MultimorbidityNCT07899723
TimelyCare - A Proactive Primary Care Model: Delivering the Right Care at the Right Time for Individuals at Risk of High Care Consumption
A study testing Timely Care, in people with Multimorbidity and Integrated Care, run by Linnaeus University at 1 site in Sweden.
Trial summary
Healthcare systems face persistent challenges in providing coordinated, proactive care for individuals with complex health needs, resulting in high vulnerability to fragmented care, acute clinical deterioration, and frequent emergency hospital admissions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multimorbidity, Integrated Care, Primary Care Patients With Chronic Conditions
- What is being tested?
- Timely Care,
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 30 Sep 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling adults aged 18 years or older registered at a participating primary healthcare center (PHCC) in Region Kalmar
- Identified as being at high risk of fragmented care and high emergency healthcare utilization based on the TimelyCare combined risk algorithm:
- Morbidity Resource Utilization Bands (RUB) levels 4 or 5 (high morbidity and care consumption via the Adjusted Clinical Groups [ACG] system), AND
- Residence in a socioeconomically vulnerable Demographic Statistical Area (DeSO).
- Able to provide informed consent or proxy consent (via family caregiver/legal representative) in accordance with ethical approval
Who cannot join
- Individuals who relocate outside Region Kalmar or transfer registration to a non-participating primary healthcare center during the measurement period.
- Individuals with missing diagnostic, healthcare consumption, or residential geocoding data required for RUB/DeSO risk stratification
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TimelyCare - A Proactive Primary Care Model for Delivering Appropriate Care to Individuals at Risk of High Care Consumption: Study Protocol for a Stepped-Wedge, Cluster-Controlled Trial With Economic and Process Evaluation
Healthcare systems face persistent challenges in providing coordinated, proactive care for individuals with complex health needs, resulting in high vulnerability to fragmented care, acute clinical deterioration, and frequent emergency hospital admissions. TimelyCare is a proactive, multimodal primary care intervention designed to improve care continuity, optimize hospital-to-home transitions, and reduce unplanned acute healthcare dependency among high-risk individuals. This study evaluates the TimelyCare model using a pragmatic, stepped-wedge matched cluster-controlled trial (SW-CRT) with an open dynamic cohort across 12-15 primary healthcare centers in Region Kalmar, Sweden.
The intervention targets individuals identified through an innovative combined risk algorithm integrating high morbidity (Resource Utilization Bands [RUB] levels 4-5) and sociodemographic vulnerability (Demographic Statistical Areas [DeSO]). The primary hypothesis is that exposure to the TimelyCare intervention will significantly reduce unplanned hospital admission rates over an 18-month follow-up period compared with usual care, while improving patient-experienced continuity, health-related quality of life, and healthcare cost-effectiveness.
Read the detailed description
The TimelyCare study comprises a pre-implementation risk-modeling phase and three integrated work packages combining trial evaluation, co-design, and process evaluation: Target Population \& Identification Algorithm: Eligible participants are community-dwelling adults classified at RUB/DeSO levels 4 or 5 within participating primary healthcare centers
. The algorithm combines Adjusted Clinical Groups (ACG) morbidity levels (RUB 4-5) with localized socio-geographic disadvantage (DeSO) to target individuals facing a compounded risk of fragmented care and high emergency care utilization.
Intervention Components: The TimelyCare model integrates four synergistic clinical components:
Component A (Coordinated Care Transitions): Standardized, cross-boundary transition protocols and communication pathways (e.g., Cosmic LINK®) between specialized hospital care, primary care, and municipal home care to eliminate discharge information gaps . Component B (Designated GP / Care Contact): Assignment of a named General Practitioner (GP) and/or fixed care-contact nurse to guarantee relational and informational stability . Component C (Proactive Serious Illness Conversations): Structured, values-based care-planning conversations conducted with patients and family carers using the Swedish-adapted Serious Illness Conversation Guide (SICG)
. Component D (Emergency Decision Support \& Fast-Track Pathways): Interprofessional decision-support routines and direct-access escalation protocols for ambulance staff, municipal nurses, and primary care clinicians during acute home deteriorations, bypassing unnecessary emergency department delays
.
