- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745507
Implementation, Efficacy and Costs of Inpatient Equivalent Home-Treatment in German Mental Health Care (AKtiV)
Outreach Crisis Intervention With a Team-based and Integrative Model of Treatment (AKtiV Study): Evaluation of the Inpatient Equivalent HomeTreatment (IEHT According to the German Social Code Book §115d SGB V) - a Proof-of-Concept Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 12351
- Vivantes Neukölln, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
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Baden-Württemberg
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Reichenau, Baden-Württemberg, Germany, 78479
- Zentrum für Psychiatrie Reichenau
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Reutlingen, Baden-Württemberg, Germany, 72764
- PP.rt, Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH,
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Tübingen, Baden-Württemberg, Germany, 72076
- Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie
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Weißenau, Baden-Württemberg, Germany, 88214
- Klinik für Psychiatrie und Psychotherapie I der Universität Ulm (Weissenau),
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Zwiefalten, Baden-Württemberg, Germany, 88529
- • Zentrum für Psychiatrie Südwürttemberg, Klinik für Psychiatrie und Psychotherapie Zwiefalten
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Bayern
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Haar, Bayern, Germany, 85540
- kbo-Isar-Amper-Klinikum München-Ost
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Berlin
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Berlin-Kreuzberg, Berlin, Germany, 10967
- Vivantes Klinikum am Urban; Klinik für Psychiatrie, Psychotherapie und Psychosomatik
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Berlin-Mitte, Berlin, Germany, 10117
- • Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte,
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Brandenburg
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Rüdersdorf, Brandenburg, Germany, 15562
- Immanuel Klinik Rüdersdorf, Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Psychiatrische Hochschulklinik
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
C1: This cohort consists of patients who receive IEHT in the recruiting sites.
C2: This cohort consits of patients receiving standard inpatient care (treatment as usual / TAU) from the IEHT delivering hospital
C3: This cohort consits of close relatives or informal caregivers living in the same househod of the participating patients.
C4: Staff members of participatimg study cites as well as local and political stakeolders engaged with IEHT
Description
For C1 and C2:
Inclusion criteria:
IEHT inclusion criteria
- acute mental health crisis that requires inpatient treatment;
- social and living surrounding allowing for home visits and private conversations;
- informed consent of all adults living in the service user's place of residency;
- ability to provide informed consent
- sufficient German language skills
- permanent residence in the catchment area of the IEHT delivering Hospital
- main diagnosis within the ICD codes F0X, F1X, F2X, F3X, F4X, F5X, or F6X
Exclusion criteria:
IEHT exclusion criteria
o in case of children living in the same household, presence of child welfare risk
- acute suicidality or aggressiveness towards others requiring hospital admission
- Being under order of commitment
- participation in an interventional study during the recruitment
- presence of substantial cognitive deficits as indicated by severe organic brain disease
- diagnosis of intellectual impairment
- admission longer ago than 7 days
For C3: Close relative or informal caregiver living in the same household of the participating patient
Inclusion criteria:
• informed consent regarding study participation
For C4: IEHT staff member of participating study cite OR local or political stakeholder engaged with IEHT
Inclusion criteria:
• informed consent regarding study participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Arm 1 / C1
This cohort (C1) consists of 180 patients who receive IEHT in the recruiting sites, fulfil inclusion criteria and gave informed consent regarding their study participation.
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At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).
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Arm 2 / C2
This cohort (C2) consist of 180 patients receiving standard inpatient care (TAU) from the IEHT delivering hospital who fulfil inclusion criteria, are identified through a propensity score (PS) function as optimal control user or rather a "PS match" and gave informed consent regarding their study participation
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Arm 3
360 close relatives or informal caregivers living in the same household of the participating patients who gave informed consent regarding their study participation.
Thereby, one relative of each patients who is participating in the trial will be assessed (C1 = 180, C2 = 180).
