Covid19NCT04568135
A Survey Study to Assess the Impact of the COVID-19 Pandemic on Participants With Pre-Existing Mental Health Diagnosis
An observational study of Covid19, run by Siyan Clinical Corporation.
Trial summary
The primary objective of this survey study is to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- survey
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 31 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a survey study designed to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. This survey is an exploratory investigation of patient experience to guide Siyan in program improvement and development of next steps to serve patients.
Who may be able to join
- Voluntarily agrees to participate in the study under their own free will and is willing/able to agree to an informed e-consent form indicating that he/she understands the purpose of the study, the procedures that are required for the study, and that he/she is willing to participate in the study.
- Female or male and between the ages of 18 and 80, inclusive at the time of consent.
- Is a currently receiving or has previously received psychiatric services from Siyan Clinical Corporation and/or Siyan Clinical Research practices.
- Is capable of understanding and complying with study requirements.
- Has agreed to the e-ICF. No study-related procedures will be performed before the participant has agreed to the consent letter.
Who cannot join
- A known diagnosis of dementia will not be included in the sample.
- Under the age of 18 or over the age of 80.
Trial locations and contacts
No sites are listed yet.
About this study
The primary objective of this survey study is to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. This survey study will utilize the Epidemic-Pandemic Impacts Inventory (EPII). This is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.
Read the detailed description
This study is a survey study designed to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. This survey is an exploratory investigation of patient experience to guide Siyan in program improvement and development of next steps to serve patients. A one-time survey will be sent out electronically via email to approximately 3,500 adult patients in the Siyan Clinical Corporation and Siyan Clinical Research practices. The survey will consist of the Epidemic-Pandemic Impacts Inventory (EPII). This is a new tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.
Siyan staff will derive a list of patients from the Siyan EHR who meet eligibility criteria. The list will include Patient ID, age, gender, ethnicity, occupation, employment status, primary diagnosis, and last known email address. Each patient in the sample will receive an email inviting them to participate in the survey, explaining the purpose of the survey, how Siyan will use the survey results, and how the survey will be administered. All patients in the sample who have not responded will also receive a reminder email approximately one week later. Each e-mail will include information to contact the Investigator with any questions.
Patients that reply to the initial invitation will receive the electronic Informed Consent Form (eICF) to sign and return to the Project Coordinator via Adobe Sign. The Project Coordinator will track the name and email address of all patients who consent to participate, and will send each a link to the online survey in SurveyGizmo. https://www.surveygizmo.com/s3/5751791/Siyan-COVIDImpactSurvey) The online survey will repeat the text of the electronic Informed Consent Form (eICF), allowing participants to again confirm agreement and continue the survey or disagree and exit out. Participants who agree to the consent will be asked to confirm their email address, and respond to the 92 questions in the EPII about how the coronavirus disease pandemic has changed their and/or their family's lives. Respondents will also be asked basic demographic questions: age, gender identity, ethnicity, education level, employment status, industry, children under 18 in the home, marital status, and experience with basic psychiatric disorders.
The evaluation consultant will tabulate responses and provide basic frequencies and analyses to the Investigator, along with a de-identified dataset for further advanced analysis. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. Analysis of data collected will be published in academic journals to serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19.
- Conditions
- Covid19
- Being tested
- survey
- Keywords
- survey, covid19, Pre-Existing Mental Health Diagnosis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
survey
| Study group | Role | What they receive |
|---|---|---|
| survey | Not described Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey: Epidemic-Pandemic Impacts Inventory (EPII)
The Epidemic-Pandemic Impacts Inventory (EPII) is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains. Candidate items were constructed by a team of clinical and developmental psychologists with expertise in assessment of stress, trauma, resilience, and coping. Feedback from professionals across multiple disciplines (e.g., social work, pediatrics, medicine, anthropology) was incorporated in selecting and refining final items for of the measure, which was accomplished via expert consensus.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start31 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siyan Clinical Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568135
- Sponsor's protocol ID
- SCR-SUR-001
- Status last verified
- Oct 2020
- First submitted
- 18 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah A, Darling M, Arstein-Kerslake O, Morgan T, Vance Tovrea A, Young J, Laines H. Measuring the Impact of COVID-19 on Siyan Mental Health Patients Using the Epidemic-Pandemic Impacts Inventory: Survey Study. JMIR Form Res. 2021 Jul 29;5(7):e29952. doi: 10.2196/29952.
