Health Care UtilizationHOLISTICNCT04250103
Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care
An observational study of Health Care Utilization and Caregiver Burnout, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization, Caregiver Burnout
- How many people
- 1,200 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2019to 31 Dec 2022
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with home health care and their caregivers
Who may be able to join
- Aged 20 years or older
- Receiving home health care services at least two months
- Either the patient or caregiver can express clearly
Who cannot join
- Reject to sign the informed consent
- Both the patient and caregiver cannot complete the interview
- Both the patient and caregiver cannot communicate with an interviewer in a familiar language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care
Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs. However, little was known about the longitudinal change of comprehensive assessments of physical and mental health, QoL, well-being, and medical resource utilization of patients receiving home health care and their caregivers. Furthermore, the evaluation of advance care planning, palliative care need, and the quality of dying and death were also insufficient among the aforementioned population. Therefore, this cohort study aims to investigate the longitudinal change of health-related outcomes and utilization of resource utilization, and explore their trajectories in two years for patients who receive home health care and their caregivers in Taiwan.
Read the detailed description
This is a prospective longitudinal cohort study in Taiwan. Data will be collected by trained interviewers at the baseline (T0), 3-month follow-up (T1), 6-month follow-up (T2), 12-month follow-up (T3), 18-month follow-up (T4), and 24-month follow-up (T5). Via home visits, interviewer-administered questionnaires (informed consent, contact/follow-up information, background information, health condition, physical functioning, cognitive function, etc.) will be used. It estimates that the home visit will take up to 2 hours.
The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.
In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.
- Conditions
- Health Care Utilization, Caregiver Burnout
- Keywords
- Home health care, Super-aged society
- Medical subject headings
- Patient Acceptance of Health Care, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient | patients who receive home health care | |
| caregiver | caregivers who take care of patients with home health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from ability to perform activities of daily living (ADL) at two years
The Barthel Index will be adapted to assess ADL. The total score ranges from 0 to 100, with 100 indicating full independence in doing daily activities.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from frailty at two years
It will be measured by the 9-point Clinical Frailty Scale (CFS). The total score ranges from 1 to 9, with 7 or higher indicating severe frailty, even being terminally ill.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from cognitive function/memory at two years
It will be measured by the Brain Health Test (Chinese version) via testing the orientation to time, immediate and delayed recall of five items, categorical verbal fluency test. The total score ranges from 0 to 16, with higher scores indicating worse cognitive impairment.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from percentage of participants with Dementia at two years
The Functional Assessment Staging Test (FAST) will be adapted to assess an individual's stage of Alzheimer's disease. It includes seven stages from normal aging to sever Dementia.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from mean score of depression at two years
It will be measured by the 5-item Geriatric Depression Scale (GDS). The total score ranges from 0 to 5, with higher scores indicating more depression.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from neuropsychiatric status at two years
It will be measured by the Neuropsychiatric Inventory. The 10 sub-domains of behavioral functioning are examined, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity syndrome.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from quality of life (QOL) at two years
We will adapt the Quality of Life in Alzheimer's Disease (QOL-AD) scale for patients with cognitive impairment, and Quality of Life Survey for Home Care (QOL-HC) scale for those without cognitive impairment. The total score of QOL-AD ranges from 13 to 52, with higher values indicating a higher QoL. The total score of QOL-HC ranges from 0 to 8, with higher values indicating a higher QoL.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from mental wellbeing at two years
It will be measured by the World Health Organization- Five Well-Being Index (WHO-5). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Shared decision making (SDM)
It will be measured by the Decision-making Participation Self-Efficacy Scale (DEPS). The total score ranges from 5 to 25, with higher scores indicating higher self-efficacy.
Measured: Two years
Advance Care Planning (ACP)
It will be measured by the 4-question version of UCSF-ACP with the Process Measures (knowledge, contemplation, self-efficacy, and readiness, 5-point Likert scales) and Action Measures (yes/no whether an ACP behavior is completed).
Measured: Two years
Change from Nutrition status at two years
It will include the Mini Nutritional Assessment (MNA). The total score of MNA ranges from 0-14, with more than 11 indicating normal nutrition status.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from risk for pressure injury at two years
It will be measured by the sale of Braden Scale for Predicting Pressure Sore Risk. The scale is composed of six subscales that reflect sensory perception, skin moisture, activity, mobility, friction and shear, and nutritional status. The total score ranges from 6 to 23, with higher scores indicating lower risk for forming pressure sores.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Needs assessment for supportive & palliative care
It will be measured by the Supportive \& Palliative Care Indicators Tool (SPICT). Following the guideline, the Chinese version will be developed before the cohort study starts.
Measured: Two years
Change from medical resource utilization at two years
Assessments include medical costs and out-of-pocket costs regarding utilization of medical resource and home health care. The used scales are developed by our research team.
