Multiple Chronic ConditionsNCT04566107
Self-Management Interventions Using Mobile Health for the Multimorbid
A study testing mHealth intervention and mHealth Plus in people with Multiple Chronic Conditions, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Chronic Conditions
- What is being tested?
- mHealth intervention and mHealth Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 30 Jun 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- multimorbid patients with one of 4 chronic conditions (HF, COPD, diabetes or hypertension) and have at least one other chronic disease (i.e., hypertension, cancer, stroke, heart disease, diabetes, arthritis, hepatitis, current asthma, kidney failure, or COPD),
- adult patients (age 19 and older)
- access to smart technology (phone or iPad) and internet access or a phone plan large enough for daily interactions; and d) able to hear, speak and read English.
Who cannot join
- major surgery while admitted;
- discharged to somewhere other than home (e.g., long term care facility);
- receiving home health services;
- documented dementia; and
- life expectancy <6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Nursing
Lincoln, Nebraska, 68588
About this study
The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge.
Read the detailed description
The purpose of this three-group repeated-measures randomized controlled trial is to evaluate the use of mobile health (mHealth) self-management technology as a model of care for individuals with multimorbidity. Specifically, this 8-week self-management intervention uses tailored self-management strategies (action planning, goal setting, and individually identified support needs) and mHealth technology for real-time virtual visits, daily messages, and self-monitoring activities. The investigators are testing the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the mHealth platform (mHealth Plus). The NP evaluates physiological status by evaluating symptoms and tailoring the intervention specific to the individual's multimorbidity while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers.
The following specific aims will be addressed:
Aim 1: To evaluate the feasibility of implementing comparative SM interventions (mHealth and mHealth plus virtual visits with a nurse practitioner and community health worker team) in multimorbid individuals by assessing: a) acceptability of each intervention; b) enrollment (recruitment efficiency, attrition, problems and solutions); c) intervention fidelity (delivery, receipt, enactment of the intervention [benefits and barriers]); and d) data collection (technological transfer of data, instrument reliability, the time required, missing data).
Aim 2: To examine the impact of delivering the m-Health and m-Health plus interventions compared to standard care (SC) in multimorbid individuals on: a) primary outcome: adherence to disease-specific lifestyle behaviors (e.g. diet and medication, and self-monitoring of physiological measures as needed (e.g. weight blood pressure, blood glucose, oxygen saturation); b) secondary outcomes: health related quality of life; c) patient-reported health status; d) symptom status; and e) healthcare utilization.
- Conditions
- Multiple Chronic Conditions
- Being tested
- mHealth intervention, mHealth Plus
- Keywords
- multiple chronic conditions, mobile health, multimorbidity
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth interventionBehavioural
The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses mobile health (m-Health) technology for daily messages and reminders to promote self-monitoring activities. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine).
mHealth PlusBehavioural
The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses tailored self-management strategies (action planning, goal setting, and individual identified support needs) and mobile health (m-Health) technology for virtual visits, daily messages, and self-monitoring activities. The investigators will test the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the m-health platform. The NP will evaluate physiological and psychosocial status while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine). Participants will receive reminders through the platform.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | The enhanced usual care group will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, individuals in the enhanced usual care group will receive the mobile health platform to record medications taken and BlueTooth devices to record physiologic measurements. |
| mHealth | Experimental | The mHealth group will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, the mHealth group will receive the mobile health platform with reminders to take medications and engage in an educational tip. Subjects receive BlueTooth devices to record physiologic measurements. Receives: Behavioral: mHealth intervention |
| mHealth Plus | Experimental | The mHealth group plus will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, the mHealth plus group will receive the mobile health platform with reminders to take medications and engage in an educational tip. Participants receive BlueTooth devices to record physiologic measurements. The m-Health Plus group will receive real-time virtual visits with a nurse practitioner/community health worker team. Virtual visits are similar to an office follow-up visit with an health care provider using Zoom technology to allow for face-to-face interaction with the patient. Receives: Behavioral: mHealth Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool
A Usability and Acceptability investigator developed tool.
Measured: 60 days after enrolled
Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants.
measure of enrollment and recruitment
Measured: 90 days after enrolled
Number of times the participant records activities within the application.
