Mental DisordersNCT01719354
Aftercare in the Community Health Center
A study testing Community Health center in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This is a trial to examine the effects of aftercare for mental health patients in community health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric hospitals (Østmarka). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Community Health center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- considered by the responsible manager to have given consent
- hospitalized, diagnosed and treated such as can be continued in a District Psychiatric Service or a health center.
- stable condition, but anxiety and disruptive behavior may occur to a lesser extent.
- considered to have a perceived need for complex services from specialist health and community for a long time after discharge.
Who cannot join
- not in a stable phase thus shielding required
Trial locations and contacts
1 site in 1 country.
Norway1 site
Regional Committees for Medical and Health Research Ethics
Trondheim, 7489
About this study
Official title: Aftercare in the Community Health Center - a Venue for Identifying and Coordinating Community Services
This is a trial to examine the effects of aftercare for mental health patients in community health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two groups: intervention group (community health center, primary care) or control group (Community mental health centers of District Psychiatric Service, specialist care).
The project's primary objective is to investigate the effect of community services on patients' functional capacity and user satisfaction after discharge. Secondly, the number of treatment days and readmissions to mental health care will be examined. The project will also compare costs of hospitalization, in psychiatric hospital and community health center respectively. Data will be collected from community health records, medical records and patient systems in psychiatric hospital, community mental health centers of District Psychiatric Service (DPS) and questionnaires filled out by patients.
- Conditions
- Mental Disorders
- Being tested
- Community Health center, Control
- Keywords
- Community Mental Health Centers, Norway, Aftercare
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health centerOther
Observation of the functioning and coordination of health care before discharge to own home.
ControlOther
standard aftercare in hospital/mental health centers of District Psychiatric Service (DPS).
| Study group | Role | What they receive |
|---|---|---|
| Community Health center | Experimental | Aftercare in a community Health center Receives: Other: Community Health center |
| Control | Active comparator | AFtercare as usual in hospital/Mental health centers of District Psychiatric Service (DPS. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of community health service
Measure different types of community health services in hours per week.
Measured: one year
Need for community health services
Using IPLOS (Norw. individual-based nursing and care statistics) form with 17 variables to identify patient needs
Measured: one year
User satisfaction
A qualitative analysis of interviews of 10 patients who have been admitted to the District Psychiatric Service and community health center.
Measured: one year
Need for community health services
Using individual-based nursing and care statistics (Norw. IPLOS) form with 17 variables to identify patient needs
Measured: one year
Secondary outcomes (3)
Number of treatment days
Number of treatment days in hospital and District Psychiatric Service compared with number of treatment days in community health center.
Measured: One year
Readmission
Readmission in hospital.
Measured: One year
The total costs of inpatient and total costs of all health care after discharge
Costs per day in hospital; Costs per day for District Psychiatric Service; Costs per day in community health center
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, prof, Study director, NTNU, Department of Public Health and General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719354
- Sponsor's protocol ID
- 2011/1770
- Status last verified
- Feb 2017
- First submitted
- 30 Oct 2012
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Roos E, Bjerkeset O, Steinsbekk A. Health care utilization and cost after discharge from a mental health hospital; an RCT comparing community residential aftercare and treatment as usual. BMC Psychiatry. 2018 Nov 12;18(1):363. doi: 10.1186/s12888-018-1941-2.
PubMed 30419894
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aftercare in the Community Health Center - a Venue for Identifying and Coordinating Community Services
- ClinicalTrials.gov ID
- NCT01719354
- Acronym / sponsor ID
- 2011/1770
- Conditions
- Mental Disorders
- Keywords
- Community Mental Health Centers, Norway, Aftercare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2013 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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.
This is a trial to examine the effects of aftercare for mental health patients in community health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two groups: intervention group (community health center, primary care) or control group (Community mental health centers of District Psychiatric Service, specialist care).
The project's primary objective is to investigate the effect of community services on patients' functional capacity and user satisfaction after discharge. Secondly, the number of treatment days and readmissions to mental health care will be examined. The project will also compare costs of hospitalization, in psychiatric hospital and community health center respectively. Data will be collected from community health records, medical records and patient systems in psychiatric hospital, community mental health centers of District Psychiatric Service (DPS) and questionnaires filled out by patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health center | Experimental | Other: Community Health centerAftercare in a community Health center |
| Control | Active comparator | Other: ControlAFtercare as usual in hospital/Mental health centers of District Psychiatric Service (DPS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- considered by the responsible manager to have given consent
- hospitalized, diagnosed and treated such as can be continued in a District Psychiatric Service or a health center.
- stable condition, but anxiety and disruptive behavior may occur to a lesser extent.
- considered to have a perceived need for complex services from specialist health and community for a long time after discharge.
Key exclusion criteria (1 listed)
- not in a stable phase thus shielding required
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 |
|---|---|---|
| Community Health centerObservation of the functioning and coordination of health care before discharge to own home. | Other | Community Health center |
| Controlstandard aftercare in hospital/mental health centers of District Psychiatric Service (DPS). | Other | Control |
Primary outcome
Consumption of community health service
Time frame: one year
Measure different types of community health services in hours per week.
Need for community health services
Time frame: one year
Using IPLOS (Norw. individual-based nursing and care statistics) form with 17 variables to identify patient needs
User satisfaction
Time frame: one year
A qualitative analysis of interviews of 10 patients who have been admitted to the District Psychiatric Service and community health center.
Need for community health services
Time frame: one year
Using individual-based nursing and care statistics (Norw. IPLOS) form with 17 variables to identify patient needs
3 secondary outcomes
Number of treatment days
Time frame: One year
Readmission
Time frame: One year
The total costs of inpatient and total costs of all health care after discharge
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Derived from this study: PubMed 30419894Roos E, Bjerkeset O, Steinsbekk A. Health care utilization and cost after discharge from a mental health hospital; an RCT comparing community residential aftercare and treatment as usual. BMC Psychiatry. 2018 Nov 12;18(1):363. doi: 10.1186/s12888-018-1941-2.
Related trials for Mental Disorders
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.
Aslak Steinsbekk, prof study director
NTNU, Department of Public Health and General Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health center in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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: finished, as of the sponsor's last update on 14 Feb 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of community health service (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719354, which also lists 1 linked publication.
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 14 Feb 2017.