Complex PatientNCT05878054
Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
A study testing Proactive, integrated and personalised care in people with Complex Patient and Multimorbidity, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Hotspotters are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. Reliable data on (cost-)effective interventions for these patients are scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Patient, Multimorbidity, Psychosocial Problem
- What is being tested?
- Proactive, integrated and personalised care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Aug 2023to 31 Dec 2026
- 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
- The patients are ≥ 18yrs
- The patients are registered within one of the participating GP practices.
- Patients with at least two acute care encounters in the past 12 months. Acute care encounter is defined as an encounter with out-of-hours GP service, emergency care or acute mental health care.Patients have problems registered in the GP Information system on at least two out of three of the following domains: somatic, mental or social. Somatic problems is having at least one ICPC code on the problem list. Mental problems is having at least one ICPC code from the "P"-chapter on either the problem list, as a reason for encounter, and/or having medication prescribed related to mental health problems. Social problems is having at least one ICPC code from the "Z"-chapter or as reason for encounter, and/or having medication prescribed related to social problems.
Who cannot join
- The patient is terminal.
- The patient is living in a residential home.
- The patient has dementia or a disability that prevents them from communicating effectively.The patient already has experience with the positive health tool.
- The patient is not competent to make decisions concerning their health. This wil be assessed by the patient's own general practitioner.
- Veto of the GP
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical centre, department of Public Healht and Primary care (PHEG), location Health Campus The Hague
Leiden, 2333ZA
About this study
Official title: The Hotspotters Project. Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
Hotspotters are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. Reliable data on (cost-)effective interventions for these patients are scarce. The goal of this study is to assess the cost-effectiveness of pro-active and integrated care. This approach includes: an intake consultation with Positive Health; multidisciplinary meetings with physician, mental healthcare nurse, social worker and the patient; a personalised care plan and proactive care management. We aim to include 200 patients, divided over 20 primary care practices.
Read the detailed description
People with complex problems on multiple life domains, so called 'hotspotters', receive fragmented care. This is difficult to manage by patients and care providers , leading to little effect of care and persistent unmet needs. The accumulation and complexity of problems often leads to high medical expenses. Next to their high medical spending levels, hotspotters´ experiences with the healthcare system are low as the healthcare system is not (yet) successful in dealing with their needs. Interventions aimed at the complex situation of hotspotters in our current healthcare system might benefit by applying a Triple Aim approach. This approach aims to simultaneously improve the individual experience of care, reduce the cost of care per capita and improve the health of populations by offering proactive integrated care.
Is proactive integrated care costeffective and does it result in better patients experience than usual care after 12 months for patients with problems on multiple life domains? The intervention consists of: intake consultation assessing health on multiple domains using positive health or similar tool; multidisciplinary meetings with physician, mental healthcare nurse, social worker and patient, personalised care plan and proactive care management.
This stepped wedge cluster RCT aims to include 200 patients, divided over 20 primary care practices. All practices start with an observation period (2-8months), followed by the intervention (12 months) and follow-up (2-8months). Total duration of intervention is 22 months. We define Hotspotters as patients with at least two incidents of acute care utilisation (defined as out-of-office GP consultations, acute psychiatric care, emergency department visits and unplanned admissions) during the past year, and problems on two out of three health domains (chronic somatic, mental and/or social problems) based on diagnosis (coded with the International Classification of Primary Care) or medication (ATC) coding.
Primary outcome: Incremental cost-effectiveness from a societal perspective. Information on cost will be based on patient-reported data obtained by questionnaires supplied with data from the GP medical files (Huisarts informatie system, HIS) and CBSmicrodata. To assess the effectiveness the EQ-5D-5L will be used for determining quality of life.
Secondary outcomes: Insight into patients experience of care, quality of life, proactive coping, and self-efficacy. This information will be gathered using interviews and questionnaires (SF-12, UPCC, PAM-13 and SE+IN itemlist). Process evaluation with the involved care professionals, integration level, the nature of the communication between healthcare provider and patient (HCCQ, OPTION5), and acceptability (AIM), appropriateness (IAM), feasibility (FIM) ,and perceived and experienced effectiveness of the intervention.
