Chronic ConditionEMBOSSNCT05972031
EMBOSS A Person-centred Integrated-care for Chronic Diseases in Patients of Low Socio Economic Status
A study testing Person-centred integrated care intervention in people with Chronic Condition and Chronic Conditions, Multiple, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
People of low socio economic status (SES) more often than others suffer from chronic diseases like diabetes mellitus, chronic obstructive pulmonary disease (COPD), or coronary diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Condition, Chronic Conditions, Multiple
- What is being tested?
- Person-centred integrated care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Jan 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently enrolled in any of the single disease management programmes (usual care) for DM2, COPD, asthma or CVD
Who cannot join
- Limited life expectancy (less than 3 months)
- Patients with high level of SES (or educational level > MBO2)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
RadboudUMC
Nijmegen
Hester Van Bommel, MSc, +31302349800, hester.vanbommel@radboudumc.nl
About this study
Official title: EMBOSS: Reach and Effect of a Person-centred Integrated-care Approach for Chronic Diseases and MultimorBidity in Patients of Low sOcio- Economic StatuS in General Practice
People of low socio economic status (SES) more often than others suffer from chronic diseases like diabetes mellitus, chronic obstructive pulmonary disease (COPD), or coronary diseases. Compared to others People of low SES more often have to deal with multiple diseases (multimorbidity) and experience worse health outcomes. The health literacy of people of low SES is often low. Current chronic disease management programs focus on reducing the burden of a single disease by prescribing medication, protocoled monitoring routines, or lifestyle advice.
However, the effectiveness of these interventions is low in people with low SES, as the interventions insufficiently take into account the specific problems and needs of this (multimorbid) population. A person-centered and integrated-care approach, that puts the patient at the center of care instead of the disease and in which care is tailored to the individual patient with chronic disease(s), seems to be more appropriate, but only when low SES people are closely involved in the development, testing, and evaluation of such an approach. Also, certain preconditions should be met, such as training of specific knowledge and skills of the healthcare professionals involved.
In the EMBOSS project, the investigators will develop, test, evaluate, and implement a person-centered integrated-care approach for and in close collaboration with people with low SES who have one or more chronic diseases. Thus, the EMBOSS study will have the potential to reducing health disparities in this group, to broadening the action perspectives of general practitioners and practice nurses for an increasing diverse patient population and to a better fit of lifestyle interventions in people of low SES.
Read the detailed description
In the Netherlands, 28% of the population is lowly educated, i.e. the level of education is MBO1 (secondary vocational education) or lower, which is the main indicator of low socioeconomic status. Low-educated people suffer 2-4 times more often than high-educated people from diabetes mellitus, COPD, coronary disease (often in combination) and of the risk factors contributing to these diseases. The healthy life-expectancy for low educated people is 14 years shorter, the health outcomes are worse (more complications of cardiovascular diseases and diabetes), because of high levels of chronic stress due to challenging living circumstances, negatively influencing self-confidence and executive functions, limited health and digital literacy - all determinants of effective self-management. Most people with chronic diseases are being cared for in general practice (GP). However, professionals in GP often struggle with the care for low-educated patients, experiencing difficulties in recognizing patients with low (health) literacy, and in adapting communication and advice to the needs of this group. Low-educated patients more often visit the GP, and are more often referred to costly secondary care.
Many interventions for chronic diseases fail to show effectiveness in low-SES groups. The reasons are multiple:
- materials and procedures used are too complicated,
- daily survival sets different priorities,
- communication and approach by healthcare professionals don't suit the needs and skills of this population, actions or materials are too expensive.