Study Design \& Methodological Framework:
Stepped-Wedge Cluster Trial: 12-15 primary healthcare center clusters will be sequentially rolled out into the intervention phase in stepped steps over an 18-month period, ensuring all clusters receive the intervention while allowing both within- and between-cluster comparisons . Open Dynamic Cohort: Reflecting routine clinical practice, an open cohort of approximately 6,000-9,000 eligible high-risk patients will be followed over an 18-month post-implementation window
.
Outcome Measures:
Primary Outcome: Rate of unplanned hospital admissions per 1,000 person-years, evaluated quarterly using regional healthcare registers via Interrupted Time Series (ITS) with segmented regression
. Secondary Utilization Outcomes: Quarterly rates of emergency department visits, 30-day unplanned readmissions, average length of stay (ALOS), ambulance transport frequency, specialist outpatient visits, and all-cause mortality
. Patient-Reported Endpoints (PROMs/PREMs): Patient-experienced continuity evaluated via the Patient-Experienced Continuity of Care Questionnaire (PECQ; short version) and health-related quality of life via EQ-5D-5L (and QALYs), surveyed at baseline, 6, 12, and 18 months and analyzed using multilevel regression.
Health Economic Endpoints: Direct healthcare costs (Cost per Patient database, Prescribed Drug Register) and municipal care expenditure, evaluated via Cost-Consequence Analysis (CCA) and Cost-Effectiveness Analysis (CEA) calculating the Incremental Cost-Effectiveness Ratio (ICER) per avoided hospital admission.
Process Evaluation: A Consolidated Framework for Implementation Research (CFIR 2.0)-guided mixed-methods evaluation assessing staff implementation capacity (IPAT questionnaire at baseline, 6, 12, 18 months), qualitative stakeholder interviews, fidelity, reach, and contextual adaptations mapped via the Implementation Research Logic Model (IRLM).
- Conditions
- Multimorbidity, Integrated Care, Primary Care Patients With Chronic Conditions, Coordination, Administrative
- Being tested
- Timely Care,
- Keywords
- Continuity of patient Care, Health Services Accessibility, Integrated Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timely Care,Behavioural
The TimelyCare intervention combines four synergistic clinical components administered through interprofessional collaboration across regional primary healthcare centers (PHCCs), hospital wards, municipal home care, and emergency medical services:
Component A: Coordinated Care Transitions Intervention Administered: Standardized transition protocols and digital communication pathways to bridge information gaps during hospital-to-home discharges Component B: Designated GP / Care Contact. Intervention Administered: Formal assignment of a named General Practitioner (GP) and/or a designated care-contact nurse Component C: Proactive Serious Illness Conversations Intervention Administered: Structured, proactive care-planning discussions using the Swedish-adapted Serious Illness Conversation Guide Component D: Emergency Decision Support \& Fast-Track Pathways Intervention Administered: Decision-support tools and fast-track escalation protocols for managing acute home-based deteriorations
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Control Phase) | No intervention | Standard primary care, municipal home care, and hospital discharge routines prior to intervention rollout at each participating primary healthcare center cluster |
| Arm 2 (Intervention Phase) | Experimental | Implementation of the multimodal TimelyCare model, comprising four core components Receives: Behavioral: Timely Care, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned Hospital Admission Rate
Rate of unplanned emergency hospital admissions per 1,000 person-years. Evaluated using quarterly regional healthcare register data via Interrupted Time Series (ITS) with segmented regression analysis to assess post-implementation changes compared to the baseline trajectory
Measured: Baseline (pre-intervention retrospective trajectory, 2014-2025) through 18-month post-implementation follow-up (September 2025-March 2027)
Secondary outcomes (7)
Emergency Department (ED) Visit Rate
Rate of emergency department visits and emergency admissions per 1,000 person-years
Measured: Quarterly from baseline up to 18 months post-implementation
30-Day Unplanned Hospital Readmissions
Proportion of patients experiencing an unplanned hospital readmission within 30 days of discharge
Measured: Quarterly over the 18-month follow-up period
Average Length of Hospital Stay
Average duration of unplanned hospital stay measured in days
Measured: Quarterly over the 18-month follow-up period
Patient-Experienced Continuity of Care Score