- Conditions
- Complex Patient, Multimorbidity, Psychosocial Problem, Chronic Disease
- Being tested
- Proactive, integrated and personalised care
- Keywords
- high care utilizer, complex patient, problems on multiple life domains, frequent flyer, hotspotter, high needs patient, integrated care, proactive care, personalised care, personalised care plan, positive health tool, multimorbidity, psychosocial problem
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive, integrated and personalised careOther
During the intervention patients receive proactive, integrated and personalised care. An intake consultation using Positive Health tool, or a similar method, the needs of each patient is assessed. In a multidisciplinary meeting with the GP, mental health care practice nurse, a social worker and the patient, a personalised care plan is made. The personal is executed and a care coordinator maintains proactive contact with the patient. Clinical follow-up will be done via a second multidisciplinary meeting.
| Study group | Role | What they receive |
|---|---|---|
| Control period 2 months | Other | 2 months control period, followed by 12 months intervention, followed by 8 months observation Receives: Other: Proactive, integrated and personalised care |
| Control period 4 months | Other | 4 months control period, followed by 12 months intervention, followed by 6 months observation Receives: Other: Proactive, integrated and personalised care |
| Control period 6 months | Other | 6 months control period, followed by 12 months intervention, followed by 4 months observation Receives: Other: Proactive, integrated and personalised care |
| Control period 8 months | Other | 8 months control period, followed by 12 months intervention, followed by 2 months observation Receives: Other: Proactive, integrated and personalised care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs of care
Costs of care from a societal perspective is the summ of costs of care and loss of productivity due to illness or disease.
Data on frequency and type of care utilization is gathered from the GP medical file, supplied with questions on mental health care use and need for addiction care. Productivity loss is determined via questionnaire. This data will be translated into cost using standard cost prices from the Dutch guideline for economic evaluations.
Cost of care, together with Quality of life, will be used to assess cost-effectiveness from a societal perspective.
Measured: 22 months
Quality adjusted life years
QALY measured by recurring EQ-5D-5L. Quality of life, together with cost of care, will be used to assess cost-effectiveness from a societal perspective.
Measured: 22 months
Secondary outcomes (13)
Self-regulation: Patient activation measure (PAM-13)
Self-regulation consists of measures of proactive coping, patient activation, self-efficacy and intention.
The first is the validated Patient activation Measure (PAM-13). Patient Activation Measure (PAM-13), a validated 13-item questionnaire, assesses self-reported knowledge, skills and confidence in health management on 4-point scales ranging from 1 (totally disagree) to 4 (totally agree).
Measured: 22 months
Self-regulation: Utrechtse Proactive Coping Compentence scale (UPCC)
Self-regulation consists of measures of proactive coping, patient activation, self-efficacy and intention.
The Utrecht Proactive Coping Competence scale (UPCC) is a validated 21-item questionnaire that measures self-rated competence on proactive coping with 4-point scales ranging from 1 (not good) to 4 (very good)
Measured: 22 months
Self-regulation: self-efficacy and intention itemlist (SE+IN itemlist)
Self-regulation consists of measures of proactive coping, patient activation, self-efficacy and intention. The Self-efficacy and Intention itemlist, specifically created for this study, measures self-management, self-efficacy, the intention to perform certain self-management behaviors and the presence of certain self-management behaviors.
Action self-efficacy ("I am confident in my abilities to [ …] " and maintenance self-efficacy ("I am confident in my abilities to [….] when encountering obstacles") will be assessed in the Self-efficacy and Intention(SE+IN) itemlist for 8 items using 5-point scales, ranging from 1 (totally disagree) to 5 (totally agree). This addresses four key behaviours selected for the purpose of this study (adequate selfcare, maintaining daily structure, discussing concerns with care professionals, asking for help in a timely manner). Behavioural execution and intention to perform will also be assessed for each behaviour.
Measured: 22 months
Experience of care: Healthcare climate questionnaire (HCCQ)
Experience of care: using measures of patient satisfaction, autonomy-supportive care and qualitative evaluation
Researchers evaluate patients experiences with the personalised, integrated and proactive care approach using questionaires (HCCQ and mNPS, administerd 6 months after intervention start) and a qualitative approach (after intervention ends). The Health Care Climate Questionnaire (HCCQ) is a questionnaire on perceived degree of autonomy. It consists of 6-items, scored using 7-point likert scales. A higher score means that patients perceive a higher degree of autonomy.