Measured: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
Change from caregiving burden at two years
It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Change from number of used chronic disease drug at two years
It will be measured by two items which are developed by our research team. Based on patients' prescriptions, they will be required to answer the number of chronic disease drug they used and these drugs' information, including the names, administrations and dosages.
Measured: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start20 Nov 2019
- Primary completion20 Nov 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Society of Home Health Care
- Responsible party
- Principal investigator, Chao A. Hsiung, National Health Research Institutes, Taiwan
- Investigators
- Chao A. Hsiung, PhD, Study director, National Health Research Institutes, TaiwanSang-Ju Yu, MD, Principal investigator, Taiwan Society of Home Health Care and Home Clinic DulanPing-Jen Chen, MD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250103
- Sponsor's protocol ID
- EC1080203
- Acronym
- HOLISTIC
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin CP, Liao JY, Huang CH, Cheng SY, Tseng WZ, Mori M, Chang HC, Li CM, Sun WJ, Wu CY, Chiou HY, Yu SJ, Hsiung CA, Chen PJ; HOLISTIC Investigators. Association Between Current Medical Decision-Making Participation Self-Efficacy and Advance Care Planning Engagement Among Older Adults: Baseline Findings from a Nationwide Longitudinal Cohort Study. J Palliat Med. 2025 Jan;28(1):50-58. doi: 10.1089/jpm.2024.0106. Epub 2024 Dec 5.
PubMed 39636682Lai YC, Tsai KT, Ho CH, Liao JY, Tseng WZ, Petersen I, Wang YC, Chen YH, Chiou HY, Hsiung CA, Yu SJ, Sampson EL, Chen PJ. Mortality rate and its determinants among people with dementia receiving home healthcare: a nationwide cohort study. Intern Emerg Med. 2023 Oct;18(7):2121-2130. doi: 10.1007/s11739-023-03319-3. Epub 2023 May 30.
PubMed 37253992Liao JY, Chen PJ, Wu YL, Cheng CH, Yu SJ, Huang CH, Li CM, Wang YW, Zhang KP, Liu IT, Umegaki H, Hamano J, Mori M, Petersen I, Sampson EL, Hsiung CA. HOme-based Longitudinal Investigation of the multidiSciplinary Team Integrated Care (HOLISTIC): protocol of a prospective nationwide cohort study. BMC Geriatr. 2020 Nov 27;20(1):511. doi: 10.1186/s12877-020-01920-1.
PubMed 33246407
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care
- ClinicalTrials.gov ID
- NCT04250103
- Acronym / sponsor ID
- HOLISTIC / EC1080203
- Conditions
- Health Care Utilization, Caregiver Burnout
- Keywords
- Home health care, Super-aged society
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taiwan Society of Home Health Care
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Jan 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.
Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs. However, little was known about the longitudinal change of comprehensive assessments of physical and mental health, QoL, well-being, and medical resource utilization of patients receiving home health care and their caregivers. Furthermore, the evaluation of advance care planning, palliative care need, and the quality of dying and death were also insufficient among the aforementioned population. Therefore, this cohort study aims to investigate the longitudinal change of health-related outcomes and utilization of resource utilization, and explore their trajectories in two years for patients who receive home health care and their caregivers in Taiwan.
Detailed description
This is a prospective longitudinal cohort study in Taiwan. Data will be collected by trained interviewers at the baseline (T0), 3-month follow-up (T1), 6-month follow-up (T2), 12-month follow-up (T3), 18-month follow-up (T4), and 24-month follow-up (T5). Via home visits, interviewer-administered questionnaires (informed consent, contact/follow-up information, background information, health condition, physical functioning, cognitive function, etc.) will be used. It estimates that the home visit will take up to 2 hours.
The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.
In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | –patients who receive home health care |
| caregiver | – | –caregivers who take care of patients with home health care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with home health care and their caregivers
Key inclusion criteria (3 listed)
- Aged 20 years or older
- Receiving home health care services at least two months
- Either the patient or caregiver can express clearly
Key exclusion criteria (3 listed)
- Reject to sign the informed consent
- Both the patient and caregiver cannot complete the interview
- Both the patient and caregiver cannot communicate with an interviewer in a familiar language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from ability to perform activities of daily living (ADL) at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
The Barthel Index will be adapted to assess ADL. The total score ranges from 0 to 100, with 100 indicating full independence in doing daily activities.
Change from frailty at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the 9-point Clinical Frailty Scale (CFS). The total score ranges from 1 to 9, with 7 or higher indicating severe frailty, even being terminally ill.
Change from cognitive function/memory at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the Brain Health Test (Chinese version) via testing the orientation to time, immediate and delayed recall of five items, categorical verbal fluency test. The total score ranges from 0 to 16, with higher scores indicating worse cognitive impairment.
