Rheumatic ArthritisINSPIRENCT07442773
Intervention to Support Partners and Informal Caregivers of Frail RA-patients
A study testing Caregiver support in people with Rheumatic Arthritis, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Background Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with pain, fatigue, functional limitations, and reduced quality of life. As more people live to older age with RA, age-related vulnerability such as frailty becomes increasingly relevant and may amplify functional decline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Arthritis
- What is being tested?
- Caregiver support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2026to 1 Dec 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informal (unpaid) caregiver of an older adult with confirmed rheumatoid arthritis (RA)
- Aged ≥ 18 years
- Care recipient aged ≥ 65 years
- Able to provide informed consent
- Able to complete study questionnaires
- Reports at least moderate caregiver burden, defined as mean CBS score > 1.99 at screening (Caregiver Burden Scale)
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- Aged ≥ 65 years
- Confirmed diagnosis of RA
- Meets frailty eligibility in routine care, defined as Clinical Frailty Scale (CFS) ≥ 5
Who cannot join
- Severe cognitive impairment preventing participation
- Acute mental health crisis
- Other circumstances making it impracticable to complete the intervention and follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Signe Abild, Master of Science contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, Center for Rheummatology and Spine Diseases
Glostrup Municipality, Capital Region, 2600
Luise Lindgren, Ph.D., 22509390 ext. 0045, luise.holberg.lindgren@regionh.dk
Signe Abild, Master of Science, signe.marie.abild@regionh.dk
About this study
Official title: Protocol for the Feasibility Study of INSPIRE: an Individually Tailored Support Intervention for Informal Caregivers of Older Adults With Rheumatoid Arthritis and Frailty
Background Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with pain, fatigue, functional limitations, and reduced quality of life. As more people live to older age with RA, age-related vulnerability such as frailty becomes increasingly relevant and may amplify functional decline, multimorbidity, and reliance on others. Informal caregivers (unpaid family members, friends, or neighbors) often provide substantial practical, emotional, and coordination support, yet caregiver needs are frequently overlooked in rheumatology care. INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) is an individually tailored support intervention developed using the UK Medical Research Council framework for complex interventions and an iterative co-creation process involving older adults with RA and frailty, caregivers, healthcare professionals, and social care stakeholders. Before a definitive evaluation, feasibility and acceptability in routine care must be established.
Aim To evaluate the feasibility and acceptability of delivering INSPIRE in routine rheumatology care and to test study procedures in preparation for a future definitive trial.
Read more
Methods This is a single-arm feasibility study recruiting 25 informal caregivers of older adults with RA and frailty. Recruitment will occur within a fixed four-month window (1 March-1 July 2026) and will not be extended. Care recipients (older adults) will be ≥65 years with RA and frailty classified as Clinical Frailty Scale (CFS) 4-7. Caregivers will be ≥18 years, provide unpaid support, and report at least moderate burden defined as a Caregiver Burden Scale (CBS) mean score >1.99 at screening. Participants will be recruited from Rigshospitalet (Center for Rheumatology and Spine Diseases) and rheumatology departments in Køge, Slagelse, and Holbæk. Identification uses routine patient-reported outcomes (DANBIO) with invitation of potentially frail patients (e.g., MDHAQ >1.0) followed by telephone screening and CFS assessment; eligible patients nominate a caregiver who is then screened using CBS.
Intervention INSPIRE is delivered by a trained healthcare professional over ~12 weeks and comprises three contacts: an initial consultation (60-90 min), a brief follow-up (15-30 min), and a final consultation (30-60 min). Content is tailored using a toolbox addressing validation of the caregiver role, emotional/practical support, education, communication, and navigation across health and municipal services. Involvement of the older adult in consultations is optional and based on preferences of both parties.
Outcomes Feasibility outcomes include recruitment (screened/eligible/consented), retention at 12 weeks, questionnaire completeness, and deliverability (session completion, mode, duration). Acceptability will be assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief acceptability/feasibility questions and qualitative interviews. Fidelity and tailoring will be documented using structured session notes. Exploratory outcomes include caregiver burden measured by Caregiver burden scale, quality of life measured by WHOQOL-BREF (caregiver and older adult), and physical function measured by MDHAQ .
