Dementia, Alzheimer TypeI-CARENCT03119259
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
A study testing ABC Clinical Program and BCN in people with Dementia, Alzheimer Type, run by Indiana University at 2 sites in United States.
Trial summary
The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN on reducing informal caregiver burden at 6 months, and 3) To estimate the effect size of BCN on reducing patient behavioral and psychological symptoms of dementia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Alzheimer Type
- What is being tested?
- ABC Clinical Program and BCN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Nov 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient has received a diagnosis of possible or probable Alzheimer's disease and Related Dementia from a physician in the ABC Clinical Program;
- Caregiver is at least 18 years of age and does not have a visual impairment significant enough to interfere with his/her ability to use BCN;
- Both patient and caregiver are community-dwelling in central Indiana; and
- Both patient and caregiver are willing to participate in the ABC Clinical Program (including receiving home visits).
Who cannot join
- Either the patient or his/her informal caregiver does not have the ability to communicate in English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
IU Health
Indianapolis, Indiana, 46202
About this study
The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN on reducing informal caregiver burden at 6 months, and 3) To estimate the effect size of BCN on reducing patient behavioral and psychological symptoms of dementia (BPSD) at 6 months. Subjects will be recruited from the Aging Brain Care (ABC) program of Eskenazi Health and Indiana University Health located in central Indiana.
Read the detailed description
Informal caregivers of patients with Alzheimer's disease and related dementia (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). BPSD are major contributing factors to caregivers' burden and adverse health outcomes, leading to an increase of unplanned hospitalizations and a decrease in quality of life. The National Alzheimer's Project Act recognizes the need for interventions that "enable family caregivers to continue to provide care while maintaining their own health and well-being." Furthermore, recommendations from 2015 and 2018 Alzheimer's Disease Research Summits include the application of technology to improve caregiving research and ADRD care
This pilot randomized controlled trial, will test the feasibility and estimate the effect size of integrating mobile health technology BrainCare Notes (BCN) into an existing, fully operational, and self-sustaining clinical program (Aging Brain Care; ABC) and IU Health primary care physician clinics (IUHP). BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementia (ADRD). The BCN app delivers 24/7 psychoeducation and caregiver support, assessment of informal caregiver status and patients' behavioral and psychological symptoms of dementia (BPSD), and engagement tools for self-management and communication. Over a 15 month accrual period, we propose to enroll from the ABC clinical program and IUHP 60 dyads consisting of an adult patient with ADRD and one (primary) informal caregiver. The intervention will continue for 6 months and final assessments will be completed at 6 months. Feasibility data will be collected throughout the study and assessed at the end of the study by computing: (a) recruitment rate; (b) data completion; (c) BCN usability; (d) BCN acceptance; and (e) BCN use. Caregiver burden and patient BPSD will be collected at baseline, 3, and 6 months and evaluated for changes from baseline to 6 months in each group. Means, standard deviations, and confidence intervals will be computed to test feasibility hypotheses. Mixed linear models will be used to test hypotheses comparing the two conditions at 6 months.
- Conditions
- Dementia, Alzheimer Type
- Being tested
- ABC Clinical Program, BCN
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC Clinical ProgramBehavioural
Also called IUHP Usual Care
The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. The ABC Clinical Program is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.
The goal of IUHP Usual Care is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and refered to brain care specialty as necessary.
BCNBehavioural
BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementias (ADRD). The BCN app delivers the following behavioral support:
- 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
- Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
- Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
| Study group | Role | What they receive |
|---|---|---|
| ABC Clinical Program Only and Usual Care | Active comparator | Patients and informal caregivers randomized to the comparison group will receive care provided by the ABC Clinical Program and IUHP. The ABC Clinical Program is the standard of ADRD care at Eskenazi Health and Primary Care Visits at Indiana University Health is the usual care. Receives: Behavioral: ABC Clinical Program |
| BCN Mobile App Plus ABC and BCN Mobile app only | Experimental | Patients and caregivers randomized to the intervention group will continue to receive care in ABC clinical program and IUHP, and have the BCN software installed on either the caregiver's personal mobile device (assuming it meets minimal technical requirements) or a device provided by the study, per participant preference. A research assistant will orient participants to the device, provide training on the BCN software, and troubleshoot technical issues. Participants will receive daytime technical support by phone, electronic support request through a separate app, or printed and in-app help manuals. Hardware, software, and connectivity check-ups will be provided by study research personnel. Receives: Behavioral: ABC Clinical Program; Behavioral: BCN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
Measured: 15 month accrual period
Feasibility: Data Completeness
Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.
Measured: 6 months after enrollment and randomization
Feasibility: BCN Usability (3 Months)
BCN usability at 3 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 (worst outcome) to 100 (best outcome).
Measured: 3 months
Feasibility: BCN Usability (6 Months)
BCN usability at 6 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 to 100. Higher scores indicate higher usability.