Evaluated using the validated Patient-Experienced Continuity of Care Questionnaire (PECQ; short version), measuring four dimensions: informational, relational, management, and knowledge continuity
Measured: Baseline, 6, 12, and 18 months post-enrolment
Health-Related Quality of Life (HRQoL) and QALYs
Evaluated using the EQ-5D-5L index score and Visual Analogue Scale (VAS), converted to Quality-Adjusted Life Years (QALYs) for health economic utility analysis
Measured: Baseline, 6, 12, and 18 months post-enrolment
Incremental Cost-Effectiveness Ratio (ICER)
Incremental cost per avoided unplanned hospital admission, integrating direct healthcare costs (DRG/Cost per Patient database, Prescribed Drug Register) and municipal home care expenditures
Measured: Baseline to 18-month post-implementation horizon
Implementation Capacity Score (IPAT)
Measured among healthcare staff using the Implementation Process Assessment Tool (IPAT) to evaluate organizational readiness, implementation capacity, and sustainment over time
Measured: Baseline, 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-Wedge Cluster-Controlled Trial Design with Open Dynamic Cohort: This study employs a pragmatic stepped-wedge matched cluster-controlled trial (SW-CRT) design across primary healthcare centers (PHCCs) serving as clusters in the Region. The trial utilizes a sequential rollout structure where all participating clusters transition from the control condition (usual care) to the intervention condition (TimelyCare) across distinct step periods Clusters: Approximately 12-18 participating primary healthcare centers are grouped into 3 cluster steps (approx. 6 PHCCs per cluster step). Baseline Control Phase (C): All clusters begin simultaneously in the control phase, receiving standard primary care, municipal home care, and hospital discharge routines. Sustainment \& Post-Implementation Phase (FU/PI): Following intervention introduction, clusters are maintained in the active intervention phase with ongoing facilitation and follow-up until trial completion in 2028
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Kalmar County, Uppsala University
- Responsible party
- Principal investigator, Mirjam Ekstedt, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899723
- Sponsor's protocol ID
- Forte 2024-01064
- Other IDs
- 2024-01064
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No individual participant data (IPD) will be shared. The data contain confidential participant information, and consent for external sharing of individual-level data was not obtained from participants. To protect participant privacy and comply with ethical and legal requirements, IPD will not be made available. Non-confidential information, such as study protocols, aggregate results, and summary data, may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TimelyCare - A Proactive Primary Care Model for Delivering Appropriate Care to Individuals at Risk of High Care Consumption: Study Protocol for a Stepped-Wedge, Cluster-Controlled Trial With Economic and Process Evaluation
- ClinicalTrials.gov ID
- NCT07899723
- Acronym / sponsor ID
- Forte 2024-01064
- Conditions
- Multimorbidity, Integrated Care, Primary Care Patients With Chronic Conditions, Coordination, Administrative
- Keywords
- Continuity of patient Care, Health Services Accessibility, Integrated Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Collaborators
- Region Kalmar County, Uppsala University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Oct 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.
Healthcare systems face persistent challenges in providing coordinated, proactive care for individuals with complex health needs, resulting in high vulnerability to fragmented care, acute clinical deterioration, and frequent emergency hospital admissions. TimelyCare is a proactive, multimodal primary care intervention designed to improve care continuity, optimize hospital-to-home transitions, and reduce unplanned acute healthcare dependency among high-risk individuals. This study evaluates the TimelyCare model using a pragmatic, stepped-wedge matched cluster-controlled trial (SW-CRT) with an open dynamic cohort across 12-15 primary healthcare centers in Region Kalmar, Sweden.
The intervention targets individuals identified through an innovative combined risk algorithm integrating high morbidity (Resource Utilization Bands [RUB] levels 4-5) and sociodemographic vulnerability (Demographic Statistical Areas [DeSO]). The primary hypothesis is that exposure to the TimelyCare intervention will significantly reduce unplanned hospital admission rates over an 18-month follow-up period compared with usual care, while improving patient-experienced continuity, health-related quality of life, and healthcare cost-effectiveness.
