DementiaNCT04206670
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
A study testing In-Home Technology System and Questionnaires in people with Dementia and Mild Cognitive Impairment, run by University of California, Berkeley at 1 site in United States.
Trial summary
This study aims to develop and evaluate new in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease, other dementias, or mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- In-Home Technology System and Questionnaires
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 8 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers are fluent/literate in English
- Caregivers currently reside with spouse/family member who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment
- Caregivers primarily use a smartphone (e.g., iPhone, Android)
- Caregiver has wireless internet in home
Who cannot join
- Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition
- Caregivers providing care for individuals with longstanding Axis I psychiatric disorder
- Caregivers providing care for individuals with metabolic disorder or major organ dysfunction
- Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)
- Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes
- Caregivers providing care for individuals with contraindications to MRI imaging
Show all 9Show fewer
- Caregivers providing care for individuals with large confluent white matter lesions
- Caregivers providing care for individuals with significant systemic medical illness
- Caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
Official title: Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
This study aims to develop and evaluate new in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease, other dementias, or mild cognitive impairment.
Read the detailed description
This study aims to develop, refine, and evaluate a new hardware/software system designed to integrate in-home sensors and devices, Internet-of-Things technologies (i.e., devices that can be controlled and communicated with via the internet), and social networking to create a more safe and supportive home environment for caregivers and people who have Alzheimer's disease, other dementias, or mild cognitive impairment. The system monitors troublesome behaviors in people with dementia or mild cognitive impairment (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia or mild cognitive impairment with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.
Hypotheses:
- Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control condition.
- Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
- Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.
- Conditions
- Dementia, Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- In-Home Technology System and Questionnaires, Waiting Control In-Home Technology System and Questionnaires
- Keywords
- Caregivers, Dementia, Mild Cognitive Impairment, In-Home Technology, Alzheimer Disease
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Home Technology System and QuestionnairesDevice
Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
Waiting Control In-Home Technology System and QuestionnairesDevice
Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
| Study group | Role | What they receive |
|---|---|---|
| In-Home Technology System | Experimental | Participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter). Receives: Device: In-Home Technology System and Questionnaires |
| Waiting Control | Other | Participants will be assigned a date for receiving and installing the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) six months after they enter the study. During that six-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). At the end of the six-month period, participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional six-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation). Receives: Device: Waiting Control In-Home Technology System and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
Measured: 3 months after baseline
6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
Measured: 6 months after baseline
3 Months Assessment for Zarit Burden Interview-Short Form
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
Measured: 3 months after baseline
6 Months Assessment for Zarit Burden Interview-Short Form
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
Measured: 6 months after baseline
3 Months Assessment for Beck Anxiety Inventory (BAI)
Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
Measured: 3 months after baseline
6 Months Assessment for Beck Anxiety Inventory (BAI)
Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
Measured: 6 months after baseline
3 Months Assessment for Satisfaction With Life Scale
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
Measured: 3 months after baseline
6 Months Assessment for Satisfaction With Life Scale
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start10 Mar 2020
- Primary completion8 Dec 2021
- Study completion8 Dec 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 (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- People Power Company, National Institute on Aging (NIA), University of California, San Francisco
- Responsible party
- Principal investigator, Robert Levenson, University of California, Berkeley
- Investigators
- Robert W Levenson, Ph.D., Study director, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206670
- Sponsor's protocol ID
- R44AG059458-03
- Other IDs
- R44AG059458
- Status last verified
- Apr 2022
- First submitted
- 10 Dec 2019
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because health and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.
Publications
Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.
PubMed 29216633Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.
PubMed 28655841Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.
PubMed 28395276Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.
PubMed 29289452Bullard BM, Brown CL, Scheffer JA, Toledo AB, Levenson RW. Emotion Regulation Strategies and Mental Health in Dementia Caregivers: The Moderating Role of Gender. Dement Geriatr Cogn Disord. 2024;53(3):128-134. doi: 10.1159/000538398. Epub 2024 Apr 22.
PubMed 38537622
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04206670
- Acronym / sponsor ID
- R44AG059458-03
- Conditions
- Dementia, Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Caregivers, Dementia, Mild Cognitive Impairment, In-Home Technology, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- People Power Company, National Institute on Aging (NIA), University of California, San Francisco
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate new in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease, other dementias, or mild cognitive impairment.
Detailed description
This study aims to develop, refine, and evaluate a new hardware/software system designed to integrate in-home sensors and devices, Internet-of-Things technologies (i.e., devices that can be controlled and communicated with via the internet), and social networking to create a more safe and supportive home environment for caregivers and people who have Alzheimer's disease, other dementias, or mild cognitive impairment. The system monitors troublesome behaviors in people with dementia or mild cognitive impairment (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia or mild cognitive impairment with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.
Hypotheses:
- Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control condition.
- Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
- Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Home Technology System | Experimental | Device: In-Home Technology System and QuestionnairesParticipants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter). |
| Waiting Control | Other | Device: Waiting Control In-Home Technology System and QuestionnairesParticipants will be assigned a date for receiving and installing the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) six months after they enter the study. During that six-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). At the end of the six-month period, participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional six-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caregivers are fluent/literate in English
- Caregivers currently reside with spouse/family member who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment
- Caregivers primarily use a smartphone (e.g., iPhone, Android)
- Caregiver has wireless internet in home
Key exclusion criteria (9 listed)
- Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition
- Caregivers providing care for individuals with longstanding Axis I psychiatric disorder
- Caregivers providing care for individuals with metabolic disorder or major organ dysfunction
- Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)
- Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes
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 |
|---|---|---|
| In-Home Technology System and QuestionnairesParticipants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment. | Device | In-Home Technology System |
| Waiting Control In-Home Technology System and QuestionnairesParticipants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment. | Device | Waiting Control |
Primary outcome
3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 3 months after baseline
Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 6 months after baseline
Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
3 Months Assessment for Zarit Burden Interview-Short Form
Time frame: 3 months after baseline
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
6 Months Assessment for Zarit Burden Interview-Short Form
Time frame: 6 months after baseline
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
3 Months Assessment for Beck Anxiety Inventory (BAI)
Time frame: 3 months after baseline
Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
6 Months Assessment for Beck Anxiety Inventory (BAI)
Time frame: 6 months after baseline
Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
3 Months Assessment for Satisfaction With Life Scale
Time frame: 3 months after baseline
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
6 Months Assessment for Satisfaction With Life Scale
Time frame: 6 months after baseline
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29216633Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.
- Background: PubMed 28655841Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.
- Background: PubMed 28395276Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.
- Background: PubMed 29289452Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.
- Derived from this study: PubMed 38537622Bullard BM, Brown CL, Scheffer JA, Toledo AB, Levenson RW. Emotion Regulation Strategies and Mental Health in Dementia Caregivers: The Moderating Role of Gender. Dement Geriatr Cogn Disord. 2024;53(3):128-134. doi: 10.1159/000538398. Epub 2024 Apr 22.
- Individual participant dataSharing planned: Yes. Because health and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.
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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.
Robert W Levenson, Ph.D. study director
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Home Technology System and Questionnaires in people with Dementia and Mild Cognitive Impairment, run by University of California, Berkeley 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 4 inclusion and 9 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 10 May 2022. 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?
Yes. Results are posted in the registry (first posted 10 May 2022). 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?
3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) (time frame: 3 months after baseline). The study lists 8 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 NCT04206670, which also lists 5 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 10 May 2022.