Caregiver BurdenNCT06190262
Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness
A study testing The intervention is community based group psychoeducation in people with Caregiver Burden and Caregiver Burnout, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The goal of this one-arm pre-test/post-test study is to evaluate the feasibility and preliminary effect of a community-based psychoeducational group intervention for informal caregivers of individuals with mental illness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Caregiver Burnout, Well-Being, Psychological
- What is being tested?
- The intervention is community based group psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Jan 2024to 30 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to read, speak, and understand the Danish langugage
- Relative/informal caregiver of an individual with a mental illness
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness: A Feasibility Study
The goal of this one-arm pre-test/post-test study is to evaluate the feasibility and preliminary effect of a community-based psychoeducational group intervention for informal caregivers of individuals with mental illness.
The main questions it aims to answer are:
Read more
- What is the feasibility and acceptability of the intervention?
- What is the preliminary effect of the intervention?
Participants self-select to the intervention and participation in the evaluation is voluntary. Participants will be asked to:
- Answer a questionnaire before and after their participation
- Some participants will be invited for an in-depth interview
There is no comparison group, but feasibility and acceptability will also be explored by asking the implementation team (e.g. project leaders and teachers) to participate in:
- In-depth interviews
- Answering shorter questionnaires about provider acceptability
Read the detailed description
The program/intervention:
The group-based psychoeducational program focuses on enhancing informal caregivers' or relatives' understanding of their loved ones' mental illnesses and equips them with coping strategies. The main goal is to improve caregivers' knowledge of mental illnesses and their ability to navigate in their daily life/their role as an informal caregiver without becoming overburdened.
The specific program was collaboratively developed by a non-government organization and the regional psychiatry in one of Denmarks five Regions. Participants self-select to the program and participation is free of cost.
The program consists of six sessions, two of which are conducted online. The program is designed for groups of 16-20 individuals.
Session 1: The first session serves as an introduction to the program, where participants get acquainted with each other and familiarize themselves with the program's content. During this session, participants are encouraged to establish their own rules while also discussing the "Chatham House rules."
Session 2: Moving on to the second session, the focus is on disseminating knowledge about mental illnesses, treatment, and the distinctions between regional psychiatry and community-based treatments. A compassion-focused exercise is also included during this session.
Session 3: The third session centers on providing information about various treatment opportunities, exploring different types of treatment in addition to medication and talk therapy. Moreover, participants gain insights into how they can be involved in the treatment process if the patient provides their consent. This session is conducted online.
Session 4: The fourth session delves into the caregiver role and self-care strategies. Participants are introduced to different coping-strategies.
Session 5: In the fifth session, the focus shifts to the rights of the participants, such as their entitlement to care days and information about other caregiver interventions in the community. This session is conducted online.
Session 6: Finally, in the last session, all the topics covered throughout the program are summarized, and support groups are established to provide ongoing assistance and encouragement.
In 2024, around 24 courses will be offered, each spanning a duration of 35-70 days. The sessions will be conducted. The sessions will be scheduled either weekly (with 6 sessions over a 35-day period) or bi-weekly (with 6 sessions over a 70-day period).
The evaluation:
All participants in the program will be asked to participate in the evaluation. Participation in the evaluation is completely voluntary.
The primary purpose of the evaluation is to use the results of the evaluation to continuously revise the program to reflect the needs of the participants. By the end of 2025, the program will have undergone the last revision, and be ready to move on to a full evaluation using a RCT design. Thus, in line with guidance from the UK Medical Council Research Framework (MRC) and the National Institute of Health Research framework, the present study is an initial step in determining if the developed intervention is feasible and acceptable for relatives to individuals with mental illness. A mixed-methods approach was chosen to explore indications of participants' response and view to the intervention and thereby gain a more full understanding of the intervention acceptability and feasibility.
The principal aims of this study are as follows:
- To assess the feasibility and acceptability of the intervention, the investigators aim to:
- Quantify recruitment rate and attendance rate
- Measure participants' satisfaction with the intervention
- Qualitatively explore participants satisfaction and their ideas for development
- By using purposeful sampling strategies, some participants will be invited to take part in an in-depth interview about their experience with the program and about their perspective on facilitators and barriers of the intervention. They will also be asked about how to improve the program in the future.
- To assess the preliminary effectiveness of the intervention, participants are asked to:
- Self-report on their well-being before and after the intervention
- Self-report on their level of burnout before and after the intervention
- Self-report on their level of resilient coping before and after the intervention This evidence will provide an initial indication of whether the intervention can contribute to change within this group. Estimated effect sizes will provide the parameters for a definitive randomized controlled trial. Data will be explored using the reliable and clinically significant change analysis. This analysis allows pre- and post-treatment scores to be compared to see if participants have achieved a level of difference that could be categorized as real and not due to measurement error. Furthermore this score can be helpful to determine if the change seen is clinically significant.