PubMed 34323851
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey Study to Assess the Impact of the COVID-19 Pandemic on Participants With Pre-Existing Mental Health Diagnosis
- ClinicalTrials.gov ID
- NCT04568135
- Acronym / sponsor ID
- SCR-SUR-001
- Conditions
- Covid19
- Keywords
- survey, covid19, Pre-Existing Mental Health Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Siyan Clinical CorporationUniversity, hospital or other
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 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 primary objective of this survey study is to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. This survey study will utilize the Epidemic-Pandemic Impacts Inventory (EPII). This is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.
Detailed description
This study is a survey study designed to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. This survey is an exploratory investigation of patient experience to guide Siyan in program improvement and development of next steps to serve patients. A one-time survey will be sent out electronically via email to approximately 3,500 adult patients in the Siyan Clinical Corporation and Siyan Clinical Research practices. The survey will consist of the Epidemic-Pandemic Impacts Inventory (EPII). This is a new tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.
Siyan staff will derive a list of patients from the Siyan EHR who meet eligibility criteria. The list will include Patient ID, age, gender, ethnicity, occupation, employment status, primary diagnosis, and last known email address. Each patient in the sample will receive an email inviting them to participate in the survey, explaining the purpose of the survey, how Siyan will use the survey results, and how the survey will be administered. All patients in the sample who have not responded will also receive a reminder email approximately one week later. Each e-mail will include information to contact the Investigator with any questions.
Patients that reply to the initial invitation will receive the electronic Informed Consent Form (eICF) to sign and return to the Project Coordinator via Adobe Sign. The Project Coordinator will track the name and email address of all patients who consent to participate, and will send each a link to the online survey in SurveyGizmo. https://www.surveygizmo.com/s3/5751791/Siyan-COVIDImpactSurvey) The online survey will repeat the text of the electronic Informed Consent Form (eICF), allowing participants to again confirm agreement and continue the survey or disagree and exit out. Participants who agree to the consent will be asked to confirm their email address, and respond to the 92 questions in the EPII about how the coronavirus disease pandemic has changed their and/or their family's lives. Respondents will also be asked basic demographic questions: age, gender identity, ethnicity, education level, employment status, industry, children under 18 in the home, marital status, and experience with basic psychiatric disorders.
The evaluation consultant will tabulate responses and provide basic frequencies and analyses to the Investigator, along with a de-identified dataset for further advanced analysis. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. Analysis of data collected will be published in academic journals to serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| survey | – | Other: survey |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a survey study designed to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. This survey is an exploratory investigation of patient experience to guide Siyan in program improvement and development of next steps to serve patients.
Key inclusion criteria (5 listed)
- Voluntarily agrees to participate in the study under their own free will and is willing/able to agree to an informed e-consent form indicating that he/she understands the purpose of the study, the procedures that are required for the study, and that he/she is willing to participate in the study.
- Female or male and between the ages of 18 and 80, inclusive at the time of consent.
- Is a currently receiving or has previously received psychiatric services from Siyan Clinical Corporation and/or Siyan Clinical Research practices.
- Is capable of understanding and complying with study requirements.
- Has agreed to the e-ICF. No study-related procedures will be performed before the participant has agreed to the consent letter.
Key exclusion criteria (2 listed)
- A known diagnosis of dementia will not be included in the sample.
- Under the age of 18 or over the age of 80.
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 |
|---|---|---|
| surveysurvey | Other | survey |
Primary outcome
Survey: Epidemic-Pandemic Impacts Inventory (EPII)
Time frame: one year
The Epidemic-Pandemic Impacts Inventory (EPII) is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains. Candidate items were constructed by a team of clinical and developmental psychologists with expertise in assessment of stress, trauma, resilience, and coping. Feedback from professionals across multiple disciplines (e.g., social work, pediatrics, medicine, anthropology) was incorporated in selecting and refining final items for of the measure, which was accomplished via expert consensus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 34323851Shah A, Darling M, Arstein-Kerslake O, Morgan T, Vance Tovrea A, Young J, Laines H. Measuring the Impact of COVID-19 on Siyan Mental Health Patients Using the Epidemic-Pandemic Impacts Inventory: Survey Study. JMIR Form Res. 2021 Jul 29;5(7):e29952. doi: 10.2196/29952.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Siyan Clinical Corporation.
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 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Morgan (707-206-7268, tmorgan@siyanclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey: Epidemic-Pandemic Impacts Inventory (EPII) (time frame: one year). 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 NCT04568135, 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 14 Oct 2020.