Measured: 22 months
Experience of care: modified Net Promotor scale (mNPS)
Experience of care: using measures of patient satisfaction, autonomy-supportive care and qualitative evaluation
Researchers evaluate patients experiences with the personalised, integrated and proactive care approach using questionaires (HCCQ and mNPS, administerd 6 months after intervention start) and a qualitative approach (after intervention ends). The modified Net Promotor Scale (mNPS) consists of 2 patient-satisfaction-related items that are each scored between 0 and 10. A higher score means a higher satisfaction with the care received.
Measured: 22 months
Experience of care: qualitative assessment
Experience of care uses measures of patient satisfaction, autonomy-supportive care and qualitative evaluation.
Researchers evaluate patients experiences with the personalised, integrated and proactive care approach with both questionaires and a qualitative by means of an individual interview. After the intervention, patients are invited for an individual interview to gather insight into the experiences of patients.
Measured: 22 months
Administering of Positive Health methodology
The intake consultation and the first multidisciplinary meeting will be audio recorded. The audio-record of the intake as well as the filled-out questionnaire or spiderweb from the intake will be used in the qualitative analysis of positive health methodology use. Themes, conversation techniques and the positive health topics addressed will be evaluated. Both deductive and inductive analyses will be employed to assess the use of positive health methodology, the importance of discussed life domains, patients' needs, problems and wishes, and how the personalised care plan was formed.
Measured: 22 months
Health-related quality of life: short-form 12 health survey
Quality of life will also be assessed using the validated SF-12(12-items), including 8 dimensions, namely: bodily, pain, vitality (energy and fatigue), general mental health (psychological distress and well-being), general health perceptions, limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of emotional problems, and limitations in usual role activities because of physical health problems. Items are scored on a 3- or 5-points likert scale. The total SF=12 score ranges from 12 to 56 and a lower score means a better outcome.
This questionnaire is administered thrice: at the start and end of intervention, and two months after ending the intervention.
Measured: 22 months
Acceptability of Intervention Measure (AIM)
Acceptability, appropriateness, and feasibility will be measured using the The Acceptability of Intervention Measure (AIM). This will be done before the intervention starts and right after the intervention for each group of GP's. This information will be gathered from care professionals working at one of the participating practices.
Measured: 22 months
Level of shared decision making
Level of shared decision making will be based on audio recordings which will be scored by two independent observers using the validated OPTION5 questionnaire. If a participant is not comfortable with these recordings, the recordings may be skipped without further consequence for study participation.
Measured: 22 months
Intervention Appropriateness Measure (IAM)
Intervention Appropriateness Measure (IAM), together with Feasibility of Intervention Measure (FIM), measures implementation outcomes that are often considered "leading indicators" of implementation success. This will be done before the intervention starts and right after the intervention for each group of GP's. This information will be gathered from care professionals working at one of the participating practices.
Measured: 22 months
Feasibility of Intervention Measure (FIM)
Feasibility of Intervention Measure (FIM), together with Intervention Appropriateness Measure (IAM), measures implementation outcomes that are often considered "leading indicators" of implementation success. This information will be gathered from care professionals working at one of the participating practices.
Measured: 22 months
Process evaluation following RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance
Data on recruitment and population reach will be gathered during participant inclusion. Process evaluation of the study will be done simultaneous following the RE-AIM framework, thus providing insight on practicalities for future implementation. The five steps of the RE-AIM framework are:
- Reach of target population: the number, proportion and representativeness of participants included in the study.
- Effectiveness (or efficacy): the impact of the Hotspotters intervention is assessed in the primary outcome.
- Adoption: The number, proportion and representativeness of care providers (that partook in the study) that is willing to initiate or continue the intervention outside of the study-context.
- Implementation: the level of fidelity to intervention protocol per GP practice.