Measurement of engagement with the application, participant records will be downloaded from the application and frequency and percent will be calculated
Measured: 90 days after enrollment
Secondary outcomes (21)
Frequency and percent of the participants recording a weight in pounds in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Measured: 30 days after intervention initiated
Frequency and percent of the participants recording a weight in pounds in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Measured: 60 days after intervention initiated
Frequency and percent of the participants recording a weight in pounds in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Measured: 90 days after intervention initiated
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Measured: 30 days after intervention initiated
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Measured: 60 days after intervention initiated
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Measured: 90 days after intervention initiated
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease. (number of oximetry readings recorded for chronic obstructive pulmonary disease (COPD) participant)
Measured: 30 days after intervention initiated
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of oximetry readings recorded for (COPD) participant)
Measured: 60 days after intervention initiated
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of oximetry readings recorded for the chronic obstructive pulmonary disease (COPD) participant)
Measured: 90 days after intervention initiated
Frequency and percent of the participants recording a blood glucose in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant)
Measured: 30 days after intervention initiated
Frequency and percent of the participants recording a blood glucose in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant)
Measured: 60 days after intervention initiated
Frequency and percent of the participants recording a blood glucose in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant)
Measured: 90 days after intervention initiated
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant)
Measured: 30 days after intervention initiated
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.
Measure of quality of life
Measured: 60 days after intervention initiated
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.
measure of quality of life
Measured: 90 days after intervention initiated
Patient Reported Outcomes Measurement Information System (PROMIS®) (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today
Measure of health status and symptoms
Measured: 30 days after intervention initiated
Patient Reported Outcomes Measurement Information System PROMIS® (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today
measure of health status and symptoms
Measured: 60 days after intervention initiated
Patient Reported Outcomes Measurement Information System PROMIS® (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today
measure of health status and symptoms
Measured: 90 days after intervention initiated
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
measure of health care utilization
Measured: 30 days after intervention initiated
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
measure of health care utilization
Measured: 60 days after intervention initiated
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
measure of health care utilization
Measured: 90 days after intervention initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start14 Oct 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Greater Plains Collaborative Clinical Data Research Network
- Responsible party
- Sponsor
- Investigators
- Myra S Schmaderer, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566107
- Sponsor's protocol ID
- 0445-18-EP
- Status last verified
- Sep 2023
- First submitted
- 4 May 2020
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Interventions Using Mobile Health for the Multimorbid
- ClinicalTrials.gov ID
- NCT04566107
- Acronym / sponsor ID
- 0445-18-EP
- Conditions
- Multiple Chronic Conditions
- Keywords
- multiple chronic conditions, mobile health, multimorbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Greater Plains Collaborative Clinical Data Research Network
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge.
Detailed description
The purpose of this three-group repeated-measures randomized controlled trial is to evaluate the use of mobile health (mHealth) self-management technology as a model of care for individuals with multimorbidity. Specifically, this 8-week self-management intervention uses tailored self-management strategies (action planning, goal setting, and individually identified support needs) and mHealth technology for real-time virtual visits, daily messages, and self-monitoring activities. The investigators are testing the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the mHealth platform (mHealth Plus). The NP evaluates physiological status by evaluating symptoms and tailoring the intervention specific to the individual's multimorbidity while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers.
The following specific aims will be addressed:
Aim 1: To evaluate the feasibility of implementing comparative SM interventions (mHealth and mHealth plus virtual visits with a nurse practitioner and community health worker team) in multimorbid individuals by assessing: a) acceptability of each intervention; b) enrollment (recruitment efficiency, attrition, problems and solutions); c) intervention fidelity (delivery, receipt, enactment of the intervention [benefits and barriers]); and d) data collection (technological transfer of data, instrument reliability, the time required, missing data).
