party reduces the effort for scenario specific implementations as well as for maintenance. The applicability and the efficacy of the concept for a workflow-driven Trusted Third Party could be confirmed during the establishment of several nationwide studies (e.g. German Centre for Cardiovascular Research and the National Cohort).

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 Low levels of physical activity (PA) and high levels of physical inactivity (PI) are associated with higher mortality and cardiovascular diseases. Higher age is associated with a decrease of PA, only 2.4–29% of ≥60 year-olds achieve the PA times recommended by WHO. The aim of this study was to identify levels of and determinants for moderate PA, overall PA and PI in a sample of individuals aged ≥65 years. Methods We analyzed baseline data from an intervention-study aiming to increase PA and decrease PI by automatically generated feedback letters to objectively measured PA and PI. Recruitment was multimodal including re-contacting participants of previous studies and advertisements in regional public buses and newspapers. At baseline, participants wore an accelerometer over a period of 7 consecutive days. PA was categorized using cut-points suggested by Freedsoon 1998 in light, moderate and vigorous physical intensity as well as physical inactivity. Potential determinants (self-efficacy, education) were measured by questionnaires or in a physical examination (BMI). Multiple linear regression models were fitted to identify determinants for PA and PI. Results N = 199 persons (mean age 71.0 years (SD 4.9), 59.3% female) participated in the study. The weekly amount of overall PA for men was on average 1,821 minutes (SD 479.1), for women on average 1,929 minutes (SD 448.8). 79.7% of the women and 72.8% of the men achieved the WHO recommendation of 30 minutes moderate PA/day at baseline. The time of PI during the observation time period of 7 days was on average 4,057 minutes in men and 3,973 minutes in women. In males, age was found to be a significant negative determinant for overall PA (p = 0.002) and for moderate PA (p<0.001). Higher education was positively associated with higher levels of overall PA (p = 0.013) and moderate PA (p = 0.06) in men. BMI was a significant negative determinant for overall PA both in men (p = 0.039) and women (p = 0.032) as well as for moderate PA for women (p = 0.009). Only in women, not in men, self-efficacy was to be a significant positive determinant for overall PA (p = 0.020) as well as negatively associated with PI (p = 0.006). Discussion The participants of our study showed high levels of PA. This is likely due to selection bias in this convenience sample. However, also levels of PI are very high and those correspond with average levels in the German population. The determinants for higher PA and lower PI differed between males and females. Thus, strategies for improving PA and decrease PI are likely different with respect to sex and should take individual factors (e.g. age, BMI) into account. Trial registration number DRKS00010410 Date: 17 May 2017

Background Lack of physical activity (PA) and a high level of physical inactivity (PI) are associated with a higher risk for mortality and responsible for several non-communicable diseases including cardiovascular disease. Higher age is associated with a decrease of PA and an increasing level of PI. Studies have shown that interventions in the elderly have the potential to increase the amount of PA and to decrease the level of PI. However, most interventions are complex, elaborated, time- and resource-consuming. Here, we examined the effect of individual feedback-letters reporting the measured PA and PI in a sample of elderly people in Germany. Primary outcomes of the study were overall PA and PI after 6 months in the intervention group compared to a control group. Methods We examined data from the MOVING intervention study (RCT) for people aged ≥ 65 years living in the northeast of Germany. At baseline, 3 and 6-months follow-up, all study participants wore a 3-axis accelerometer over a period of seven consecutive days. After the baseline measurement, the participants were randomized into intervention and control group. Participants in the intervention group received automatically generated, individualized feedback letters reporting their PA and PI by mail after the baseline measurement and after the 3-months follow-up. A Two-Way Mixed ANOVA with repeated measures was calculated with light, moderate and overall PA as well as PI as dependent variables, and group (between subject) and time (inner subject) as factors. The analysis based on retrospective data from the MOVING study (2016–2018). Results N = 258 patients were recruited. N = 166 participants could be included in the analysis, thereof N = 97 women (58.4%). The mean age was 70.8 years (SD 4.8). At baseline, the participants had a mean wearing time of 5,934.5 minutes (SD = 789.5) per week, which corresponds to about 14 hours daily on average. The overall PA in the intervention group at the 6-months follow up was 2488.8 (95% CI 2358.9–2618.2) minutes and 2408.2 (95% CI 2263.0–2553.4) minutes in the control group. There was no statistically significant interaction effect (time*group) between the intervention and control group for the depending variables. Sensitivity analyses showed significant small positive effects of the interaction time*partnership, F(2, 300) = 3.020, p = 0.05, partial η2 = 0.020. Discussion On average, study participants had high levels of PA at baseline and showed a good adherence in wearing the accelerometer. Both is likely due to selection in the convenience study sample. Thus, some ceiling effect reduced the overall intervention effect somewhat. At baseline, the weekly average of PI was 3436.7 minutes, which correspondents to about 8.2 hours per day and about 57% of participants’ daily waking time. The average level of PI could be slightly decreased in both study groups. Trial registration number DRKS00010410, 17 May 2017.