Measured: 6 months
Feasibility: BCN Acceptance (3 Months)
Acceptance at 3 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal). Higher scores indicate higher acceptance.
Measured: 3 months
Feasibility: BCN Acceptance (6 Months)
Acceptance at 6 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal).
Measured: 6 months
Secondary outcomes (8)
Caregiver Burden (Baseline)
Informal caregiver burden at baseline, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
Measured: baseline
Caregiver Burden (3 Months)
Informal caregiver burden at 3 months, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
Measured: 3 months
Caregiver Burden (6 Months)
Informal caregiver burden at 6 months, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
Measured: 6 months
BPSD Severity (Baseline)
Severity of patient behavioral and psychological symptoms of dementia (BPSD) at baseline, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
Measured: baseline
BPSD Severity (3 Months)
Severity of patient behavioral and psychological symptoms of dementia (BPSD) at 3 months, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
Measured: 3 months
BPSD Severity (6 Months)
Severity of patient behavioral and psychological symptoms of dementia (BPSD) at 6 months, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
Measured: 6 months
Acute Care Utilization (3 Months)
Number of all-cause hospital and emergency room admissions among patients and caregivers in the first 3 months (3 months post-intervention).
Measured: 3 months
Acute Care Utilization (6 Months)
Number of all-cause hospital and emergency room admissions among patients and caregivers in the last 3 months (at 6 months post-intervention).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start25 Nov 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, Alzheimer TypeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Richard Holden, Indiana University
- Investigators
- Richard J. Holden, PhD, Principal investigator, Indiana UniversityMalaz Boustani, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119259
- Sponsor's protocol ID
- 1606267154
- Other IDs
- R21AG062966
- Acronym
- I-CARE
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data, or results, will be shared through traditional mechanisms such as peer-reviewed journals and presentations at national meetings. The Enhanced Medical Record - Aging Brain Care (eMR-ABC), the dedicated electronic medical record for the Aging Brain Care (ABC) Clinical Program, was developed with the intent of sharing de-identified data with the scientific community. The Indiana Network for Patient Care (INPC) is a state-wide health information exchange. INPC data is collected for patient care purposes and is not "owned" by Indiana University or the Regenstrief Institute, Inc. - each participating health care system or program retains ownership of their data. At present, Indiana University/Regenstrief Institute scientists do not have the direct authority to share even de-identified patient data. Therefore, any request to use these data for research purposes must be adjudicated on a case-by-case basis.
Publications
Braly T, Muriathiri D, Brown JC, Taylor BM, Boustani MA, Holden RJ. Technology intervention to support caregiving for Alzheimer's disease (I-CARE): study protocol for a randomized controlled pilot trial. Pilot Feasibility Stud. 2021 Jan 11;7(1):23. doi: 10.1186/s40814-020-00755-2.
PubMed 33431027
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
- ClinicalTrials.gov ID
- NCT03119259
- Acronym / sponsor ID
- I-CARE / 1606267154
- Conditions
- Dementia, Alzheimer Type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN on reducing informal caregiver burden at 6 months, and 3) To estimate the effect size of BCN on reducing patient behavioral and psychological symptoms of dementia (BPSD) at 6 months. Subjects will be recruited from the Aging Brain Care (ABC) program of Eskenazi Health and Indiana University Health located in central Indiana.
Detailed description
Informal caregivers of patients with Alzheimer's disease and related dementia (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). BPSD are major contributing factors to caregivers' burden and adverse health outcomes, leading to an increase of unplanned hospitalizations and a decrease in quality of life. The National Alzheimer's Project Act recognizes the need for interventions that "enable family caregivers to continue to provide care while maintaining their own health and well-being." Furthermore, recommendations from 2015 and 2018 Alzheimer's Disease Research Summits include the application of technology to improve caregiving research and ADRD care
This pilot randomized controlled trial, will test the feasibility and estimate the effect size of integrating mobile health technology BrainCare Notes (BCN) into an existing, fully operational, and self-sustaining clinical program (Aging Brain Care; ABC) and IU Health primary care physician clinics (IUHP). BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementia (ADRD). The BCN app delivers 24/7 psychoeducation and caregiver support, assessment of informal caregiver status and patients' behavioral and psychological symptoms of dementia (BPSD), and engagement tools for self-management and communication. Over a 15 month accrual period, we propose to enroll from the ABC clinical program and IUHP 60 dyads consisting of an adult patient with ADRD and one (primary) informal caregiver. The intervention will continue for 6 months and final assessments will be completed at 6 months. Feasibility data will be collected throughout the study and assessed at the end of the study by computing: (a) recruitment rate; (b) data completion; (c) BCN usability; (d) BCN acceptance; and (e) BCN use. Caregiver burden and patient BPSD will be collected at baseline, 3, and 6 months and evaluated for changes from baseline to 6 months in each group. Means, standard deviations, and confidence intervals will be computed to test feasibility hypotheses. Mixed linear models will be used to test hypotheses comparing the two conditions at 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABC Clinical Program Only and Usual Care | Active comparator | Behavioral: ABC Clinical ProgramPatients and informal caregivers randomized to the comparison group will receive care provided by the ABC Clinical Program and IUHP. The ABC Clinical Program is the standard of ADRD care at Eskenazi Health and Primary Care Visits at Indiana University Health is the usual care. |