Detailed description
The TimelyCare study comprises a pre-implementation risk-modeling phase and three integrated work packages combining trial evaluation, co-design, and process evaluation: Target Population \& Identification Algorithm: Eligible participants are community-dwelling adults classified at RUB/DeSO levels 4 or 5 within participating primary healthcare centers
. The algorithm combines Adjusted Clinical Groups (ACG) morbidity levels (RUB 4-5) with localized socio-geographic disadvantage (DeSO) to target individuals facing a compounded risk of fragmented care and high emergency care utilization.
Intervention Components: The TimelyCare model integrates four synergistic clinical components:
Component A (Coordinated Care Transitions): Standardized, cross-boundary transition protocols and communication pathways (e.g., Cosmic LINK®) between specialized hospital care, primary care, and municipal home care to eliminate discharge information gaps . Component B (Designated GP / Care Contact): Assignment of a named General Practitioner (GP) and/or fixed care-contact nurse to guarantee relational and informational stability . Component C (Proactive Serious Illness Conversations): Structured, values-based care-planning conversations conducted with patients and family carers using the Swedish-adapted Serious Illness Conversation Guide (SICG)
. Component D (Emergency Decision Support \& Fast-Track Pathways): Interprofessional decision-support routines and direct-access escalation protocols for ambulance staff, municipal nurses, and primary care clinicians during acute home deteriorations, bypassing unnecessary emergency department delays
.
Study Design \& Methodological Framework:
Stepped-Wedge Cluster Trial: 12-15 primary healthcare center clusters will be sequentially rolled out into the intervention phase in stepped steps over an 18-month period, ensuring all clusters receive the intervention while allowing both within- and between-cluster comparisons . Open Dynamic Cohort: Reflecting routine clinical practice, an open cohort of approximately 6,000-9,000 eligible high-risk patients will be followed over an 18-month post-implementation window
.
Outcome Measures:
Primary Outcome: Rate of unplanned hospital admissions per 1,000 person-years, evaluated quarterly using regional healthcare registers via Interrupted Time Series (ITS) with segmented regression
. Secondary Utilization Outcomes: Quarterly rates of emergency department visits, 30-day unplanned readmissions, average length of stay (ALOS), ambulance transport frequency, specialist outpatient visits, and all-cause mortality
. Patient-Reported Endpoints (PROMs/PREMs): Patient-experienced continuity evaluated via the Patient-Experienced Continuity of Care Questionnaire (PECQ; short version) and health-related quality of life via EQ-5D-5L (and QALYs), surveyed at baseline, 6, 12, and 18 months and analyzed using multilevel regression.
Health Economic Endpoints: Direct healthcare costs (Cost per Patient database, Prescribed Drug Register) and municipal care expenditure, evaluated via Cost-Consequence Analysis (CCA) and Cost-Effectiveness Analysis (CEA) calculating the Incremental Cost-Effectiveness Ratio (ICER) per avoided hospital admission.