Effectiveness of interventions can be improved by involving low-SES patients in the development and by training healthcare professionals. Low-educated patients should be explicitly recruited in intervention evaluation studies as this population is underrepresented in clinical studies, which impedes generalizability of results. Chronic care for patients with diabetes mellitus type 2 (DM2), COPD and/or cardiovascular diseases (CVD) in GP is carried out through disease management programmes. However, major limitations of these programmes are that it focused on a single disease, while half of the patients suffers from multimorbidity. Also, the programmes do not truly reflect the needs of patients who experience this disease management as fragmented with too little attention for the partienst personal context. Therefore, a more generic disease management (GDM) programme including a person-centred and integrated-care (PC-IC) approach seems to be a promising strategy. Such an approach puts the patient at the centre of care, tailoring chronic care to the individual's needs and addressing all the issues important to him. It starts with a comprehensive biopsychosocial assessment of all relevant problems. Subsequently, a personalised treatment plan is made with individualised goals, actions and professionals involved. The programme responds to the needs and context of the 'whole' patient to provide the right care in the right place at the right time. It supposes to stimulate patient's self-management.
Currently, in the Netherlands, some regional projects with GDM programmes and PC-IC approaches are running, of which 'OPTIMA FORMA' may be the best known. This project started in 2018 and consists of three stages in which a GDM programme including a PC-IC approach is developed, tested and evaluated in three large Dutch primary care cooperatives, i.e Nijmegen, Arnhem, and Doetinchem. However, in 'OPTIMA FORMA' as in other ongoing projects, there is no specific attention for or involvement of people with low SES. This will obviously reduce the effectiveness of this approach in low SES patients, as one third of the population with chronic diseases consists of patients with low SES. The investigators there is an urgent need for PC-IC interventions that specifically address the needs of low SES population in order to be effective. Therefore, the investigators supported the three primary care cooperatives who participate in OPTIMA FORMA with the development of a GDM programme specifically for low SES patients. With help from patients with low SES and the healthcare professionals of the low SES patient, the investigators collected information on experiences, facilitators, and barriers from the previously conducted pilot study of OPTIMA FORMA PHASE2 (CMO 2021-8106).
The investigators used this information in co-creation sessions with patients with low SES and healthcare professionals to adjust the OPTIMA FORMA programme to a GDM programme that better suits the needs of low SES patients (EMBOSS programme).
The hypothesise off the EMBOSS programme will not only result in better outcomes of care in this group (and thus decreasing socio-economic health disparities), but also to a more effective role of GPs and practice nurses with more work satisfaction and less workload. In the current study our primary research question is:
What is the effectiveness of the EMBOSS intervention, i.e. a GDM programme including a PC-IC approach developed with and for low SES people with one or more chronic diseases compared to care as usual, i.e. SDM programmes for DM2, COPD and/or CVD in general practice? The investigators will perform a cluster randomized controlled trial with a follow-up time of 12 months.
- Conditions
- Chronic Condition, Chronic Conditions, Multiple
- Being tested
- Person-centred integrated care intervention
- Keywords
- Primary care, Person-centered, Integrated-care, Health literacy, Health disparities, Socio-economic status, General practice
- Medical subject headings
- Chronic Disease, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred integrated care interventionBehavioural
Also called Usual care
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Person-centred integrated care intervention | Experimental | The core of the person-centered approach is a cyclical process and for EMBOSS developed for patients with low SES. The practice nurse in the GP will act as case manager and can consult other health providers. The first step in the intervention is assessing the integral health status of the patient (health across multiple domains), using a visual conversation tool. The second step is discussing the results with the patient. Personal goals are formulated in the third step. In the fourth step, the healthcare professional and patient will choose through shared-decision making the most appropriate interventions and support to achieve these goals, which are documented in a personal plan. Next, referrals are made if necessary and the treatment is started. An evaluation is planned and carried out. All practices in the EMBOSS intervention group will be trained by Pharos on how to recognize and provide GDM to low SES patients using appropriate communication skills and the specific tools. Receives: Behavioral: Person-centred integrated care intervention |
| Usual care | No intervention | Practices in the control group provide care as usual, which consists of the SDM programmes according to the national care standards and General Practice guidelines (NHG) for DM2, COPD and CVD. According to these protocolised programmes, patients with COPD, CVD or DM2 visit their general practice at a standard frequency per year (1 - 4 times) and standard monitoring measurements and topics are discussed. The practices that are randomised to the control group will not receive any additional training related to this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported health-related quality of life Physical Health
Global Physical Health [Time Frame: Baseline, 6 months, 12 months] Physical aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better physical aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
Measured: 12 months
patient-reported health-related quality of life Mental health
Global Mental Health [Time Frame: Baseline, 6 months, 12 months] Mental aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better mental aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
Measured: 12 months
Patient-experienced quality of care
atient-experienced quality of care [Time Frame: Baseline, 6 months, 12 months] Person-centredness of care as measured by the Person Centred Coordinated Care Experience Questionnaire (P3CEQ) instrument; minimum score 0, maximum score 30, higher score equals better P3CE.
