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  • Smartphone-based Aftercare for Inpatients With Bulimia Nervosa

    Bulimia nervosa (BN) is a severe mental disorder characterized by recurrent episodes of binge eating and recurrent inappropriate compensatory behaviors to prevent weight gain. Evidence-based psychological treatments exist, however, even if treatment is successful in reducing behaviors such as binge eating and purging, abstinence rates may remain low and even if remission or abstinence have been received after treatment relapse rates are substantial. There is evidence that the stability of remission increases if the corresponding symptom improvement lasts at least for 4 months. Studies on the effectiveness of inpatient treatment in adult patients with BN show responder rates of up to 77%. However, it is often difficult for patients to maintain therapy success after discharge, as relapse rates reach up to 40% with the highest risk during the first 5 or 6 months after remission. There is preliminary evidence for efficacy regarding the potential of technology-based interventions in aftercare for patients with BN. However, so far, there is no study evaluating a smartphone-based aftercare intervention for patients with BN. Therefore, the aim of this study is to investigate the efficacy of a guided smartphone-based aftercare intervention as an add-on element to treatment as usual (TAU) compared to TAU alone in inpatients with BN. Our primary hypothesis is that the intervention group shows a significantly higher remission rate than TAU at end of treatment. Eligible patients with BN who are discharged from inpatient treatment will be randomized either to receive a 4-month smartphone-based aftercare intervention with therapist feedback as an add-on element to treatment as usual (TAU) or TAU alone. Assessment points will be as follows: at hospital discharge (=baseline, T0), 16 weeks (=end of the aftercare intervention, T1) and after 10 months (=6-month follow-up, T2).

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    Ludwig-Maximilians - University of Munich

    Bad Bevensen

    Recruiting

  • Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

    The purpose of this study is to assess whether efficacy of the MagicTouch® Sirolimus Coated PTA Balloon Catheter (SRL-DCB) is superior and whether safety is non-inferior to Plain Old Balloon Angioplasty (POBA) regarding treatment of high-grade stenoses ≥ 75 % in the infrapopliteal arteries (located below the P3 segment of the popliteal artery to the tibiotalar joint) in patients presenting with chronic limb-threatening ische-mia (CLTI) (Rutherford 4-6).

    Phase

    N/A

    Span

    347 weeks

    Sponsor

    Jena University Hospital

    Bad Bevensen

    Recruiting

  • Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation

    Anorexia nervosa (AN) is a comparably low-prevalent, yet due to its somatic and mental consequences serious illness. Chronic courses are often and the mortality rate of patients with AN is higher than in any other mental illness. A major influence on the course of the illness is the interval between the onset of AN symptoms and the beginning of an adequate treatment (duration of untreated illness, DUI). That is, patients with AN have a better prognosis if treated early. Previous large-scale interventions have not shown the desired positive effects on the DUI. Therefore, an important starting point seems to be a better initial understanding of the factors influencing the DUI, which is the major aim of this project. Based on this evidence, this study aims to derive recommendations for effective secondary prevention. To our very best knowledge this is the first study investigating factors influencing the DUI using a multi-informant strategy, that is exploring the perspective of patients with AN, their significant carers and involved physicians. Furthermore, the study will avoid the confounding of patients with different eating disorder diagnoses, i.e. it will include exclusively patients with AN. Finally, there will be a clear focus on factors which are modifiable and precise in their definition. The planned mixed-method study is divided in three consecutive sub-studies. The first substudy aims to identify modifiable factors influencing the DUI using semi-structured interviews and a multi-informant approach (patients, carers, physicians). As a result of this qualitative analyses using Grounded Theory the most relevant factors will be determined. The motivation of the second substudy is to condense the factors identified to influence the DUI into a checklist and to conduct a first psychometric evaluation of this newly developed instrument. The third substudy aims to quantitatively determine the magnitude of the effects of a) a priori determined non-modifiable factors and b) the modifiable checklist-factors using a multi-informant approach (planned n for each informant = 130; 13 co-operating specialized clinics and 6 cooperating outpatient partners). Additional outpatient partners may be recruited during the course of the study. In conclusion, the study aims to derive recommendations for effective secondary prevention. Thereby, the study might ultimately contribute to earlier treatment initiation of patients with AN, and to the prevention of chronic courses and the associated high health care costs and individual burden.

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    Universitätsklinikum Hamburg-Eppendorf

    Bad Bevensen

    Recruiting

  • Post-Market Clinical Follow Up Study With Navitor Valve

    The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

    Phase

    N/A

    Span

    431 weeks

    Sponsor

    Abbott Medical Devices

    Bad Bevensen

    Recruiting

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