title: Tecla: a telephone- and text-message based telemedical concept for patients with severe mental health disorders--study protocol for a controlled, randomized, study.
abstract: BACKGROUND
  Severe 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
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  This study is registered at 2015\05\21 at the German Clinical Trials Register DRKS00008548.
authors.affiliation: Institute for Community Medicine, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. ulrike.stentzel@uni-greifswald.de.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Stentzel
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. grabeh@uni-greifswald.de.
authors.forename: Hans-Jörgen
authors.initials: HJ
authors.lastname: Grabe
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. lara.strobel@uni-greifswald.de.
authors.forename: Lara
authors.initials: L
authors.lastname: Strobel
authors.affiliation: Institute for Community Medicine, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. peter.penndorf@uni-greifswald.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Penndorf
authors.affiliation: Bethanien Hospital for Psychiatry, Psychosomatics and Psychotherapy, Gützkower Landstraße 69, 17489, Greifswald, Germany. langosch@odebrecht-stiftung.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Langosch
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. freyberg@uni-greifswald.de.
authors.forename: Harald J
authors.initials: HJ
authors.lastname: Freyberger
authors.affiliation: Institute for Community Medicine, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. wolfgang.hoffmann@uni-greifswald.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hoffmann
authors.affiliation: Institute for Community Medicine, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany. neeltje.vandenberg@uni-greifswald.de.
authors.forename: Neeltje
authors.initials: N
authors.lastname: van den Berg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001714:Bipolar Disorder / Q000628:therapy; D002908:Chronic Disease; D005858:Germany; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D055118:Medication Adherence; D001523:Mental Disorders / Q000628:therapy*; D008875:Middle Aged; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000628:therapy; D011788:Quality of Life; D012559:Schizophrenia / Q000628:therapy; D017216:Telemedicine / Q000379:methods*; D013689:Telephone; D060145:Text Messaging; D055815:Young Adult