- To assess feasibility and acceptability from the providers, the investigators aim to:
- Conduct in-depth interviews with members of the implementation teams (such as project leaders and teachers in the program).
- Conditions
- Caregiver Burden, Caregiver Burnout, Well-Being, Psychological, Coping Strategies, Knowledge, Attitudes, Practice
- Being tested
- The intervention is community based group psychoeducation
- Medical subject headings
- Caregiver Burden, Psychological Well-Being, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention is community based group psychoeducationBehavioural
The intervention is community based group psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | The experimental condition consists of a psychoeducation program with six sessions. Two of the sessions are online. A teacher and a volunteer will lead the sessions. The topic of the sessions are diverse and cover topics such as mental illness, the diathesis-stress model, treatment of mental illness, caregiver coping mechanisms and caregiver rights.
Before the first session, participants are asked to fill in an online questionnaire with background information and well-being indicators. After the last session, participants are asked to fill in another short questionnaire with the same well-being indicators and also a measure of their satisfaction with the program. Receives: Behavioral: The intervention is community based group psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
To measure the feasibility of the intervention, there is a measure of recruitment rate (number of participants recruited/time period in months).
Measured: Recruitment rate is monitored throughout the study period (1 year)
Attendance rate
To measure feasibility of the intervention, there is a measure of attendance rate: (number of participants attending/total number of enrolled participants) * 100
Measured: Attendance rates are monitored throughout the study period (1 year)
Retention rate
To measure feasibility of the intervention, there is a measure of retention rate: (number of participants remaining/intital Number of Enrolled Participants) * 100
Measured: Retention rates are monitored throughout the study period (1 year)
Satisfaction, quantitative measure
To measure acceptability of the intervention, participants' overall satisfaction with the program will be measured. This measure is based on 11 questions, that are rated on a 4-point Likert-Scale. Higher scores indicate higher satisfaction.
Measured: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Satisfaction, qualitative measure
To measure acceptability of the intervention, participants are invited to write about their experience with the program and their ideas for program development.
Measured: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Suitability, qualitative measure
Based on individual semi-structured interviews with some of the participants the investigators will evaluate whether the intervention fits the target population's needs, preferences, and cultural context. This measure will be used to assess whether any modifactions are needed to enhance the programme suitability.
Measured: Individual semi-structured interviews will be conducted throughout the study period (1 year).
Barriers and facilitators, qualitative measure (provider perspective)
Based on focus-group interviews with the teachers and other stakeholders, qualitative data will be collected to understand the providers' experiences, perceptions, and suggestions for improvement of the program.
Measured: Focus-group interviews will be conducted throughout the study period (1 year).
Secondary outcomes (3)
Well-being: WHO-5 well-being index
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. It is composed of five questions that are rated on a 6-point Likert-Scale, where 5 = all the time and 0 = at no time. The raw score ranging from 0 to 25 is multiplied by 4 to give the final score from 0 (representing the worst imaginable well-being) to 100 (representing the best imaginable well-being).
Measured: 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Personal Burnout: Copenhagen Burnout Inventory (CBI; personal burnout)
The CBI consists of three inventories measuring 1) personal burnout, 2) work-related burnout, and 3) client-related burnout, for use in different domains. In this study, only the personal burnout inventory is used. The personal burnout inventory consists of six questions that are rated on a 5-point Likert-Scale ranging from 1 (never/almost never), 2 (seldom), 3 (sometimes), 4 (often), and 5 (always).
Total score on the scale is the average of the scores on the items, and higher scores indicate higher levels of burnout.
Measured: 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Coping: Brief resilient coping scale
The Brief Resilient Coping Scale captures tendencies to cope with stress adaptively. The scale focuses on the tendency to effectively use coping strategies in flexible, committed ways to actively solve problems despite stressful circumstances. The four items are rated on a 5-point Likert-Scale ranging from 1 (does not describe me at all) to 5 (describes me very well). Higher scores indicate more resilient coping. The score ranges from 4 - 20. Scores from 4-13 represent low resilient copers; scores from 14-16 represent medium resilient copers; and scores from 17-20 represent high resilient copers.
Measured: 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start8 Jan 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One arm pre-test/post-test design.
