Patient Centered Outcomes ResearchNCT02537886
Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
An observational study of Patient Centered Outcomes Research, run by Yale University at 1 site in United States.
Trial summary
The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Patient Centered Outcomes Research
- What is being tested?
- Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 30 Apr 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study includes patients from the Yale Center for Asthma and Airway Disease (YCAAD) clinic. Participants for the VIC study will be recruited from the large and diverse asthma population that the YCAAD GenEx 2.0 trial accesses for enrollment.
Who may be able to join
- Clinician diagnosis of asthma based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- Historical evidence of variable airflow obstruction.
- Subjects are required to speak English.
Who cannot join
- >10 pack-year smoking history.
- Active smoking within the past year.
- Other chronic lung disease or asthma variant.
- Patients will be excluded if they cannot safely undergo the studies required for participation.
- Patient or clinician refusal to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine: Dept of Emergency Medicine
New Haven, Connecticut, 06511
About this study
The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. The development of VIC is to create a reusable infrastructure for integrating the informed consent process into clinical care and the clinical workflow in a way that enhances patient comprehension while improving the efficiency of obtaining patient consent.
Read the detailed description
The informed consent process protects patients and ensures ethical conduct of research. For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives to medical procedures or clinical research as well as a patient's rights and responsibilities. Patient safety and quality of care are at risk if the informed consent process is not delivered in a way that assures patient comprehension.
Adoption of methods that allow researchers to conduct brief and virtual interviews with participants to complete the informed consent process using tablet computers (e.g. iPads) with a comprehensive multimedia library (e.g. video clips, animations, presentations, etc.) to explains the risks, benefits, and alternatives of the clinical care will enhance patient comprehension.
The goal of this project is to help make the conduct of patient centered outcomes research (PCOR) more efficient and more widely implemented by engaging key stakeholders, including patients, through the development and evaluation of a new mobile health (mHealth) informed consent tool to disseminate PCOR findings in informed consent research.
This study will be conducted over a 15 month period and will consist of 6 parts: (1) Front-End Focus Groups, (2) User Requirements Analysis, (3) Screen Prototypes Usability Focus Groups, (4) Design and Implementation, (5) Before Launch Usability Evaluation, (6) After Launch Usability Evaluation. Given the steps in the process and the changing (i.e. different) subjects/participants in each component of the development process, this study registration record primarily summarizes the final step in the development of VIC.
- Conditions
- Patient Centered Outcomes Research
- Being tested
- Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)
- Keywords
- PCOR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)Device
Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation Group | Researchers will conduct a focus group to evaluate VIC after it has been developed and used by patients. Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC. We will use this information to enhance the generalizability of the VIC approach. Receives: Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VIC Focus Group Feedback
Asthma Patients will use the VIC to complete the informed consent on an iPad. Following 3-5 weeks of use, 8-10 users will be selected to take part in a focus group to evaluate the usability of VIC. The intent of this post-launch focus group, will be to gather opinions, beliefs, and attitudes about VIC. The focus group data will be used to arrive at themes that are common among the focus group participants. This feedback will be used to assess the completed VIC tool and inform further development of such tools.
Measured: 3-5 weeks following the launch of VIC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJun 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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 Patient Centered Outcomes ResearchStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuad Abujarad, MD, Principal investigator, Yale School of Medicine: Dept of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537886
- Sponsor's protocol ID
- 1501015262
- Other IDs
- R21HSO22319-01A1
- Status last verified
- May 2019
- First submitted
- 20 Aug 2015
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Abujarad F, Peduzzi P, Mun S, Carlson K, Edwards C, Dziura J, Brandt C, Alfano S, Chupp G. Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial. JMIR Form Res. 2021 Oct 19;5(10):e20458. doi: 10.2196/20458.
PubMed 34665142
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
- ClinicalTrials.gov ID
- NCT02537886
- Acronym / sponsor ID
- 1501015262
- Conditions
- Patient Centered Outcomes Research
- Keywords
- PCOR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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 Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. The development of VIC is to create a reusable infrastructure for integrating the informed consent process into clinical care and the clinical workflow in a way that enhances patient comprehension while improving the efficiency of obtaining patient consent.
Detailed description
The informed consent process protects patients and ensures ethical conduct of research. For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives to medical procedures or clinical research as well as a patient's rights and responsibilities. Patient safety and quality of care are at risk if the informed consent process is not delivered in a way that assures patient comprehension.
Adoption of methods that allow researchers to conduct brief and virtual interviews with participants to complete the informed consent process using tablet computers (e.g. iPads) with a comprehensive multimedia library (e.g. video clips, animations, presentations, etc.) to explains the risks, benefits, and alternatives of the clinical care will enhance patient comprehension.
The goal of this project is to help make the conduct of patient centered outcomes research (PCOR) more efficient and more widely implemented by engaging key stakeholders, including patients, through the development and evaluation of a new mobile health (mHealth) informed consent tool to disseminate PCOR findings in informed consent research.
This study will be conducted over a 15 month period and will consist of 6 parts: (1) Front-End Focus Groups, (2) User Requirements Analysis, (3) Screen Prototypes Usability Focus Groups, (4) Design and Implementation, (5) Before Launch Usability Evaluation, (6) After Launch Usability Evaluation. Given the steps in the process and the changing (i.e. different) subjects/participants in each component of the development process, this study registration record primarily summarizes the final step in the development of VIC.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation Group | – | Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)Researchers will conduct a focus group to evaluate VIC after it has been developed and used by patients. Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC. We will use this information to enhance the generalizability of the VIC approach. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study includes patients from the Yale Center for Asthma and Airway Disease (YCAAD) clinic. Participants for the VIC study will be recruited from the large and diverse asthma population that the YCAAD GenEx 2.0 trial accesses for enrollment.
Key inclusion criteria (3 listed)
- Clinician diagnosis of asthma based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- Historical evidence of variable airflow obstruction.
- Subjects are required to speak English.
Key exclusion criteria (5 listed)
- >10 pack-year smoking history.
- Active smoking within the past year.
- Other chronic lung disease or asthma variant.
- Patients will be excluded if they cannot safely undergo the studies required for participation.
- Patient or clinician refusal to participate.
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 |
|---|---|---|
| Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC. | Device | Evaluation Group |
Primary outcome
VIC Focus Group Feedback
Time frame: 3-5 weeks following the launch of VIC
Asthma Patients will use the VIC to complete the informed consent on an iPad. Following 3-5 weeks of use, 8-10 users will be selected to take part in a focus group to evaluate the usability of VIC. The intent of this post-launch focus group, will be to gather opinions, beliefs, and attitudes about VIC. The focus group data will be used to arrive at themes that are common among the focus group participants. This feedback will be used to assess the completed VIC tool and inform further development of such tools.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Derived from this study: PubMed 34665142Abujarad F, Peduzzi P, Mun S, Carlson K, Edwards C, Dziura J, Brandt C, Alfano S, Chupp G. Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial. JMIR Form Res. 2021 Oct 19;5(10):e20458. doi: 10.2196/20458.
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.
Fuad Abujarad, MD principal investigator
Yale School of Medicine: Dept of Emergency Medicine
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 Patient Centered Outcomes Research, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VIC Focus Group Feedback (time frame: 3-5 weeks following the launch of VIC). 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 NCT02537886, 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 3 May 2019; AzTrials last refreshed its copy on 27 Oct 2026.