Tecla: a telephone- and text-message based telemedical concept for patients with severe mental health disorders – study protocol for a controlled, randomized, study

BMC Psychiatry

Study Protocol

Jens Langosch¹  Harald J. Freyberger²  Hans-Jörgen Grabe²  Lara Strobel²  Neeltje van den Berg³  Peter Penndorf³  Wolfgang Hoffmann³  Ulrike Stentzel³ 

[1] Bethanien Hospital for Psychiatry, Psychosomatics and Psychotherapy, Gützkower Landstraße 69, 17489, Greifswald, Germany;Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany;Institute for Community Medicine, University Medicine Greifswald, Ellernholzstraße 1-2, 17487, Greifswald, Germany;

关键词: Mental health disorders;    Schizophrenia;    Psychotic disorders;    Bipolar disorders;    Telemedical care;    Telemedicine;    Telephone;    Text messages;   

DOI  :  10.1186/s12888-015-0659-7

 received in 2015-09-30, accepted in 2015-10-20,  发布年份 2015

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Stentzel et al. 2015