Trial document





This trial has been registered retrospectively.
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  DRKS00008548

Trial Description

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Title

post stationary telemedical care of patients with severe psychiatric disorders

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Trial Acronym

Tecla

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Care concepts, in which psychiatric patients with depression, anxiety disorders, adjustment disorders or somatoform disorders received a telemedical service with regular telephone and SMS contacts in addition to usual care , showed good results. Now this concept will be tested also in patients with severe psychiatric diseases (schizophrenia, bipolar disorders and schizoaffective disorders).

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Brief Summary in Scientific Language

In a randomized controlled trail particpants in the interventions group receive every two weeks telephone calls and every week text messages from specially trained nurses over a period of 6 months. These interventions are in addition to the usual outpatient treatment. The participants in the control group receive only the usual care. The aim of the study is to to provide a seamless care and to avoid breaks in the treatment for psychiatric patients after discharge from psychiatric clinics. In particular, the patients medication adherence is essential for relapse prevention.
The primary endpoint is improved medication adherence in the intervention group at the time of the 6-month follow-up compared to the control group.
Secondary research questions deal with frequency and periods of unplanned re-admissions to inpatient treatment.

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Organizational Data

  •   DRKS00008548
  •   2015/05/21
  •   [---]*
  •   yes
  •   Approved
  •   BB 122/14, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F20
  •   F25.SCHIZOAFFEKTIVESTOERUNGEN
  •   F31.BIPOLARESTOERUNGEN
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Interventions/Observational Groups

  •   Intervention group:
    All subjects received a baseline interview. It assess among others the medication adherence with MARS-D, but also the quality of life (WHOQOL).
    Intervention: Every two weeks telephone contacts by telephone carers (specially trained nurses): mixture of free discussion on topics about which patients should talk and standardized interview to thoughts on suicide, medication and side effects of drugs.
    In addition, weekly SMS contacts.
    Follow-up interviews after 3 and 6 months. In addition to MARS-D and WHOQOL also utilization of outpatient and inpatient care in the last 3 or 6 months is requested.
    Duration of the intervention: 6 months
  •   Control group:
    All subjects received a baseline interview. It assess among others the medication adherence with MARS-D, but also the quality of life (WHOQOL). Participants in the control group receive regular outpatient care.
    Follow-up interviews after 3 and 6 months. In addition to MARS-D and WHOQOL also utilization of outpatient and inpatient care in the last 3 or 6 months is requested.
    Duration of the intervention: 6 months
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the evaluation medication adherence. The assesssment instrument is the MARS-D (German version of the Medication Adherence Report Scale). Times of measurement are baseline, 3- and 6-months-follow ups. The hypothesis is that after 6 months, the medication adherence in the intervention group is better than the control group.

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Secondary Outcome

Secondary endpoints compare the frequency of anew and unplanned psychiatric (partly) inpatient stays, the periods until the unplanned (partly) inpatient treatment as well as quality of life, coping with everyday life and the development of symptoms within each of the 6 months.
Data of unplannend readmissions are recorded with computer assistance. The quality of life is measured by the questionnaire WHOQOL-BREF (World Health Organsiation Quality Of Life), coping with everyday life with GAF (Global Assessment of Functioning) and symptoms with BPRS (Brief Psychiatric Rating Scale). Measurement times are baseline, 3- and 6-month follow-ups.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/01/30
  •   190
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria


Medical diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder. Signed consent to study participation.

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Exclusion Criteria


Planned hospitalization in the next 6 months. No telephone access.

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Addresses

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    • Universitätsmedizin Greifswald
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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    • Universitätsmedizin GreifswaldInstitut für Community Medicine
    • Ms.  PD Dr.  Neeltje  van den Berg 
    • Ellernholzstraße 1-2
    • 17487  Greifswald
    • Germany
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    • Universitätsmedizin GreifswaldInstitut für Community Medicine
    • Ms.  PD Dr.  Neeltje  van den Berg 
    • Ellernholzstraße 1-2
    • 17487  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Damp Stiftungc/o NGEG Norddeutsche Grundstücksentwicklungsgesellschaft
    • Mr.  Dr.  Niels  Bunzen 
    • Sell-Speicher, Wall 55
    • 24103  Kiel
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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