Aim 2: To examine the impact of delivering the m-Health and m-Health plus interventions compared to standard care (SC) in multimorbid individuals on: a) primary outcome: adherence to disease-specific lifestyle behaviors (e.g. diet and medication, and self-monitoring of physiological measures as needed (e.g. weight blood pressure, blood glucose, oxygen saturation); b) secondary outcomes: health related quality of life; c) patient-reported health status; d) symptom status; and e) healthcare utilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No intervention | –The enhanced usual care group will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, individuals in the enhanced usual care group will receive the mobile health platform to record medications taken and BlueTooth devices to record physiologic measurements. |
| mHealth | Experimental | Behavioral: mHealth interventionThe mHealth group will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, the mHealth group will receive the mobile health platform with reminders to take medications and engage in an educational tip. Subjects receive BlueTooth devices to record physiologic measurements. |
| mHealth Plus | Experimental | Behavioral: mHealth PlusThe mHealth group plus will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, the mHealth plus group will receive the mobile health platform with reminders to take medications and engage in an educational tip. Participants receive BlueTooth devices to record physiologic measurements. The m-Health Plus group will receive real-time virtual visits with a nurse practitioner/community health worker team. Virtual visits are similar to an office follow-up visit with an health care provider using Zoom technology to allow for face-to-face interaction with the patient. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- multimorbid patients with one of 4 chronic conditions (HF, COPD, diabetes or hypertension) and have at least one other chronic disease (i.e., hypertension, cancer, stroke, heart disease, diabetes, arthritis, hepatitis, current asthma, kidney failure, or COPD),
- adult patients (age 19 and older)
- access to smart technology (phone or iPad) and internet access or a phone plan large enough for daily interactions; and d) able to hear, speak and read English.
Key exclusion criteria (5 listed)
- major surgery while admitted;
- discharged to somewhere other than home (e.g., long term care facility);
- receiving home health services;
- documented dementia; and
- life expectancy <6 months.
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 |
|---|---|---|
| mHealth interventionThe intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses mobile health (m-Health) technology for daily messages and reminders to promote self-monitoring activities. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine). | Behavioural | mHealth |
| mHealth PlusThe intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses tailored self-management strategies (action planning, goal setting, and individual identified support needs) and mobile health (m-Health) technology for virtual visits, daily messages, and self-monitoring activities. The investigators will test the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the m-health platform. The NP will evaluate physiological and psychosocial status while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine). Participants will receive reminders through the platform. | Behavioural | mHealth Plus |
Primary outcome
Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool
Time frame: 60 days after enrolled
A Usability and Acceptability investigator developed tool.
Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants.
Time frame: 90 days after enrolled
measure of enrollment and recruitment
Number of times the participant records activities within the application.
Time frame: 90 days after enrollment
Measurement of engagement with the application, participant records will be downloaded from the application and frequency and percent will be calculated
21 secondary outcomes
Frequency and percent of the participants recording a weight in pounds in the mHealth app
Time frame: 30 days after intervention initiated
Frequency and percent of the participants recording a weight in pounds in the mHealth app
Time frame: 60 days after intervention initiated
Frequency and percent of the participants recording a weight in pounds in the mHealth app
Time frame: 90 days after intervention initiated
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
Time frame: 30 days after intervention initiated
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
Time frame: 60 days after intervention initiated
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
Time frame: 90 days after intervention initiated
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
Time frame: 30 days after intervention initiated
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
Time frame: 60 days after intervention initiated
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
Time frame: 90 days after intervention initiated
Frequency and percent of the participants recording a blood glucose in the mHealth app
Time frame: 30 days after intervention initiated
Frequency and percent of the participants recording a blood glucose in the mHealth app
Time frame: 60 days after intervention initiated
Frequency and percent of the participants recording a blood glucose in the mHealth app
Time frame: 90 days after intervention initiated
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.
Time frame: 30 days after intervention initiated
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.
Time frame: 60 days after intervention initiated
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.
Time frame: 90 days after intervention initiated
Patient Reported Outcomes Measurement Information System (PROMIS®) (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today
Time frame: 30 days after intervention initiated
Patient Reported Outcomes Measurement Information System PROMIS® (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today
Time frame: 60 days after intervention initiated
Patient Reported Outcomes Measurement Information System PROMIS® (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today
Time frame: 90 days after intervention initiated
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
Time frame: 30 days after intervention initiated
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
Time frame: 60 days after intervention initiated
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
Time frame: 90 days after intervention initiated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Myra S Schmaderer, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth intervention and mHealth Plus in people with Multiple Chronic Conditions, run by University of Nebraska at 1 site in United States.
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: finished, as of the sponsor's last update on 26 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool (time frame: 60 days after enrolled). 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 26 Sep 2023.