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A Shared Decision-making Training for Inpatients With Schizophrenia

Primary Purpose

Schizophrenia, Schizo-affective Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
shared decision making training
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-65
  • icd diagnosis F2
  • sufficient German language skills

Exclusion Criteria:

  • debility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control

    intervention

    Arm Description

    5 hour cognitive training

    5 hour shared decision making training

    Outcomes

    Primary Outcome Measures

    adherence to antipsychotic medication

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2015
    Last Updated
    April 24, 2018
    Sponsor
    Technical University of Munich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02349880
    Brief Title
    A Shared Decision-making Training for Inpatients With Schizophrenia
    Official Title
    A Shared Decision-making Training for Inpatients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Technical University of Munich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    "Shared decision-making" is being promoted as a promising approach for engaging patients with schizophrenia in medical decisions and improving satisfaction and adherence. To implement shared decision-making, both physicians and patients should commit to it and engage in a mutual decision process. Most research, however, has addressed interventions that either focus on the doctors' side (e.g. "communication skills") or on informing patients about treatment options (e.g. "decision aids"). These approaches have been shown to be feasible in clinical practice but had no strong effects on treatment patterns or adherence, possibly because they were insufficient to motivate and enable patients to engage actively in decision-making. Moreover, these interventions still rely on the doctor's willingness to share decisions, which has been shown to vary considerably. To overcome these limitations and since many patients do not feel competent to participate in decision-making we developed an intervention that focuses on patients' communicative competencies. this intervention, a five session group-training, will be implemented for inpatients suffering from schizophrenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizo-affective Disorder

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    264 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    5 hour cognitive training
    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    5 hour shared decision making training
    Intervention Type
    Behavioral
    Intervention Name(s)
    shared decision making training
    Primary Outcome Measure Information:
    Title
    adherence to antipsychotic medication
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18-65 icd diagnosis F2 sufficient German language skills Exclusion Criteria: debility

    12. IPD Sharing Statement

    Learn more about this trial

    A Shared Decision-making Training for Inpatients With Schizophrenia

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