Progression criteria Pre-specified criteria include approximately 50% recruitment of those approached, ≥85% retention, and high fidelity, reviewed using a trafficlight approach (go/amend/stop).
Ethics and dissemination Written informed consent will be obtained from both the older adult and the caregiver prior to baseline data collection, with separate consent for any study components each participant takes part in (e.g., consultations, interviews). Findings will be disseminated through peer-reviewed publication, conferences, and stakeholder summaries.
Read the detailed description
This study evaluates the feasibility and acceptability of delivering INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) within routine rheumatology care and tests study procedures to inform a future definitive trial. INSPIRE is an individually tailored support intervention for informal caregivers of older adults with rheumatoid arthritis (RA) and frailty, developed through stakeholder co-creation and designed for implementation in standard outpatient workflows.
Potentially eligible care recipients are identified using routine patient-reported outcomes completed prior to clinic visits (DANBIO). Functional limitation scores (MDHAQ) are used as a pragmatic trigger for further screening. Interested patients are contacted for telephone screening including frailty classification using the Clinical Frailty Scale (CFS). When an eligible patient agrees, they nominate an informal caregiver who is contacted by the study team, provided study information, and screened for caregiver burden using the Caregiver Burden Scale (CBS). Recruitment occurs within a fixed, pre-specified recruitment period.
INSPIRE is delivered by trained healthcare professionals with rheumatology context and experience in psychosocial support and service navigation. The intervention is delivered over approximately 12 weeks and consists of three structured contacts: (1) an initial consultation (about 60-90 minutes), (2) a brief follow-up contact (about 15-30 minutes; typically telephone), and (3) a final consultation (about 30-60 minutes). Delivery mode is flexible (clinic, home, or telephone) to reflect real-world implementation.
The initial consultation follows a structured needs assessment guided by the caregiver's CBS profile and a semi-structured consultation framework to identify the caregiver's priority burden domains. The healthcare professional supports goal setting and action planning and selects relevant elements from a predefined INSPIRE toolbox. Toolbox elements may include validation of the caregiver role; psychoeducation and coping support; practical strategies to reduce day-to-day strain; communication support within the dyad and with services; RA- and frailty-relevant information; and navigation/signposting to health and municipal services (e.g., home care, assistive devices, respite options, social work pathways). The brief follow-up contact reviews progress, identifies barriers, and adjusts the action plan and toolbox elements as needed. The final consultation consolidates strategies used, reviews ongoing support needs, and supports planning for continued access to relevant services. The older adult with RA may optionally participate in selected consultations when preferred by both parties; the caregiver remains the primary intervention recipient.
Feasibility is assessed using descriptive metrics including screening and recruitment flow, retention through follow-up, completeness of questionnaire data, and intervention deliverability (sessions completed, timing, duration, and mode). Acceptability is assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief structured questions and qualitative interviews with caregivers (and optionally older adults and/or delivering professionals) to explore perceived usefulness and implementation barriers and facilitators. Intervention fidelity and tailoring are documented using structured session notes recording components delivered, toolbox elements selected, caregiver goals, and referrals/signposting.
Analyses are descriptive and focus on feasibility and process outcomes. Candidate outcome measures are summarized at baseline and follow-up to assess completeness and variability; exploratory pre-post changes may be presented without formal hypothesis testing. The intervention is considered low risk; discussions may elicit emotional discomfort, and participants may pause or discontinue at any time. Delivering professionals follow predefined signposting/referral pathways if significant distress is identified. Data are managed securely and reported in anonymized form in accordance with applicable data protection requirements.
