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
About this trial
This is an interventional health services research trial for Schizophrenia
Eligibility Criteria
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
NCT ID
NCT02349880
First Posted
January 23, 2015
Last Updated
April 24, 2018
Sponsor
Technical University of Munich
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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