Patient-controlled AdmissionsNCT04862897
Patient-controlled Admissions to Inpatient Care
An observational study of Patient-controlled Admissions and Matched Control Group, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Patient-controlled admissions refer to the possibility for patients with severe psychiatric conditions to admit themselves to inpatient care. Compared to having the healthcare providers make this decision, patient-controlled admissions are believed to decrease the need for involuntary care, decrease symptom levels… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Patient-controlled Admissions, Matched Control Group
- How many people
- 564 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 31 Aug 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with severe psychiatric conditions in Region Stockholm who fulfil the inclusion criteria can be provided access to patient-controlled admissions. This includes child and adolescent psychiatry, but excludes forensic psychiatry and addiction care. All patients who receives patient-controlled admissions and a matched control group will be evaluated regarding all primary outcome measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions. For the remaining secondary outcomes measures (i.e., self-reported outcomes), only those patients who consent to participate in the research project will be evaluated.
Who may be able to join
- Have an on-going contact with outpatient care.
- Have an individual care plan and crisis plan.
- Have had at least one inpatient care period the previous year.
- Are expected to have the greatest need of inpatient care.
- Are interested in, and understand the concept of, patient-controlled admissions.
Who cannot join
- No informed consent to participate in the research project (concerns only self-reported outcomes).
- Matched control group:
- A matched control group consisting of seven times the number of of patients receiving patient-control admissions will be utilised for all primary outcome measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed prescriptions (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Centre for Psychiatry Research
Stockholm, Stockholm County, 113 64
Alexander Rozental, PhD, +46(0)736937948, alexander.rozental@ki.se
Sigrid Salomonsson, PhD, +46(0)722025947, sigrid.salomonsson@ki.se
About this study
Official title: Patient-controlled Admissions to Inpatient Care for Patients With Severe Psychiatric Conditions in Region Stockholm
Patient-controlled admissions refer to the possibility for patients with severe psychiatric conditions to admit themselves to inpatient care. Compared to having the healthcare providers make this decision, patient-controlled admissions are believed to decrease the need for involuntary care, decrease symptom levels, and increase quality of life and autonomy for the patient. The current research project aims to evaluate the implementation of patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry (but excluding forensic psychiatry and addiction care).
Read the detailed description
Patients with severe psychiatric conditions represent a group who have extensive care needs and for whom few effective interventions exist. Diagnoses such as schizophrenia and borderline personality disorder usually have a poor prognostic outlook in terms of recovery, and patients often suffer from life-long disabilities. Meanwhile, their healthcare expenditures are typically high. In case of increased symptoms and novel sickness spells, healthcare providers make an assessment if admission to inpatient care is needed. This gatekeeper-model is typical of most western countries and infers that the decision to be admitted is always made by a third party. Since about a decade, attempts at transferring the responsibility of admissions to patients themselves is being implemented and tested in several countries and contexts, referred to as patient-controlled admissions. The idea is to increase patient involvement, enhance self-determination, and improve their ability to manage signs of illness. Patient-controlled admissions involve signing an agreement between inpatient care, outpatient care, and those patients that are deemed to have the highest care needs, whereby the patients can contact an inpatient ward and be admitted when required. Previous research has revealed that patient-controlled admissions decrease involuntary admissions and that both healthcare providers and patients are positive towards its use. These studies have however been small and used limited outcome measures. The current research project aims to study the results of implementing patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry (but excluding forensic psychiatry and addiction care). Apart from determining the possible impact on both number of admissions and days in admission (voluntary and involuntary), other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions, self-report measures will be used to assess the effects on symptom levels, quality of life, and autonomy. A matched control group (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions) will also be utilised to determine the effects of patient-controlled admissions on all primary outcomes measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions.