Measured: 12 months
Secondary outcomes (9)
Patient activation as measured by PAM
Patient activation as measured by the Patient Activation Measure instrument; minimum 0, maximum 100, higher score equals better patient activation.
Measured: Baseline, 6 months, 12 months
Health-related quality of life as measured by the EQ-5D-5L instrument
Health-related quality of life as measured by the EQ-5D-5L instrument; minimum 0, maximum 1, higher score equals better HrQoL
Measured: Baseline, 6 months, 12 months
BMI
Combined length and weight according to general practice data (registered for normal care)
Measured: Baseline, 6 months, 12 months
HbA1c
according to general practice data
Measured: Baseline, 6 months, 12 months
Blood glucose
according to general practice data
Measured: Baseline, 6 months, 12 months
Blood LDL-cholesterol
according to general practice data
Measured: Baseline, 6 months, 12 months
Systolic and diastolic blood pressure
according to general practice data
Measured: Baseline, 6 months, 12 months
Positive affect of healthcare providers
Satisfaction with job according to selection of MAS-GZ instrument (minimum 8, maximum 40, higher score indicates higher positive affect)
Measured: Baseline, 6 months, 12 months
Experience of healthcare providers
Satisfaction with job according to selection of CO-PILOT instrument (minimum 1, maximum 10, higher score is better experience of healthcare providers)
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start29 Jan 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConditionStudies of the same condition, open and under way.
- More trials run by Radboud 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972031
- Sponsor's protocol ID
- 2022-15786
- Acronym
- EMBOSS
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBOSS: Reach and Effect of a Person-centred Integrated-care Approach for Chronic Diseases and MultimorBidity in Patients of Low sOcio- Economic StatuS in General Practice
- ClinicalTrials.gov ID
- NCT05972031
- Acronym / sponsor ID
- EMBOSS / 2022-15786
- Conditions
- Chronic Condition, Chronic Conditions, Multiple
- Keywords
- Primary care, Person-centered, Integrated-care, Health literacy, Health disparities, Socio-economic status, General practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 2 Aug 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.
People of low socio economic status (SES) more often than others suffer from chronic diseases like diabetes mellitus, chronic obstructive pulmonary disease (COPD), or coronary diseases. Compared to others People of low SES more often have to deal with multiple diseases (multimorbidity) and experience worse health outcomes. The health literacy of people of low SES is often low. Current chronic disease management programs focus on reducing the burden of a single disease by prescribing medication, protocoled monitoring routines, or lifestyle advice.
However, the effectiveness of these interventions is low in people with low SES, as the interventions insufficiently take into account the specific problems and needs of this (multimorbid) population. A person-centered and integrated-care approach, that puts the patient at the center of care instead of the disease and in which care is tailored to the individual patient with chronic disease(s), seems to be more appropriate, but only when low SES people are closely involved in the development, testing, and evaluation of such an approach. Also, certain preconditions should be met, such as training of specific knowledge and skills of the healthcare professionals involved.
