|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00017577 |
|
Date of registration:
|
23/10/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): a cluster randomised controlled study
|
|
Scientific title:
|
Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): a cluster randomised controlled study - IMPPETUS |
|
Date of first enrolment:
|
28/10/2019 |
|
Target sample size:
|
500 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00017577 |
|
Study type:
|
interventional |
|
Study design:
|
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Markus
Kösters |
|
Address:
|
Lindenallee 2
89312
Günzburg
Germany |
|
Telephone:
|
+49 8221 96-29209 |
|
Email:
|
Markus.Koesters@ukdd.de |
|
Affiliation:
|
Universität Ulm, Klinik für Psychiatrie und Psychotherapie II, BKH Günzburg |
|
|
Name:
|
Johanna
Breilmann |
|
Address:
|
Lindenallee 2
89312
Günzburg
Germany |
|
Telephone:
|
+49 8221 96-29204 |
|
Email:
|
johanna.breilmann@uni-ulm.de |
|
Affiliation:
|
Universität Ulm, Klinik für Psychiatrie und Psychotherapie II, BKH Günzburg |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Inpatients and day hospital patients; patients with schizophrenia, schizotypal and delusional disorders (ICD-10 F2x) or Mood [affective] disorders (ICD-10 F3x); disease duration of = 2 years; considerable consequences on activities of daily life (‘Global Assessment of Functioning’ (GAF) score = 60 and a ‘Health of the Nation Outcome Scales’ (HoNOS) Score of = 2 on one of the items of the subscale for symptomatic problems (item 6, 7, and 8) and a score of = 2 on each of the four items of the subscale for social problems (items 9, 10, 11, and 12) or a score of = 3 on at least one of these items (9, 10, 11, or 12)) // relatives of patients with mental disorders: both sexes, age >= 18 years
Exclusion criteria: Patients and relatives who are not able to consent; Patients and relatives who are unable to understand answer the questions/study; Relatives when they are in inpatient or day hospital mental health care
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
F20-F29
|
|
Schizophrenia, schizotypal and delusional disorders
|
|
Mood [affective] disorders
|
|
F30-F39
|
F20-F29
F30-F39
|
|
Intervention(s)
|
Group 1: Multimodal implementation of the patient-guideline "Psychosocial interventions for patients with severe mental illness".
Group 2: Treatment as usual + Information flyer for the patient-guideline "Psychosocial interventions for patients with severe mental illness."
|
|
Primary Outcome(s)
|
|
The primary outcome is the change of empowerment after 6 month, which will be measured using the 'empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders (EPAS)' scale.
|
|
Secondary Outcome(s)
|
|
(1) Changes in participants' knowledge, attitudes, and experiences regarding available treatments will be assessed using a checklist developed for this study, listing all psychosocial interventions of the S3 guideline ‘psychosocial interventions’. Measurement at t0 (baseline), t1 (post-intervention), t2 (6 month after baseline). (2) Changes in service use will be measured using the 'Client Sociodemographic and Service Receipt Inventory’ (CSSRI). Measurement at t0, t2. (3) A higher satisfaction with treatment will be assessed using the German satisfaction questionnaire ‘ZUF-8’. Measurement at t0, t1 , t2. (4) Changes in treatment needs and coverage of needs of the patients will be assessed by using the ‘Camberwell Assessment of Need’ (CAN-EU). Measurement at t0, t2. (5) An improvement of the Quality of life (QOL) will be measured using the World Health Organization’s Quality of Life Instrument-abbreviated version (WHOQOL-BREF). Measurement at t0, t2. (6) The calculation of quality-adjusted life years (QALY) will be based on the EuroQol (EQ-5D-5L). Measurement at t0, t2. (7) In addition, the participation and social inclusion of the patients will be assessed using the German questionnaire ‘Fragebogen zur Erfassung sozialer Partizipation und sozialer Inklusion chronisch psychisch erkrankter Menschen’ (F-INK). Measurement at t0, t2. (8) Sociodemographic data (e.g. sex, age, and socioeconomic data) and patient’s medical history will be assessed within the CSSRI.
|
|
Source(s) of Monetary Support
|
|
Innovationsfond des Gemeinsamen Bundesausschusses (G-BA)
|
|
Ethics review
|
Status: Approved
Approval date: 09/10/2019
Contact:
ethik-kommission@uni-ulm.de
Ethikkommission der Universität Ulm
+49-731-50022050
ethik-kommission@uni-ulm.de
|
|