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

Abstract

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.

Predictors of medication adherence among patients with severe psychiatric disorders: findings from the baseline assessment of a randomized controlled trial (Tecla)

“…Adverse drug effects were assessed using a 5 category Likert-scale including “no side effects”, “little”, “moderate”, “strong” and “very strong” for each of the following side effects: movement disorders, muscle stiffness, involuntary shiver, motionlessness, muscle spasm, agonizing restlessness/problems to sit still (can’t be suppressed at will), lack of sexual desire/loss of libido, increase in weight, increased appetite, heavy feeling of illness/chills/fever and milk flow [ 34 ].…”

Translation and initial validation of the Medication Adherence Report Scale (MARS) in Italian patients with Crohn’s Disease

“…It is a generic tool, which can be administered regardless of the disease and the prescribed drug. It has been validated so far in different clinical settings, namely statin therapy [15], rheumatoid arthritis [16], asthma [17], psychosis [18], and has been used for assessing adherence in many clinical studies worldwide [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37].…”

Telemedical care improves quality of life in patients with schizophrenia and bipolar disorder. Results of a randomized controlled trial

“…Tecla has been approved by the Ethics Committee of the University Medicine Greifswald (BB 122 /14) and was registered on the German Clinical Trials Register (date 2015\05\21, DRKS00008548). A comprehensive description of the study protocol for the Tecla study was published by Stentzel et al [14].…”

“…Tecla's objective was the implementation and evaluation of a telemedical care concept for patients with schizophrenia, schizoaffective disorder and bipolar disorder. It addressed different problems in treatment and everyday life management [14]. The primary outcome was medication adherence, which was positively influenced by the telemedical care concept [13].…”