In the EMBOSS project, the investigators will develop, test, evaluate, and implement a person-centered integrated-care approach for and in close collaboration with people with low SES who have one or more chronic diseases. Thus, the EMBOSS study will have the potential to reducing health disparities in this group, to broadening the action perspectives of general practitioners and practice nurses for an increasing diverse patient population and to a better fit of lifestyle interventions in people of low SES.
Detailed description
In the Netherlands, 28% of the population is lowly educated, i.e. the level of education is MBO1 (secondary vocational education) or lower, which is the main indicator of low socioeconomic status. Low-educated people suffer 2-4 times more often than high-educated people from diabetes mellitus, COPD, coronary disease (often in combination) and of the risk factors contributing to these diseases. The healthy life-expectancy for low educated people is 14 years shorter, the health outcomes are worse (more complications of cardiovascular diseases and diabetes), because of high levels of chronic stress due to challenging living circumstances, negatively influencing self-confidence and executive functions, limited health and digital literacy - all determinants of effective self-management. Most people with chronic diseases are being cared for in general practice (GP). However, professionals in GP often struggle with the care for low-educated patients, experiencing difficulties in recognizing patients with low (health) literacy, and in adapting communication and advice to the needs of this group. Low-educated patients more often visit the GP, and are more often referred to costly secondary care.
Many interventions for chronic diseases fail to show effectiveness in low-SES groups. The reasons are multiple:
- materials and procedures used are too complicated,
- daily survival sets different priorities,
- communication and approach by healthcare professionals don't suit the needs and skills of this population, actions or materials are too expensive.
Effectiveness of interventions can be improved by involving low-SES patients in the development and by training healthcare professionals. Low-educated patients should be explicitly recruited in intervention evaluation studies as this population is underrepresented in clinical studies, which impedes generalizability of results. Chronic care for patients with diabetes mellitus type 2 (DM2), COPD and/or cardiovascular diseases (CVD) in GP is carried out through disease management programmes. However, major limitations of these programmes are that it focused on a single disease, while half of the patients suffers from multimorbidity. Also, the programmes do not truly reflect the needs of patients who experience this disease management as fragmented with too little attention for the partienst personal context. Therefore, a more generic disease management (GDM) programme including a person-centred and integrated-care (PC-IC) approach seems to be a promising strategy. Such an approach puts the patient at the centre of care, tailoring chronic care to the individual's needs and addressing all the issues important to him. It starts with a comprehensive biopsychosocial assessment of all relevant problems. Subsequently, a personalised treatment plan is made with individualised goals, actions and professionals involved. The programme responds to the needs and context of the 'whole' patient to provide the right care in the right place at the right time. It supposes to stimulate patient's self-management.
Currently, in the Netherlands, some regional projects with GDM programmes and PC-IC approaches are running, of which 'OPTIMA FORMA' may be the best known. This project started in 2018 and consists of three stages in which a GDM programme including a PC-IC approach is developed, tested and evaluated in three large Dutch primary care cooperatives, i.e Nijmegen, Arnhem, and Doetinchem. However, in 'OPTIMA FORMA' as in other ongoing projects, there is no specific attention for or involvement of people with low SES. This will obviously reduce the effectiveness of this approach in low SES patients, as one third of the population with chronic diseases consists of patients with low SES. The investigators there is an urgent need for PC-IC interventions that specifically address the needs of low SES population in order to be effective. Therefore, the investigators supported the three primary care cooperatives who participate in OPTIMA FORMA with the development of a GDM programme specifically for low SES patients. With help from patients with low SES and the healthcare professionals of the low SES patient, the investigators collected information on experiences, facilitators, and barriers from the previously conducted pilot study of OPTIMA FORMA PHASE2 (CMO 2021-8106).
The investigators used this information in co-creation sessions with patients with low SES and healthcare professionals to adjust the OPTIMA FORMA programme to a GDM programme that better suits the needs of low SES patients (EMBOSS programme).