- Conditions
- Rheumatic Arthritis
- Being tested
- Caregiver support
- Keywords
- Frailty, RA, older adults, caregivers, support
- Medical subject headings
- Rheumatic Fever, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver supportBehavioural
Intervention: INSPIRE INSPIRE is delivered by a trained healthcare professional with rheumatology expertise and experience in psychosocial support and service navigation. The intervention runs over approximately twelve weeks and includes an initial consultation, follow-up, and a final consultation. The initial consultation (about 60-90 minutes) takes place at home or in the clinic and is guided by the caregiver's CBS pro-file. It focuses on recognizing and validating the caregiver role, identifying the most burdensome is-sues, exploring underlying causes, and establishing realistic goals. Based on the needs identified, the caregiver is introduced to a tailored toolbox of resources and referral pathways that may include emotional or psychological support options, guidance on managing practical and physical strain, support for social isolation, communication and relationship support, disease-related education, and assistance navigating municipal and health system services.
| Study group | Role | What they receive |
|---|---|---|
| Support intervention | Experimental | Participants will receive the INSPIRE intervention Receives: Behavioral: Caregiver support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate will be assessed as the number of caregivers recruited out of the number of eligible caregivers
Measured: 3 months
Retention rate
Retention rate will be assessed as the number of participants who withdrew from the study out of the total number of participants.
Measured: 3 months
Intervention deliverability
Number of sessions completed
Measured: 3 months
Intervention deliverability
Session duration
Measured: 3 months
Intervention deliverability
Session mode
Measured: 3 months
Secondary outcomes (6)
Fidelity
Intervention fidelity is estimated based on documentation sheets, filled out after each session by the healthcare professional delivering the intervention
Measured: 3 months
Data completeness
Missing data will be assessed as the number of items answered relative to the total number of items (i.e., item-level completeness)
Measured: 3 months
Acceptability
Acceptability will be assessed using post-intervention acceptability questions
Measured: 3 months
Caregiver burden
The Caregiver Burden Scale (CBS) is a 22-item self-report questionnaire covering five domains (general strain, isolation, disappointment, emotional involvement, and environment). Each item is rated on a 4-point response scale from 1 to 4, yielding a mean total score ranging from 1 (minimum) to 4 (maximum). Higher scores indicate worse outcome (greater perceived caregiver burden).
Measured: Baseline and 3 months
Health related quality of life
Quality of life will be measured using the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF). The WHOQOL-BREF is a 26-item, generic quality-of-life instrument covering four domains (physical, psychological, social relationships, and environment) plus two overall items (overall QoL and general health).
Each item is rated on a 5-point Likert scale with values ranging from 1 to 5 (minimum = 1; maximum = 5). Higher scores indicate better quality of life / better perceived health. Domain scores are typically calculated by summing relevant items and transforming to a standardized scale; regardless of transformation, higher domain scores represent better quality of life.
Measured: Baseline and 3 months
Physical function
Physical function will be assessed using the physical function section of the Multidimensional Health Assessment Questionnaire (MDHAQ). The physical function section (often reported as the MDHAQ Function score) is typically scored from 0 to 3 (minimum = 0; maximum = 3), where higher scores indicate worse physical function (greater disability/limitations).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic ArthritisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bente Appel Esbensen, Glostrup University Hospital, Copenhagen
- Investigators
- Bente Esbensen, Professor, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442773
- Sponsor's protocol ID
- GlostrupUHNinspire
- Acronym
- INSPIRE
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Feasibility Study of INSPIRE: an Individually Tailored Support Intervention for Informal Caregivers of Older Adults With Rheumatoid Arthritis and Frailty
- ClinicalTrials.gov ID
- NCT07442773
- Acronym / sponsor ID
- INSPIRE / GlostrupUHNinspire
- Conditions
- Rheumatic Arthritis
- Keywords
- Frailty, RA, older adults, caregivers, support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Mar 2026 (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.
Background Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with pain, fatigue, functional limitations, and reduced quality of life. As more people live to older age with RA, age-related vulnerability such as frailty becomes increasingly relevant and may amplify functional decline, multimorbidity, and reliance on others. Informal caregivers (unpaid family members, friends, or neighbors) often provide substantial practical, emotional, and coordination support, yet caregiver needs are frequently overlooked in rheumatology care. INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) is an individually tailored support intervention developed using the UK Medical Research Council framework for complex interventions and an iterative co-creation process involving older adults with RA and frailty, caregivers, healthcare professionals, and social care stakeholders. Before a definitive evaluation, feasibility and acceptability in routine care must be established.