- Masking
- None (open label)
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Odense Patient Data Explorative Network
- Responsible party
- Sponsor
- Investigators
- Rikke Amalie Agergaard Jensen, Ph.d., Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190262
- Sponsor's protocol ID
- OP_1919
- Other IDs
- S-20232000 - 66, 23/25502, 23/70733
- Status last verified
- Mar 2025
- First submitted
- 28 Jul 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analysed during the current study are not expected to be made available due to sensitive information.
Publications
Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144.
PubMed 14994958Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.
PubMed 18179329Morley S, Williams A, Hussain S. Estimating the clinical effectiveness of cognitive behavioural therapy in the clinic: evaluation of a CBT informed pain management programme. Pain. 2008 Jul 31;137(3):670-680. doi: 10.1016/j.pain.2008.02.025. Epub 2008 Apr 3.
PubMed 18394806
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06190262
- Acronym / sponsor ID
- OP_1919
- Conditions
- Caregiver Burden, Caregiver Burnout, Well-Being, Psychological, Coping Strategies, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Odense Patient Data Explorative Network
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 5 Jan 2024 (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 goal of this one-arm pre-test/post-test study is to evaluate the feasibility and preliminary effect of a community-based psychoeducational group intervention for informal caregivers of individuals with mental illness.
The main questions it aims to answer are:
- What is the feasibility and acceptability of the intervention?
- What is the preliminary effect of the intervention?
Participants self-select to the intervention and participation in the evaluation is voluntary. Participants will be asked to:
- Answer a questionnaire before and after their participation
- Some participants will be invited for an in-depth interview
There is no comparison group, but feasibility and acceptability will also be explored by asking the implementation team (e.g. project leaders and teachers) to participate in:
- In-depth interviews
- Answering shorter questionnaires about provider acceptability
Detailed description
The program/intervention:
The group-based psychoeducational program focuses on enhancing informal caregivers' or relatives' understanding of their loved ones' mental illnesses and equips them with coping strategies. The main goal is to improve caregivers' knowledge of mental illnesses and their ability to navigate in their daily life/their role as an informal caregiver without becoming overburdened.
The specific program was collaboratively developed by a non-government organization and the regional psychiatry in one of Denmarks five Regions. Participants self-select to the program and participation is free of cost.
The program consists of six sessions, two of which are conducted online. The program is designed for groups of 16-20 individuals.
Session 1: The first session serves as an introduction to the program, where participants get acquainted with each other and familiarize themselves with the program's content. During this session, participants are encouraged to establish their own rules while also discussing the "Chatham House rules."
Session 2: Moving on to the second session, the focus is on disseminating knowledge about mental illnesses, treatment, and the distinctions between regional psychiatry and community-based treatments. A compassion-focused exercise is also included during this session.
Session 3: The third session centers on providing information about various treatment opportunities, exploring different types of treatment in addition to medication and talk therapy. Moreover, participants gain insights into how they can be involved in the treatment process if the patient provides their consent. This session is conducted online.
Session 4: The fourth session delves into the caregiver role and self-care strategies. Participants are introduced to different coping-strategies.
Session 5: In the fifth session, the focus shifts to the rights of the participants, such as their entitlement to care days and information about other caregiver interventions in the community. This session is conducted online.
Session 6: Finally, in the last session, all the topics covered throughout the program are summarized, and support groups are established to provide ongoing assistance and encouragement.
In 2024, around 24 courses will be offered, each spanning a duration of 35-70 days. The sessions will be conducted. The sessions will be scheduled either weekly (with 6 sessions over a 35-day period) or bi-weekly (with 6 sessions over a 70-day period).
The evaluation:
All participants in the program will be asked to participate in the evaluation. Participation in the evaluation is completely voluntary.
The primary purpose of the evaluation is to use the results of the evaluation to continuously revise the program to reflect the needs of the participants. By the end of 2025, the program will have undergone the last revision, and be ready to move on to a full evaluation using a RCT design. Thus, in line with guidance from the UK Medical Council Research Framework (MRC) and the National Institute of Health Research framework, the present study is an initial step in determining if the developed intervention is feasible and acceptable for relatives to individuals with mental illness. A mixed-methods approach was chosen to explore indications of participants' response and view to the intervention and thereby gain a more full understanding of the intervention acceptability and feasibility.
The principal aims of this study are as follows:
- To assess the feasibility and acceptability of the intervention, the investigators aim to:
- Quantify recruitment rate and attendance rate
- Measure participants' satisfaction with the intervention
- Qualitatively explore participants satisfaction and their ideas for development
- By using purposeful sampling strategies, some participants will be invited to take part in an in-depth interview about their experience with the program and about their perspective on facilitators and barriers of the intervention. They will also be asked about how to improve the program in the future.