- Being tested
- Patient-controlled admissions
- Keywords
- Patient-controlled admissions, Self-referrals, Patient participation, Inpatient care
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled admissionsOther
Patients are allowed to admit themselves to inpatient care when needed (standard procedure, four days of inpatient care at a time, up to three times a month)
| Study group | Role | What they receive |
|---|---|---|
| Patient-controlled admissions | Patients who have been granted access to patient-controlled admissions Receives: Other: Patient-controlled admissions | |
| Matched control group | Patients matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admissions to inpatient care
Number of admissions to inpatient care
Measured: Change in number of admissions to inpatient care between baseline and at 12 months
Days in inpatient care
Number of days in inpatient care
Measured: Change in number of days in inpatient care between baseline and 12 months
Admissions to inpatient care
Number of admissions to inpatient care
Measured: Change in number of admissions to inpatient care between baseline and at 24 months
Days in inpatient care
Number of days in inpatient care
Measured: Change in number of days in inpatient care between baseline and 24 months
Admissions to inpatient care
Number of admissions to inpatient care
Measured: Change in number of admissions to inpatient care between baseline and at 36 months
Days in inpatient care
Number of days in inpatient care
Measured: Change in number of days in inpatient care between baseline and 36 months
Admissions to involuntary care
Number of admissions to involuntary care
Measured: Change in number of admissions to involuntary care between baseline and at 12 months
Days in involuntary care
Number of days in involuntary care
Measured: Change in number of days in involuntary care between baseline and at 12 months
Admissions to involuntary care
Number of admissions to involuntary care
Measured: Change in number of admissions to involuntary care between baseline and at 24 months
Days in involuntary care
Number of days in involuntary care
Measured: Change in number of days in involuntary care between baseline and at 24 months
Admissions to involuntary care
Number of admissions to involuntary care
Measured: Change in number of admissions to involuntary care between baseline and at 36 months
Days in involuntary care
Number of days in involuntary care
Measured: Change in number of days in involuntary care between baseline and at 36 months
Coercive measures
Number of coercive measures (forced medication, seclusion, and restraint)
Measured: Change in number of coercive measures between baseline and at 12 months
Coercive measures
Number of coercive measures (forced medication, seclusion, and restraint)
Measured: Change in number of coercive measures between baseline and at 24 months
Coercive measures
Number of coercive measures (forced medication, seclusion, and restraint)
Measured: Change in number of coercive measures between baseline and at 36 months
Secondary outcomes (11)
EQ5D-5L
Self-rated quality of life (somatic) on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The scores for the five dimensions can be combined into a five-digit number that describes the patient's health state, with 11,111 indicating perfect health and 55,555 the worst health state. The outcome ranges from 5 (no health limitations at all, 11,111) to 25 (for state 55,555).
Measured: Change in self-rated quality of life (somatic) between baseline and at 12 months
World Health Organization Disability Assessment Schedule
Self-rated quality of life (somatic) on six dimensions: cognition, mobility, self-care, getting along with people, life activities and participation - including work-related disability. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5) - are then summed. A higher sum score indicates worse quality of life (100 = full disability; 0 = no disability).
Measured: Change in self-rated quality of life (somatic) between baseline and at 12 months
Clinical Global Impression
Clinician-rated functional level, measuring symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It has two domains, severity scale and Improvement scale. Both are scored on a 7 point scale; 1 = Normal, not at all ill to 7 = Among the most extremely ill patients, as well as 1 = Very much improved, and 7 = Very much worse. A higher score indicates worse functional level and a worsening of functioning, respectively.
Measured: Change in clinician-rated functional level between baseline and at 12 months
Brunnsviken Brief Quality of life scale
Self-rated quality of life (psychological), including 12 items covering six life areas: Leisure, View on life, Creativity, Learning, Friends and Friendship, and View on self. All items are scored using the same response format, con- sisting of a five-step Likert rating scale, visually scored 0-4 with written anchor points at 0 (Strongly disagree) and 4 (Strongly agree). The BBQ total score is computed by summing the weighted satisfaction ratings, i.e. by multiplying the Satisfaction and Importance items for each life area and summing the six products for a total score (possible score range 0-96). A higher sum score indicates a better quality of life.
Measured: Change in self-rated quality of life (psychological) between baseline and at 12 months
General Self-Efficacy scale
Self-rated self-efficacy, assessing a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. The response to 10 items are made on a 4-point scale ( 1 = Not at all true, 2 = Hardly true, 3 = Moderately true. 4 = Exactly true). The sum of all 10 items yield the final composite score with a range from 10 to 40. A higher sum score indicates a higher self-efficacy.
Measured: Change in self-rated self-efficacy between baseline and at 12 months
Generalized Anxiety Disorder - 7 items
Self-rated anxiety, a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder and symptoms of anxiety and worry. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Measured: Change in self-rated anxiety between baseline and at 12 months
The Patient Health Questionnaire - 9 items
Self-rated depression, measures depression using nine items on 4-point scales and a 4-point scale for impact on daily life. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day); 0-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-27 = severe depression.
Measured: Change in self-rated depression between baseline and at 12 months
Visual Analogue Scales
Four items assessing different aspects of the patients' care needs and current health status are administered monthly. These include the following; 1) "I feel confident about receiving care when I need it" 2) "I am able to actively participate in my care", and 3) "I believe care is available when needed". These are scored on a continuum ranging from "I do not agree at all" (0) to "Totally agree" (10). Also, a fourth item concerns "How would you rate your current health status?", which is rated between "Worst possible health" (0) and "Best possible health" (10).