Process Evaluation: A Consolidated Framework for Implementation Research (CFIR 2.0)-guided mixed-methods evaluation assessing staff implementation capacity (IPAT questionnaire at baseline, 6, 12, 18 months), qualitative stakeholder interviews, fidelity, reach, and contextual adaptations mapped via the Implementation Research Logic Model (IRLM).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-Wedge Cluster-Controlled Trial Design with Open Dynamic Cohort: This study employs a pragmatic stepped-wedge matched cluster-controlled trial (SW-CRT) design across primary healthcare centers (PHCCs) serving as clusters in the Region. The trial utilizes a sequential rollout structure where all participating clusters transition from the control condition (usual care) to the intervention condition (TimelyCare) across distinct step periods Clusters: Approximately 12-18 participating primary healthcare centers are grouped into 3 cluster steps (approx. 6 PHCCs per cluster step). Baseline Control Phase (C): All clusters begin simultaneously in the control phase, receiving standard primary care, municipal home care, and hospital discharge routines. Sustainment \& Post-Implementation Phase (FU/PI): Following intervention introduction, clusters are maintained in the active intervention phase with ongoing facilitation and follow-up until trial completion in 2028
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Control Phase) | No intervention | –Standard primary care, municipal home care, and hospital discharge routines prior to intervention rollout at each participating primary healthcare center cluster |
| Arm 2 (Intervention Phase) | Experimental | Behavioral: Timely Care,Implementation of the multimodal TimelyCare model, comprising four core components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling adults aged 18 years or older registered at a participating primary healthcare center (PHCC) in Region Kalmar
- Identified as being at high risk of fragmented care and high emergency healthcare utilization based on the TimelyCare combined risk algorithm:
- Morbidity Resource Utilization Bands (RUB) levels 4 or 5 (high morbidity and care consumption via the Adjusted Clinical Groups [ACG] system), AND
- Residence in a socioeconomically vulnerable Demographic Statistical Area (DeSO).
- Able to provide informed consent or proxy consent (via family caregiver/legal representative) in accordance with ethical approval
Key exclusion criteria (2 listed)
- Individuals who relocate outside Region Kalmar or transfer registration to a non-participating primary healthcare center during the measurement period.
- Individuals with missing diagnostic, healthcare consumption, or residential geocoding data required for RUB/DeSO risk stratification
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 |
|---|---|---|
| Timely Care,The TimelyCare intervention combines four synergistic clinical components administered through interprofessional collaboration across regional primary healthcare centers (PHCCs), hospital wards, municipal home care, and emergency medical services: Component A: Coordinated Care Transitions Intervention Administered: Standardized transition protocols and digital communication pathways to bridge information gaps during hospital-to-home discharges Component B: Designated GP / Care Contact. Intervention Administered: Formal assignment of a named General Practitioner (GP) and/or a designated care-contact nurse Component C: Proactive Serious Illness Conversations Intervention Administered: Structured, proactive care-planning discussions using the Swedish-adapted Serious Illness Conversation Guide Component D: Emergency Decision Support \& Fast-Track Pathways Intervention Administered: Decision-support tools and fast-track escalation protocols for managing acute home-based deteriorations | Behavioural | Arm 2 (Intervention Phase) |
Primary outcome
Unplanned Hospital Admission Rate
Time frame: Baseline (pre-intervention retrospective trajectory, 2014-2025) through 18-month post-implementation follow-up (September 2025-March 2027)
Rate of unplanned emergency hospital admissions per 1,000 person-years. Evaluated using quarterly regional healthcare register data via Interrupted Time Series (ITS) with segmented regression analysis to assess post-implementation changes compared to the baseline trajectory
7 secondary outcomes
Emergency Department (ED) Visit Rate
Time frame: Quarterly from baseline up to 18 months post-implementation
30-Day Unplanned Hospital Readmissions
Time frame: Quarterly over the 18-month follow-up period
Average Length of Hospital Stay
Time frame: Quarterly over the 18-month follow-up period
Patient-Experienced Continuity of Care Score
Time frame: Baseline, 6, 12, and 18 months post-enrolment
Health-Related Quality of Life (HRQoL) and QALYs
Time frame: Baseline, 6, 12, and 18 months post-enrolment
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: Baseline to 18-month post-implementation horizon
Implementation Capacity Score (IPAT)
Time frame: Baseline, 6, 12, and 18 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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided. No individual participant data (IPD) will be shared. The data contain confidential participant information, and consent for external sharing of individual-level data was not obtained from participants. To protect participant privacy and comply with ethical and legal requirements, IPD will not be made available. Non-confidential information, such as study protocols, aggregate results, and summary data, may 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timely Care, in people with Multimorbidity and Integrated Care, run by Linnaeus University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 27 Oct 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 Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Unplanned Hospital Admission Rate (time frame: Baseline (pre-intervention retrospective trajectory, 2014-2025) through 18-month post-implementation follow-up (September 2025-March 2027)). 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 27 Oct 2026.