- To assess the preliminary effectiveness of the intervention, participants are asked to:
- Self-report on their well-being before and after the intervention
- Self-report on their level of burnout before and after the intervention
- Self-report on their level of resilient coping before and after the intervention This evidence will provide an initial indication of whether the intervention can contribute to change within this group. Estimated effect sizes will provide the parameters for a definitive randomized controlled trial. Data will be explored using the reliable and clinically significant change analysis. This analysis allows pre- and post-treatment scores to be compared to see if participants have achieved a level of difference that could be categorized as real and not due to measurement error. Furthermore this score can be helpful to determine if the change seen is clinically significant.
- To assess feasibility and acceptability from the providers, the investigators aim to:
- Conduct in-depth interviews with members of the implementation teams (such as project leaders and teachers in the program).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm pre-test/post-test design.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: The intervention is community based group psychoeducationThe experimental condition consists of a psychoeducation program with six sessions. Two of the sessions are online. A teacher and a volunteer will lead the sessions. The topic of the sessions are diverse and cover topics such as mental illness, the diathesis-stress model, treatment of mental illness, caregiver coping mechanisms and caregiver rights. Before the first session, participants are asked to fill in an online questionnaire with background information and well-being indicators. After the last session, participants are asked to fill in another short questionnaire with the same well-being indicators and also a measure of their satisfaction with the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Able to read, speak, and understand the Danish langugage
- Relative/informal caregiver of an individual with a mental illness
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The intervention is community based group psychoeducationThe intervention is community based group psychoeducation | Behavioural | Psychoeducation |
Primary outcome
Recruitment rate
Time frame: Recruitment rate is monitored throughout the study period (1 year)
To measure the feasibility of the intervention, there is a measure of recruitment rate (number of participants recruited/time period in months).
Attendance rate
Time frame: Attendance rates are monitored throughout the study period (1 year)
To measure feasibility of the intervention, there is a measure of attendance rate: (number of participants attending/total number of enrolled participants) * 100
Retention rate
Time frame: Retention rates are monitored throughout the study period (1 year)
To measure feasibility of the intervention, there is a measure of retention rate: (number of participants remaining/intital Number of Enrolled Participants) * 100
Satisfaction, quantitative measure
Time frame: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
To measure acceptability of the intervention, participants' overall satisfaction with the program will be measured. This measure is based on 11 questions, that are rated on a 4-point Likert-Scale. Higher scores indicate higher satisfaction.
Satisfaction, qualitative measure
Time frame: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
To measure acceptability of the intervention, participants are invited to write about their experience with the program and their ideas for program development.
Suitability, qualitative measure
Time frame: Individual semi-structured interviews will be conducted throughout the study period (1 year).
Based on individual semi-structured interviews with some of the participants the investigators will evaluate whether the intervention fits the target population's needs, preferences, and cultural context. This measure will be used to assess whether any modifactions are needed to enhance the programme suitability.
Barriers and facilitators, qualitative measure (provider perspective)
Time frame: Focus-group interviews will be conducted throughout the study period (1 year).
Based on focus-group interviews with the teachers and other stakeholders, qualitative data will be collected to understand the providers' experiences, perceptions, and suggestions for improvement of the program.
3 secondary outcomes
Well-being: WHO-5 well-being index
Time frame: 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Personal Burnout: Copenhagen Burnout Inventory (CBI; personal burnout)
Time frame: 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).
Coping: Brief resilient coping scale
Time frame: 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).
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 28 Mar 2025.
- Background: PubMed 14994958Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 18179329Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.
- Background: PubMed 18394806Morley S, Williams A, Hussain S. Estimating the clinical effectiveness of cognitive behavioural therapy in the clinic: evaluation of a CBT informed pain management programme. Pain. 2008 Jul 31;137(3):670-680. doi: 10.1016/j.pain.2008.02.025. Epub 2008 Apr 3.
- Individual participant dataSharing planned: No. The datasets generated during and/or analysed during the current study are not expected to be made available due to sensitive information.
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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. This study is not recruiting at the moment.
Rikke Amalie Agergaard Jensen, Ph.d. principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention is community based group psychoeducation in people with Caregiver Burden and Caregiver Burnout, run by University of Southern Denmark at 1 site in Denmark.
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 0 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 28 Mar 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 Denmark. 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?
Recruitment rate (time frame: Recruitment rate is monitored throughout the study period (1 year)). The study lists 7 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 NCT06190262, which also lists 4 linked publications.
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 28 Mar 2025.