Measured: Change in self-rated care needs and current health status between baseline and at 12 months
Other psychiatric or somatic healthcare consumption
Number of other psychiatric or somatic healthcare consumption
Measured: Change in number of other psychiatric or somatic healthcare consumption between baseline and 12 months
Sick-leave
Number of days in sick-leave
Measured: Change in number of days in sick-leave between baseline and 12 months
Redeemed medical prescriptions
Number of redeemed medical prescriptions
Measured: Change in number of redeemed medical prescriptions between baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jan 2020
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
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 Patient-controlled AdmissionsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 564 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm Health Care Services
- Responsible party
- Principal investigator, Alexander Rozental, Karolinska Institutet
- Investigators
- Alexander Rozental, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862897
- Sponsor's protocol ID
- 2020-06498
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data include patient records and need a permit from Stockholm Health Care Services in order to become available to other researchers.
Publications
Smitmanis Lyle M, Allenius E, Salomonsson S, Bjorkdahl A, Strand M, Flyckt L, Hellner C, Lundgren T, Jayaram-Lindstrom N, Rozental A. What are the effects of implementing patient-controlled admissions in inpatient care? A study protocol of a large-scale implementation and naturalistic evaluation for adult and adolescent patients with severe psychiatric conditions throughout Region Stockholm. BMJ Open. 2022 Aug 16;12(8):e065770. doi: 10.1136/bmjopen-2022-065770.
PubMed 35973700
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Admissions to Inpatient Care for Patients With Severe Psychiatric Conditions in Region Stockholm
- ClinicalTrials.gov ID
- NCT04862897
- Acronym / sponsor ID
- 2020-06498
- Keywords
- Patient-controlled admissions, Self-referrals, Patient participation, Inpatient care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm Health Care Services
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Apr 2021 (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.
Patient-controlled admissions refer to the possibility for patients with severe psychiatric conditions to admit themselves to inpatient care. Compared to having the healthcare providers make this decision, patient-controlled admissions are believed to decrease the need for involuntary care, decrease symptom levels, and increase quality of life and autonomy for the patient. The current research project aims to evaluate the implementation of patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry (but excluding forensic psychiatry and addiction care).
Detailed description
Patients with severe psychiatric conditions represent a group who have extensive care needs and for whom few effective interventions exist. Diagnoses such as schizophrenia and borderline personality disorder usually have a poor prognostic outlook in terms of recovery, and patients often suffer from life-long disabilities. Meanwhile, their healthcare expenditures are typically high. In case of increased symptoms and novel sickness spells, healthcare providers make an assessment if admission to inpatient care is needed. This gatekeeper-model is typical of most western countries and infers that the decision to be admitted is always made by a third party. Since about a decade, attempts at transferring the responsibility of admissions to patients themselves is being implemented and tested in several countries and contexts, referred to as patient-controlled admissions. The idea is to increase patient involvement, enhance self-determination, and improve their ability to manage signs of illness. Patient-controlled admissions involve signing an agreement between inpatient care, outpatient care, and those patients that are deemed to have the highest care needs, whereby the patients can contact an inpatient ward and be admitted when required. Previous research has revealed that patient-controlled admissions decrease involuntary admissions and that both healthcare providers and patients are positive towards its use. These studies have however been small and used limited outcome measures. The current research project aims to study the results of implementing patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry (but excluding forensic psychiatry and addiction care). Apart from determining the possible impact on both number of admissions and days in admission (voluntary and involuntary), other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions, self-report measures will be used to assess the effects on symptom levels, quality of life, and autonomy. A matched control group (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions) will also be utilised to determine the effects of patient-controlled admissions on all primary outcomes measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-controlled admissions | – | Other: Patient-controlled admissionsPatients who have been granted access to patient-controlled admissions |
| Matched control group | – | –Patients matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with severe psychiatric conditions in Region Stockholm who fulfil the inclusion criteria can be provided access to patient-controlled admissions. This includes child and adolescent psychiatry, but excludes forensic psychiatry and addiction care. All patients who receives patient-controlled admissions and a matched control group will be evaluated regarding all primary outcome measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed medical prescriptions. For the remaining secondary outcomes measures (i.e., self-reported outcomes), only those patients who consent to participate in the research project will be evaluated.
Key inclusion criteria (5 listed)
- Have an on-going contact with outpatient care.
- Have an individual care plan and crisis plan.
- Have had at least one inpatient care period the previous year.
- Are expected to have the greatest need of inpatient care.
- Are interested in, and understand the concept of, patient-controlled admissions.