| BCN Mobile App Plus ABC and BCN Mobile app only | Experimental | Behavioral: ABC Clinical Program, Behavioral: BCNPatients and caregivers randomized to the intervention group will continue to receive care in ABC clinical program and IUHP, and have the BCN software installed on either the caregiver's personal mobile device (assuming it meets minimal technical requirements) or a device provided by the study, per participant preference. A research assistant will orient participants to the device, provide training on the BCN software, and troubleshoot technical issues. Participants will receive daytime technical support by phone, electronic support request through a separate app, or printed and in-app help manuals. Hardware, software, and connectivity check-ups will be provided by study research personnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has received a diagnosis of possible or probable Alzheimer's disease and Related Dementia from a physician in the ABC Clinical Program;
- Caregiver is at least 18 years of age and does not have a visual impairment significant enough to interfere with his/her ability to use BCN;
- Both patient and caregiver are community-dwelling in central Indiana; and
- Both patient and caregiver are willing to participate in the ABC Clinical Program (including receiving home visits).
Key exclusion criteria (1 listed)
- Either the patient or his/her informal caregiver does not have the ability to communicate in English.
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 |
|---|---|---|
| ABC Clinical ProgramAlso: IUHP Usual CareThe goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. The ABC Clinical Program is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan. The goal of IUHP Usual Care is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and refered to brain care specialty as necessary. | Behavioural | ABC Clinical Program Only and Usual Care, BCN Mobile App Plus ABC and BCN Mobile app only |
| BCNBCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementias (ADRD). The BCN app delivers the following behavioral support: 1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes"; 2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores; 3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others. | Behavioural | BCN Mobile App Plus ABC and BCN Mobile app only |
Primary outcome
Feasibility: Recruitment Rate
Time frame: 15 month accrual period
Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
Feasibility: Data Completeness
Time frame: 6 months after enrollment and randomization
Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.
Feasibility: BCN Usability (3 Months)
Time frame: 3 months
BCN usability at 3 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 (worst outcome) to 100 (best outcome).
Feasibility: BCN Usability (6 Months)
Time frame: 6 months
BCN usability at 6 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 to 100. Higher scores indicate higher usability.
Feasibility: BCN Acceptance (3 Months)
Time frame: 3 months
Acceptance at 3 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal). Higher scores indicate higher acceptance.
Feasibility: BCN Acceptance (6 Months)
Time frame: 6 months
Acceptance at 6 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal).
8 secondary outcomes
Caregiver Burden (Baseline)
Time frame: baseline
Caregiver Burden (3 Months)
Time frame: 3 months
Caregiver Burden (6 Months)
Time frame: 6 months
BPSD Severity (Baseline)
Time frame: baseline
BPSD Severity (3 Months)
Time frame: 3 months
BPSD Severity (6 Months)
Time frame: 6 months
Acute Care Utilization (3 Months)
Time frame: 3 months
Acute Care Utilization (6 Months)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33431027Braly T, Muriathiri D, Brown JC, Taylor BM, Boustani MA, Holden RJ. Technology intervention to support caregiving for Alzheimer's disease (I-CARE): study protocol for a randomized controlled pilot trial. Pilot Feasibility Stud. 2021 Jan 11;7(1):23. doi: 10.1186/s40814-020-00755-2.
- Individual participant dataSharing planned: Yes. Data, or results, will be shared through traditional mechanisms such as peer-reviewed journals and presentations at national meetings. The Enhanced Medical Record - Aging Brain Care (eMR-ABC), the dedicated electronic medical record for the Aging Brain Care (ABC) Clinical Program, was developed with the intent of sharing de-identified data with the scientific community. The Indiana Network for Patient Care (INPC) is a state-wide health information exchange. INPC data is collected for patient care purposes and is not "owned" by Indiana University or the Regenstrief Institute, Inc. - each participating health care system or program retains ownership of their data. At present, Indiana University/Regenstrief Institute scientists do not have the direct authority to share even de-identified patient data. Therefore, any request to use these data for research purposes must be adjudicated on a case-by-case basis.
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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.
Richard J. Holden, PhD principal investigator
Indiana University
Malaz Boustani, MD, MPH principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABC Clinical Program and BCN in people with Dementia, Alzheimer Type, run by Indiana University at 2 sites 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 4 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility: Recruitment Rate (time frame: 15 month accrual period). The study lists 6 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 NCT03119259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.