- Maintenance: The extend in which the intervention becomes part of the routine care practice.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start2 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Complex PatientStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rcvos, Leiden University Medical Center
- Investigators
- Rimke Vos, dr, Principal investigator, Leiden University medical centre, health campus The HagueMarc Bruijnzeels, dr, Principal investigator, Leiden University medical centre, health campus The Hague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878054
- Sponsor's protocol ID
- HTSPT
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiemes V, Leming KA, Borgdorff H, Bruijnzeels MA, van Gestel LC, Adriaanse MA, van der Wel M, van den Akker-van Marle EM, Numans ME, Vos RC. Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use. BMJ Open. 2025 Aug 10;15(8):e087940. doi: 10.1136/bmjopen-2024-087940.
PubMed 40784776
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hotspotters Project. Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
- ClinicalTrials.gov ID
- NCT05878054
- Acronym / sponsor ID
- HTSPT
- Conditions
- Complex Patient, Multimorbidity, Psychosocial Problem, Chronic Disease
- Keywords
- high care utilizer, complex patient, problems on multiple life domains, frequent flyer, hotspotter, high needs patient, integrated care, proactive care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2023 (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.
Hotspotters are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. Reliable data on (cost-)effective interventions for these patients are scarce. The goal of this study is to assess the cost-effectiveness of pro-active and integrated care. This approach includes: an intake consultation with Positive Health; multidisciplinary meetings with physician, mental healthcare nurse, social worker and the patient; a personalised care plan and proactive care management. We aim to include 200 patients, divided over 20 primary care practices.
Detailed description
People with complex problems on multiple life domains, so called 'hotspotters', receive fragmented care. This is difficult to manage by patients and care providers , leading to little effect of care and persistent unmet needs. The accumulation and complexity of problems often leads to high medical expenses. Next to their high medical spending levels, hotspotters´ experiences with the healthcare system are low as the healthcare system is not (yet) successful in dealing with their needs. Interventions aimed at the complex situation of hotspotters in our current healthcare system might benefit by applying a Triple Aim approach. This approach aims to simultaneously improve the individual experience of care, reduce the cost of care per capita and improve the health of populations by offering proactive integrated care.
Is proactive integrated care costeffective and does it result in better patients experience than usual care after 12 months for patients with problems on multiple life domains? The intervention consists of: intake consultation assessing health on multiple domains using positive health or similar tool; multidisciplinary meetings with physician, mental healthcare nurse, social worker and patient, personalised care plan and proactive care management.
This stepped wedge cluster RCT aims to include 200 patients, divided over 20 primary care practices. All practices start with an observation period (2-8months), followed by the intervention (12 months) and follow-up (2-8months). Total duration of intervention is 22 months. We define Hotspotters as patients with at least two incidents of acute care utilisation (defined as out-of-office GP consultations, acute psychiatric care, emergency department visits and unplanned admissions) during the past year, and problems on two out of three health domains (chronic somatic, mental and/or social problems) based on diagnosis (coded with the International Classification of Primary Care) or medication (ATC) coding.
Primary outcome: Incremental cost-effectiveness from a societal perspective. Information on cost will be based on patient-reported data obtained by questionnaires supplied with data from the GP medical files (Huisarts informatie system, HIS) and CBSmicrodata. To assess the effectiveness the EQ-5D-5L will be used for determining quality of life.
Secondary outcomes: Insight into patients experience of care, quality of life, proactive coping, and self-efficacy. This information will be gathered using interviews and questionnaires (SF-12, UPCC, PAM-13 and SE+IN itemlist). Process evaluation with the involved care professionals, integration level, the nature of the communication between healthcare provider and patient (HCCQ, OPTION5), and acceptability (AIM), appropriateness (IAM), feasibility (FIM) ,and perceived and experienced effectiveness of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control period 2 months | Other | Other: Proactive, integrated and personalised care2 months control period, followed by 12 months intervention, followed by 8 months observation |
| Control period 4 months | Other | Other: Proactive, integrated and personalised care4 months control period, followed by 12 months intervention, followed by 6 months observation |
| Control period 6 months | Other | Other: Proactive, integrated and personalised care6 months control period, followed by 12 months intervention, followed by 4 months observation |
| Control period 8 months | Other | Other: Proactive, integrated and personalised care8 months control period, followed by 12 months intervention, followed by 2 months observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients are ≥ 18yrs
- The patients are registered within one of the participating GP practices.