Key exclusion criteria (3 listed)
- No informed consent to participate in the research project (concerns only self-reported outcomes).
- A matched control group consisting of seven times the number of of patients receiving patient-control admissions will be utilised for all primary outcome measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed prescriptions (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions)
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 |
|---|---|---|
| Patient-controlled admissionsPatients are allowed to admit themselves to inpatient care when needed (standard procedure, four days of inpatient care at a time, up to three times a month) | Other | Patient-controlled admissions |
Primary outcome
Admissions to inpatient care
Time frame: Change in number of admissions to inpatient care between baseline and at 12 months
Number of admissions to inpatient care
Days in inpatient care
Time frame: Change in number of days in inpatient care between baseline and 12 months
Number of days in inpatient care
Admissions to inpatient care
Time frame: Change in number of admissions to inpatient care between baseline and at 24 months
Number of admissions to inpatient care
Days in inpatient care
Time frame: Change in number of days in inpatient care between baseline and 24 months
Number of days in inpatient care
Admissions to inpatient care
Time frame: Change in number of admissions to inpatient care between baseline and at 36 months
Number of admissions to inpatient care
Days in inpatient care
Time frame: Change in number of days in inpatient care between baseline and 36 months
Number of days in inpatient care
Admissions to involuntary care
Time frame: Change in number of admissions to involuntary care between baseline and at 12 months
Number of admissions to involuntary care
Days in involuntary care
Time frame: Change in number of days in involuntary care between baseline and at 12 months
Number of days in involuntary care
Admissions to involuntary care
Time frame: Change in number of admissions to involuntary care between baseline and at 24 months
Number of admissions to involuntary care
Days in involuntary care
Time frame: Change in number of days in involuntary care between baseline and at 24 months
Number of days in involuntary care
Admissions to involuntary care
Time frame: Change in number of admissions to involuntary care between baseline and at 36 months
Number of admissions to involuntary care
Days in involuntary care
Time frame: Change in number of days in involuntary care between baseline and at 36 months
Number of days in involuntary care
Coercive measures
Time frame: Change in number of coercive measures between baseline and at 12 months
Number of coercive measures (forced medication, seclusion, and restraint)
Coercive measures
Time frame: Change in number of coercive measures between baseline and at 24 months
Number of coercive measures (forced medication, seclusion, and restraint)
Coercive measures
Time frame: Change in number of coercive measures between baseline and at 36 months
Number of coercive measures (forced medication, seclusion, and restraint)
11 secondary outcomes
EQ5D-5L
Time frame: Change in self-rated quality of life (somatic) between baseline and at 12 months
World Health Organization Disability Assessment Schedule
Time frame: Change in self-rated quality of life (somatic) between baseline and at 12 months
Clinical Global Impression
Time frame: Change in clinician-rated functional level between baseline and at 12 months
Brunnsviken Brief Quality of life scale
Time frame: Change in self-rated quality of life (psychological) between baseline and at 12 months
General Self-Efficacy scale
Time frame: Change in self-rated self-efficacy between baseline and at 12 months
Generalized Anxiety Disorder - 7 items
Time frame: Change in self-rated anxiety between baseline and at 12 months
The Patient Health Questionnaire - 9 items
Time frame: Change in self-rated depression between baseline and at 12 months
Visual Analogue Scales
Time frame: Change in self-rated care needs and current health status between baseline and at 12 months
Other psychiatric or somatic healthcare consumption
Time frame: Change in number of other psychiatric or somatic healthcare consumption between baseline and 12 months
Sick-leave
Time frame: Change in number of days in sick-leave between baseline and 12 months
Redeemed medical prescriptions
Time frame: Change in number of redeemed medical prescriptions between baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publication: PubMed 35973700Smitmanis Lyle M, Allenius E, Salomonsson S, Bjorkdahl A, Strand M, Flyckt L, Hellner C, Lundgren T, Jayaram-Lindstrom N, Rozental A. What are the effects of implementing patient-controlled admissions in inpatient care? A study protocol of a large-scale implementation and naturalistic evaluation for adult and adolescent patients with severe psychiatric conditions throughout Region Stockholm. BMJ Open. 2022 Aug 16;12(8):e065770. doi: 10.1136/bmjopen-2022-065770.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data include patient records and need a permit from Stockholm Health Care Services in order to become available to other researchers.
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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.
Alexander Rozental, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient-controlled Admissions and Matched Control Group, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Rozental, PhD (+46(0)736937948, alexander.rozental@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admissions to inpatient care (time frame: Change in number of admissions to inpatient care between baseline and at 12 months). The study lists 15 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 NCT04862897, 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 16 Sep 2025.