Aim To evaluate the feasibility and acceptability of delivering INSPIRE in routine rheumatology care and to test study procedures in preparation for a future definitive trial.
Methods This is a single-arm feasibility study recruiting 25 informal caregivers of older adults with RA and frailty. Recruitment will occur within a fixed four-month window (1 March-1 July 2026) and will not be extended. Care recipients (older adults) will be ≥65 years with RA and frailty classified as Clinical Frailty Scale (CFS) 4-7. Caregivers will be ≥18 years, provide unpaid support, and report at least moderate burden defined as a Caregiver Burden Scale (CBS) mean score >1.99 at screening. Participants will be recruited from Rigshospitalet (Center for Rheumatology and Spine Diseases) and rheumatology departments in Køge, Slagelse, and Holbæk. Identification uses routine patient-reported outcomes (DANBIO) with invitation of potentially frail patients (e.g., MDHAQ >1.0) followed by telephone screening and CFS assessment; eligible patients nominate a caregiver who is then screened using CBS.
Intervention INSPIRE is delivered by a trained healthcare professional over ~12 weeks and comprises three contacts: an initial consultation (60-90 min), a brief follow-up (15-30 min), and a final consultation (30-60 min). Content is tailored using a toolbox addressing validation of the caregiver role, emotional/practical support, education, communication, and navigation across health and municipal services. Involvement of the older adult in consultations is optional and based on preferences of both parties.
Outcomes Feasibility outcomes include recruitment (screened/eligible/consented), retention at 12 weeks, questionnaire completeness, and deliverability (session completion, mode, duration). Acceptability will be assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief acceptability/feasibility questions and qualitative interviews. Fidelity and tailoring will be documented using structured session notes. Exploratory outcomes include caregiver burden measured by Caregiver burden scale, quality of life measured by WHOQOL-BREF (caregiver and older adult), and physical function measured by MDHAQ .
Progression criteria Pre-specified criteria include approximately 50% recruitment of those approached, ≥85% retention, and high fidelity, reviewed using a trafficlight approach (go/amend/stop).
Ethics and dissemination Written informed consent will be obtained from both the older adult and the caregiver prior to baseline data collection, with separate consent for any study components each participant takes part in (e.g., consultations, interviews). Findings will be disseminated through peer-reviewed publication, conferences, and stakeholder summaries.
Detailed description
This study evaluates the feasibility and acceptability of delivering INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) within routine rheumatology care and tests study procedures to inform a future definitive trial. INSPIRE is an individually tailored support intervention for informal caregivers of older adults with rheumatoid arthritis (RA) and frailty, developed through stakeholder co-creation and designed for implementation in standard outpatient workflows.
Potentially eligible care recipients are identified using routine patient-reported outcomes completed prior to clinic visits (DANBIO). Functional limitation scores (MDHAQ) are used as a pragmatic trigger for further screening. Interested patients are contacted for telephone screening including frailty classification using the Clinical Frailty Scale (CFS). When an eligible patient agrees, they nominate an informal caregiver who is contacted by the study team, provided study information, and screened for caregiver burden using the Caregiver Burden Scale (CBS). Recruitment occurs within a fixed, pre-specified recruitment period.
INSPIRE is delivered by trained healthcare professionals with rheumatology context and experience in psychosocial support and service navigation. The intervention is delivered over approximately 12 weeks and consists of three structured contacts: (1) an initial consultation (about 60-90 minutes), (2) a brief follow-up contact (about 15-30 minutes; typically telephone), and (3) a final consultation (about 30-60 minutes). Delivery mode is flexible (clinic, home, or telephone) to reflect real-world implementation.