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Arm 4:
Staff members of participating study cites as well as local and political stakeholders engaged with IEHT who gave informed consent (approximately n = 100 participants overall).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Differences and change in the hospital re-admission rate
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Observed Differences and change in the hospital re-admission of service users (C1 and C2) within 12 months after inclusion into the trial assessed via routine data of the study sites and the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined readmission (day clinic, IEHT or hospital)
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Combined readmission (day clinic, IEHT or hospital) of service users (C1 and C2) within 12 months after inclusion into the trial assessed via routine data of the study sites and the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Continuity of care
Time Frame: [Time Frame: (T0.1) within 7 days after admission, (T0.2) 7 days before or after discharge , (T1) 6 months after T0.1, (T2) 12 months after T0.1]
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The amount of service users (C1 and C2) dropping out of treatment after inclusion into the trial assessed via routine data of the study sites and the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
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[Time Frame: (T0.1) within 7 days after admission, (T0.2) 7 days before or after discharge , (T1) 6 months after T0.1, (T2) 12 months after T0.1]
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Total number of inpatient days
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Total number of inpatient days of service users (C1 and C2) after inclusion into the trial assessed via routine data of the study sites and the German Version of the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Generic health status
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Generic health status of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the EQ-5D-5L (Ludwig, von der Schulenburg, & Greiner, 2017).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Psychosocial functioning
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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The psychosocial functioning of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the Health of the Nation Outcome Scales (HoNOS-D; Andreas S. et. al., 2007).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Personal and Social functioning
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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The level Personal and Social functioning of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the Personal and Social Performance Scale (PSP; Schaub & Juckel, 2011).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Professional reintegration
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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The professional/work reintegration of service users (C1 and C2) after inclusion into the trial assessed via the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Personal Recovery
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Personal recovery of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the Recovery Assessment Scale (RAS-G; Cavelti et. al, 2016).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Cost-utility
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Cost-utility including direct and indirect disease related costs of service users (C1 and C2) after inclusion into the trial assessed via the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Quality-adjusted life year
Time Frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Quality-adjusted life years of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the EQ-5D-5L (Ludwig, von der Schulenburg, & Greiner, 2017)
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(T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
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Treatment satisfaction
Time Frame: (T0.2) 7 days before or after discharge
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The treatment satisfaction of service users (C1 and C2) assessed by a self developed questionnaire.
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(T0.2) 7 days before or after discharge
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Treatment satisfaction of close relatives or informal caregiver
Time Frame: (T0.2) 7 days before or after discharge
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The treatment satisfaction of close relatives or informal caregiver (C3) for both groups (C1 and C2) assessed by a self developed questionnaire.
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(T0.2) 7 days before or after discharge
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Burden of close relatives or informal caregiver
Time Frame: (T0.2) 7 days before or after discharge
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Burden of close relatives or informal caregiver (C3) for both groups (C1 and C2) assessed by via the German Version of the Involvement Evaluation Questionnaire (IEQ-EU; Bernert, et. al, 2001).
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(T0.2) 7 days before or after discharge
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sebastian von Peter, Prof. Dr., Immanuel Klinik Rüdersdorf
- Principal Investigator: Andreas Bechdolf, Prof. Dr., Vivantes Klinikum Am Urban
Publications and helpful links
General Publications
- Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer MC. [German adaptation of the client sociodemographic and service receipt inventory - an instrument for the cost of mental health care]. Psychiatr Prax. 2001 Oct;28 Suppl 2:S84-90. doi: 10.1055/s-2001-17790. German.
- Andreas S, Harfst T, Dirmaier J, Kawski S, Koch U, Schulz H. A Psychometric evaluation of the German version of the 'Health of the Nation Outcome Scales, HoNOS-D': on the feasibility and reliability of clinician-performed measurements of severity in patients with mental disorders. Psychopathology. 2007;40(2):116-25. doi: 10.1159/000098492. Epub 2007 Jan 11.
- Cavelti M, Wirtz M, Corrigan P, Vauth R. Recovery assessment scale: Examining the factor structure of the German version (RAS-G) in people with schizophrenia spectrum disorders. Eur Psychiatry. 2017 Mar;41:60-67. doi: 10.1016/j.eurpsy.2016.10.006. Epub 2016 Dec 31.
- Bernert S, Kilian R, Matschinger H, Mory C, Roick C, Angermeyer MC. [The assessment of burden on relatives of mentally ill people: the German version of the involvement evaluation questionnaire (IEQ-EU)]. Psychiatr Prax. 2001 Oct;28 Suppl 2:S97-101. doi: 10.1055/s-2001-17792. German.
- Ludwig K, von der Schulenburg JG, Greiner W. Valuation of the EQ-5D-5L with composite time trade-off for the German population - an exploratory study. Health Qual Life Outcomes. 2017 Feb 20;15(1):39. doi: 10.1186/s12955-017-0617-9.
- Schaub D, Juckel G. [PSP Scale: German version of the Personal and Social Performance Scale: valid instrument for the assessment of psychosocial functioning in the treatment of schizophrenia]. Nervenarzt. 2011 Sep;82(9):1178-84. doi: 10.1007/s00115-010-3204-4. German.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01VSF19048
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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