Change from percentage of participants with Dementia at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
The Functional Assessment Staging Test (FAST) will be adapted to assess an individual's stage of Alzheimer's disease. It includes seven stages from normal aging to sever Dementia.
Change from mean score of depression at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the 5-item Geriatric Depression Scale (GDS). The total score ranges from 0 to 5, with higher scores indicating more depression.
Change from neuropsychiatric status at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the Neuropsychiatric Inventory. The 10 sub-domains of behavioral functioning are examined, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity syndrome.
Change from quality of life (QOL) at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
We will adapt the Quality of Life in Alzheimer's Disease (QOL-AD) scale for patients with cognitive impairment, and Quality of Life Survey for Home Care (QOL-HC) scale for those without cognitive impairment. The total score of QOL-AD ranges from 13 to 52, with higher values indicating a higher QoL. The total score of QOL-HC ranges from 0 to 8, with higher values indicating a higher QoL.
Change from mental wellbeing at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the World Health Organization- Five Well-Being Index (WHO-5). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Shared decision making (SDM)
Time frame: Two years
It will be measured by the Decision-making Participation Self-Efficacy Scale (DEPS). The total score ranges from 5 to 25, with higher scores indicating higher self-efficacy.
Advance Care Planning (ACP)
Time frame: Two years
It will be measured by the 4-question version of UCSF-ACP with the Process Measures (knowledge, contemplation, self-efficacy, and readiness, 5-point Likert scales) and Action Measures (yes/no whether an ACP behavior is completed).
Change from Nutrition status at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will include the Mini Nutritional Assessment (MNA). The total score of MNA ranges from 0-14, with more than 11 indicating normal nutrition status.
Change from risk for pressure injury at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the sale of Braden Scale for Predicting Pressure Sore Risk. The scale is composed of six subscales that reflect sensory perception, skin moisture, activity, mobility, friction and shear, and nutritional status. The total score ranges from 6 to 23, with higher scores indicating lower risk for forming pressure sores.
Needs assessment for supportive & palliative care
Time frame: Two years
It will be measured by the Supportive \& Palliative Care Indicators Tool (SPICT). Following the guideline, the Chinese version will be developed before the cohort study starts.
Change from medical resource utilization at two years
Time frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
Assessments include medical costs and out-of-pocket costs regarding utilization of medical resource and home health care. The used scales are developed by our research team.
Change from caregiving burden at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden.
Change from number of used chronic disease drug at two years
Time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
It will be measured by two items which are developed by our research team. Based on patients' prescriptions, they will be required to answer the number of chronic disease drug they used and these drugs' information, including the names, administrations and dosages.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 39636682Lin CP, Liao JY, Huang CH, Cheng SY, Tseng WZ, Mori M, Chang HC, Li CM, Sun WJ, Wu CY, Chiou HY, Yu SJ, Hsiung CA, Chen PJ; HOLISTIC Investigators. Association Between Current Medical Decision-Making Participation Self-Efficacy and Advance Care Planning Engagement Among Older Adults: Baseline Findings from a Nationwide Longitudinal Cohort Study. J Palliat Med. 2025 Jan;28(1):50-58. doi: 10.1089/jpm.2024.0106. Epub 2024 Dec 5.
- Derived from this study: PubMed 37253992Lai YC, Tsai KT, Ho CH, Liao JY, Tseng WZ, Petersen I, Wang YC, Chen YH, Chiou HY, Hsiung CA, Yu SJ, Sampson EL, Chen PJ. Mortality rate and its determinants among people with dementia receiving home healthcare: a nationwide cohort study. Intern Emerg Med. 2023 Oct;18(7):2121-2130. doi: 10.1007/s11739-023-03319-3. Epub 2023 May 30.
- Derived from this study: PubMed 33246407Liao JY, Chen PJ, Wu YL, Cheng CH, Yu SJ, Huang CH, Li CM, Wang YW, Zhang KP, Liu IT, Umegaki H, Hamano J, Mori M, Petersen I, Sampson EL, Hsiung CA. HOme-based Longitudinal Investigation of the multidiSciplinary Team Integrated Care (HOLISTIC): protocol of a prospective nationwide cohort study. BMC Geriatr. 2020 Nov 27;20(1):511. doi: 10.1186/s12877-020-01920-1.
- 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.
Chao A. Hsiung, PhD study director
National Health Research Institutes, Taiwan
Sang-Ju Yu, MD principal investigator
Taiwan Society of Home Health Care and Home Clinic Dulan
Ping-Jen Chen, MD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Utilization and Caregiver Burnout, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. 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 Taiwan. 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?
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?
Change from ability to perform activities of daily living (ADL) at two years (time frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up). The study lists 16 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 NCT04250103, which also lists 3 linked publications.
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 31 Jan 2020.