The initial consultation follows a structured needs assessment guided by the caregiver's CBS profile and a semi-structured consultation framework to identify the caregiver's priority burden domains. The healthcare professional supports goal setting and action planning and selects relevant elements from a predefined INSPIRE toolbox. Toolbox elements may include validation of the caregiver role; psychoeducation and coping support; practical strategies to reduce day-to-day strain; communication support within the dyad and with services; RA- and frailty-relevant information; and navigation/signposting to health and municipal services (e.g., home care, assistive devices, respite options, social work pathways). The brief follow-up contact reviews progress, identifies barriers, and adjusts the action plan and toolbox elements as needed. The final consultation consolidates strategies used, reviews ongoing support needs, and supports planning for continued access to relevant services. The older adult with RA may optionally participate in selected consultations when preferred by both parties; the caregiver remains the primary intervention recipient.
Feasibility is assessed using descriptive metrics including screening and recruitment flow, retention through follow-up, completeness of questionnaire data, and intervention deliverability (sessions completed, timing, duration, and mode). Acceptability is assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief structured questions and qualitative interviews with caregivers (and optionally older adults and/or delivering professionals) to explore perceived usefulness and implementation barriers and facilitators. Intervention fidelity and tailoring are documented using structured session notes recording components delivered, toolbox elements selected, caregiver goals, and referrals/signposting.
Analyses are descriptive and focus on feasibility and process outcomes. Candidate outcome measures are summarized at baseline and follow-up to assess completeness and variability; exploratory pre-post changes may be presented without formal hypothesis testing. The intervention is considered low risk; discussions may elicit emotional discomfort, and participants may pause or discontinue at any time. Delivering professionals follow predefined signposting/referral pathways if significant distress is identified. Data are managed securely and reported in anonymized form in accordance with applicable data protection requirements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Support intervention | Experimental | Behavioral: Caregiver supportParticipants will receive the INSPIRE intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informal (unpaid) caregiver of an older adult with confirmed rheumatoid arthritis (RA)
- Aged ≥ 18 years
- Care recipient aged ≥ 65 years
- Able to provide informed consent
- Able to complete study questionnaires
Key exclusion criteria (3 listed)
- Severe cognitive impairment preventing participation
- Acute mental health crisis
- Other circumstances making it impracticable to complete the intervention and follow-up assessments
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 |
|---|---|---|
| Caregiver supportIntervention: INSPIRE INSPIRE is delivered by a trained healthcare professional with rheumatology expertise and experience in psychosocial support and service navigation. The intervention runs over approximately twelve weeks and includes an initial consultation, follow-up, and a final consultation. The initial consultation (about 60-90 minutes) takes place at home or in the clinic and is guided by the caregiver's CBS pro-file. It focuses on recognizing and validating the caregiver role, identifying the most burdensome is-sues, exploring underlying causes, and establishing realistic goals. Based on the needs identified, the caregiver is introduced to a tailored toolbox of resources and referral pathways that may include emotional or psychological support options, guidance on managing practical and physical strain, support for social isolation, communication and relationship support, disease-related education, and assistance navigating municipal and health system services. | Behavioural | Support intervention |
Primary outcome
Recruitment rate
Time frame: 3 months
Recruitment rate will be assessed as the number of caregivers recruited out of the number of eligible caregivers
Retention rate
Time frame: 3 months
Retention rate will be assessed as the number of participants who withdrew from the study out of the total number of participants.
Intervention deliverability
Time frame: 3 months
Number of sessions completed
Intervention deliverability
Time frame: 3 months
Session duration
Intervention deliverability
Time frame: 3 months
Session mode
6 secondary outcomes
Fidelity
Time frame: 3 months
Data completeness
Time frame: 3 months
Acceptability
Time frame: 3 months
Caregiver burden
Time frame: Baseline and 3 months
Health related quality of life
Time frame: Baseline and 3 months
Physical function
Time frame: Baseline
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 17 Mar 2026.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request
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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.
Signe Abild, Master of Science contact
Bente Esbensen, Professor principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver support in people with Rheumatic Arthritis, run by Glostrup University Hospital, Copenhagen 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 9 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 17 Mar 2026. 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?
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 Luise Lindgren, Ph.D. (22509390 ext. 0045, luise.holberg.lindgren@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 3 months). The study lists 5 primary outcomes in all. 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 17 Mar 2026.