- Patients with at least two acute care encounters in the past 12 months. Acute care encounter is defined as an encounter with out-of-hours GP service, emergency care or acute mental health care.Patients have problems registered in the GP Information system on at least two out of three of the following domains: somatic, mental or social. Somatic problems is having at least one ICPC code on the problem list. Mental problems is having at least one ICPC code from the "P"-chapter on either the problem list, as a reason for encounter, and/or having medication prescribed related to mental health problems. Social problems is having at least one ICPC code from the "Z"-chapter or as reason for encounter, and/or having medication prescribed related to social problems.
Key exclusion criteria (5 listed)
- The patient is terminal.
- The patient is living in a residential home.
- The patient has dementia or a disability that prevents them from communicating effectively.The patient already has experience with the positive health tool.
- The patient is not competent to make decisions concerning their health. This wil be assessed by the patient's own general practitioner.
- Veto of the GP
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 |
|---|---|---|
| Proactive, integrated and personalised careDuring the intervention patients receive proactive, integrated and personalised care. An intake consultation using Positive Health tool, or a similar method, the needs of each patient is assessed. In a multidisciplinary meeting with the GP, mental health care practice nurse, a social worker and the patient, a personalised care plan is made. The personal is executed and a care coordinator maintains proactive contact with the patient. Clinical follow-up will be done via a second multidisciplinary meeting. | Other | Control period 2 months, Control period 4 months, Control period 6 months, Control period 8 months |
Primary outcome
Costs of care
Time frame: 22 months
Costs of care from a societal perspective is the summ of costs of care and loss of productivity due to illness or disease. Data on frequency and type of care utilization is gathered from the GP medical file, supplied with questions on mental health care use and need for addiction care. Productivity loss is determined via questionnaire. This data will be translated into cost using standard cost prices from the Dutch guideline for economic evaluations. Cost of care, together with Quality of life, will be used to assess cost-effectiveness from a societal perspective.
Quality adjusted life years
Time frame: 22 months
QALY measured by recurring EQ-5D-5L. Quality of life, together with cost of care, will be used to assess cost-effectiveness from a societal perspective.
13 secondary outcomes
Self-regulation: Patient activation measure (PAM-13)
Time frame: 22 months
Self-regulation: Utrechtse Proactive Coping Compentence scale (UPCC)
Time frame: 22 months
Self-regulation: self-efficacy and intention itemlist (SE+IN itemlist)
Time frame: 22 months
Experience of care: Healthcare climate questionnaire (HCCQ)
Time frame: 22 months
Experience of care: modified Net Promotor scale (mNPS)
Time frame: 22 months
Experience of care: qualitative assessment
Time frame: 22 months
Administering of Positive Health methodology
Time frame: 22 months
Health-related quality of life: short-form 12 health survey
Time frame: 22 months
Acceptability of Intervention Measure (AIM)
Time frame: 22 months
Level of shared decision making
Time frame: 22 months
Intervention Appropriateness Measure (IAM)
Time frame: 22 months
Feasibility of Intervention Measure (FIM)
Time frame: 22 months
Process evaluation following RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance
Time frame: 22 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 24 Feb 2026.
- Derived from this study: PubMed 40784776Tiemes V, Leming KA, Borgdorff H, Bruijnzeels MA, van Gestel LC, Adriaanse MA, van der Wel M, van den Akker-van Marle EM, Numans ME, Vos RC. Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use. BMJ Open. 2025 Aug 10;15(8):e087940. doi: 10.1136/bmjopen-2024-087940.
Related trials for Complex Patient
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
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.
Rimke Vos, dr principal investigator
Leiden University medical centre, health campus The Hague
Marc Bruijnzeels, dr principal investigator
Leiden University medical centre, health campus The Hague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive, integrated and personalised care in people with Complex Patient and Multimorbidity, run by Leiden University Medical Center at 1 site in Netherlands.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 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 Netherlands. 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?
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?
Costs of care (time frame: 22 months). The study lists 2 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 NCT05878054, 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 24 Feb 2026.