The hypothesise off the EMBOSS programme will not only result in better outcomes of care in this group (and thus decreasing socio-economic health disparities), but also to a more effective role of GPs and practice nurses with more work satisfaction and less workload. In the current study our primary research question is:
What is the effectiveness of the EMBOSS intervention, i.e. a GDM programme including a PC-IC approach developed with and for low SES people with one or more chronic diseases compared to care as usual, i.e. SDM programmes for DM2, COPD and/or CVD in general practice? The investigators will perform a cluster randomized controlled trial with a follow-up time of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Person-centred integrated care intervention | Experimental | Behavioral: Person-centred integrated care interventionThe core of the person-centered approach is a cyclical process and for EMBOSS developed for patients with low SES. The practice nurse in the GP will act as case manager and can consult other health providers. The first step in the intervention is assessing the integral health status of the patient (health across multiple domains), using a visual conversation tool. The second step is discussing the results with the patient. Personal goals are formulated in the third step. In the fourth step, the healthcare professional and patient will choose through shared-decision making the most appropriate interventions and support to achieve these goals, which are documented in a personal plan. Next, referrals are made if necessary and the treatment is started. An evaluation is planned and carried out. All practices in the EMBOSS intervention group will be trained by Pharos on how to recognize and provide GDM to low SES patients using appropriate communication skills and the specific tools. |
| Usual care | No intervention | –Practices in the control group provide care as usual, which consists of the SDM programmes according to the national care standards and General Practice guidelines (NHG) for DM2, COPD and CVD. According to these protocolised programmes, patients with COPD, CVD or DM2 visit their general practice at a standard frequency per year (1 - 4 times) and standard monitoring measurements and topics are discussed. The practices that are randomised to the control group will not receive any additional training related to this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently enrolled in any of the single disease management programmes (usual care) for DM2, COPD, asthma or CVD
Key exclusion criteria (2 listed)
- Limited life expectancy (less than 3 months)
- Patients with high level of SES (or educational level > MBO2)
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 |
|---|---|---|
| Person-centred integrated care interventionAlso: Usual careSee arm description. | Behavioural | Person-centred integrated care intervention |
Primary outcome
patient-reported health-related quality of life Physical Health
Time frame: 12 months
Global Physical Health [Time Frame: Baseline, 6 months, 12 months] Physical aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better physical aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
patient-reported health-related quality of life Mental health
Time frame: 12 months
Global Mental Health [Time Frame: Baseline, 6 months, 12 months] Mental aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better mental aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
Patient-experienced quality of care
Time frame: 12 months
atient-experienced quality of care [Time Frame: Baseline, 6 months, 12 months] Person-centredness of care as measured by the Person Centred Coordinated Care Experience Questionnaire (P3CEQ) instrument; minimum score 0, maximum score 30, higher score equals better P3CE.
9 secondary outcomes
Patient activation as measured by PAM
Time frame: Baseline, 6 months, 12 months
Health-related quality of life as measured by the EQ-5D-5L instrument
Time frame: Baseline, 6 months, 12 months
BMI
Time frame: Baseline, 6 months, 12 months
HbA1c
Time frame: Baseline, 6 months, 12 months
Blood glucose
Time frame: Baseline, 6 months, 12 months
Blood LDL-cholesterol
Time frame: Baseline, 6 months, 12 months
Systolic and diastolic blood pressure
Time frame: Baseline, 6 months, 12 months
Positive affect of healthcare providers
Time frame: Baseline, 6 months, 12 months
Experience of healthcare providers
Time frame: Baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred integrated care intervention in people with Chronic Condition and Chronic Conditions, Multiple, run by Radboud 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 1 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hester Van Bommel, MSc (+31302349800, hester.vanbommel@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported health-related quality of life Physical Health (time frame: 12 months). The study lists 3 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 6 Sep 2023.