Mental DisorderNCT03320720
Evaluation of Home Treatment for Acute Psychiatric Care
A study testing Home Treatment and Treatment-as-usual in people with Mental Disorder, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial summary
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Home Treatment and Treatment-as-usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2017to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need for acute psychiatric inpatient care
- Residence in Zurich city
- Health insurance for Home Treatment
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Hospital Zurich
Zurich, Canton of Zurich, 8032
Matthias Jäger, MD, 0041 44 384 26 37, matthias.jaeger@puk.zh.ch
PhD, 0041 44 384 34 41, matthias.jaeger@puk.zh.ch
About this study
Official title: Evaluation of Home Treatment for Acute Psychiatric Care of the Psychiatric University Hospital Zurich (Switzerland)
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.
Read the detailed description
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. Home treatment patients are visited by a mobile and multiprofessional care team at their homes. Additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. Following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. Further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed.
- Conditions
- Mental Disorder
- Being tested
- Home Treatment, Treatment-as-usual
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home TreatmentOther
Patients with acute mental illness in need of inpatient care are treated at their houses by a mobile and multiprofessional care team if their health condition permits.
Treatment-as-usualOther
Patients with acute mental illness in need of inpatient care are treated in a psychiatric clinic.
| Study group | Role | What they receive |
|---|---|---|
| Home Treatment | Experimental | Patients with acute mental illness are treated at their houses by a mobile and multiprofessional care team instead of being treated as inpatients if their medical condition permits. Receives: Other: Home Treatment |
| Treatment-as-usual | Active comparator | Patients with acute mental illness are treated as inpatients in a psychiatric clinic. Receives: Other: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient days
Number of inpatient days per patient
Measured: 2 years follow-up
Secondary outcomes (8)
Total days in treatment
Total days in Treatment per patient = inpatient and home treatment
Measured: 2 years follow-up
Treatment costs
Calculated direct treatment costs
Measured: 2 years follow-up
Rehospitalization rate
Number of rehospitalizations per patient and duration until rehospitalization
Measured: 2 years follow-up
Adverse events
e.g. suicide or attempted suicide
Measured: 2 years follow-up
Global Assessment of Functioning Scale (GAF)
Scale measures social, occupational and psychological functioning and ranges from 0 to 100 (higher values mean better outcome).
Measured: 2 years follow-up
Health of the Nation Outcome Scale (HoNOS)
Scale measures the severity of symptoms and ranges from 0 to 48 (higher values mean worse outcome).
Measured: 2 years follow-up
Clinical Global Impression Scale (CGI)
Scale measures the severity of symptoms, global improvement and therapeutic response and ranges from 0 to 7 (higher values mean worse outcome).
Measured: 2 years follow-up
Patients' satisfaction
Patients' satisfaction assessed by the official questionnaire of the national association of the quality development in hospitals (ANQ)
Measured: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Jäger, Psychiatric University Hospital, Zurich
- Investigators
- Matthias Jäger, MD, Principal investigator, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320720
- Sponsor's protocol ID
- HT201701349
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Home Treatment for Acute Psychiatric Care of the Psychiatric University Hospital Zurich (Switzerland)
- ClinicalTrials.gov ID
- NCT03320720
- Acronym / sponsor ID
- HT201701349
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.
Detailed description
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. Home treatment patients are visited by a mobile and multiprofessional care team at their homes. Additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. Following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. Further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Treatment | Experimental | Other: Home TreatmentPatients with acute mental illness are treated at their houses by a mobile and multiprofessional care team instead of being treated as inpatients if their medical condition permits. |
| Treatment-as-usual | Active comparator | Other: Treatment-as-usualPatients with acute mental illness are treated as inpatients in a psychiatric clinic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Need for acute psychiatric inpatient care
- Residence in Zurich city
- Health insurance for Home Treatment
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home TreatmentPatients with acute mental illness in need of inpatient care are treated at their houses by a mobile and multiprofessional care team if their health condition permits. | Other | Home Treatment |
| Treatment-as-usualPatients with acute mental illness in need of inpatient care are treated in a psychiatric clinic. | Other | Treatment-as-usual |
Primary outcome
Inpatient days
Time frame: 2 years follow-up
Number of inpatient days per patient
8 secondary outcomes
Total days in treatment
Time frame: 2 years follow-up
Treatment costs
Time frame: 2 years follow-up
Rehospitalization rate
Time frame: 2 years follow-up
Adverse events
Time frame: 2 years follow-up
Global Assessment of Functioning Scale (GAF)
Time frame: 2 years follow-up
Health of the Nation Outcome Scale (HoNOS)
Time frame: 2 years follow-up
Clinical Global Impression Scale (CGI)
Time frame: 2 years follow-up
Patients' satisfaction
Time frame: 2 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Jäger, MD principal investigator
Psychiatric University Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Treatment and Treatment-as-usual in people with Mental Disorder, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Jäger, MD (0041 44 384 26 37, matthias.jaeger@puk.zh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient days (time frame: 2 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.