Chronic DiseaseNCT04352179
Evaluation of Patient Education Simulations to Promote Health and Wellness
A study testing Virtual Education Simulation in people with Chronic Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This pilot study will use a pre-post design to explore the utility of using virtual simulations to provide participant education and counseling for adopting healthy lifestyle behaviors (i.e., physical activity, nutrition, smoking, alcohol use, and anxiety/distress screening) to 60 participants with chronic diseases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Virtual Education Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2019to 1 Oct 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Have a diagnosis of a chronic disease (e.g., osteoarthritis, coronary artery disease, chronic obstructive pulmonary disease, asthma, diabetes, hypertension, stroke, and congestive heart failure) as indicated by self-report or review of the electronic medical record; and
- Receiving care within the NYU Langone Health Network (e.g., Faculty Group Practices and ambulatory care centers, NYU Winthrop Surgical Associates)
Who cannot join
- Are unable to give informed consent
- Refuse to participate
- Any active terminal illness, mental incompetence, or uncontrolled psychiatric illness. These exclusions were based on the premise that the presence of any of these conditions would dominate the subject's perception of lifestyle management of their chronic disease.
- Unable to speak and read in English. Patients that are unable to speak and read in English will be excluded from the proposed project because the simulations are being developed in English only. Once we demonstrate the initial efficacy of this tool, future simulations will be developed in languages other than English. Despite the language restrictions, no exclusion will be made based on patient racial/ethnic origin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease
This pilot study will use a pre-post design to explore the utility of using virtual simulations to provide participant education and counseling for adopting healthy lifestyle behaviors (i.e., physical activity, nutrition, smoking, alcohol use, and anxiety/distress screening) to 60 participants with chronic diseases where lifestyle management is paramount to well-being and disease control (e.g., cardiovascular disease, stroke, diabetes, cancer, chronic obstructive pulmonary disease, osteoarthritis). Participants will have access to the simulations through a unique password-protected link over the course of one month. Participants will complete two study visits that are 30-60 minutes in duration each. There is also one optional telephone interview with a mental health professional. The telephone interview it estimated to be 10 minutes in duration and will be audiotapes, with participants' permission. The study surveys will be administrated at baseline, immediately following the simulation use and at one-month baseline measures. The measures will assess lifestyle behaviors related to healthy eating, physical activity, emotional health, smoking behaviors and alcohol use. Measures will also assess the psycho-social constructs of intrinsic motivation and self-efficacy. Finally, the usability of and satisfaction with the simulations will be explored through feedback surveys. The investigator will also seek permission to collect data from the patient's medical chart. Feedback will also be collected from four healthcare providers.
Read the detailed description
The overarching goal of the pilot study is to assess the acceptability and potential efficacy of the participant education simulation on changes in participants with chronic diseases' lifestyle behaviors as well as motivation and self-efficacy to change.
The primary objective is to examine the acceptability (satisfaction, usability) of using virtual simulations to deliver participant education and counseling for adopting healthy lifestyle behaviors among a sample of four healthcare providers and 60 participants with chronic disease. The secondary objectives include examining changes in lifestyle behaviors (e.g., healthy eating, physical activity) one-month following the use of the participant education simulations in a sample of 60 participants with chronic disease (e.g. cancer, cardiovascular disease, diabetes, stroke, arthritis) and to explore the potential mediators (e.g. motivation and self-efficacy) of the simulation effects on the changes in participants' lifestyle behaviors.
Participants will communicate with a virtual human, Linda, by selecting from a dynamic menu of dialogue options. Once the learner chooses a dialogue option, they see the virtual human respond by providing personalized feedback and give users an opportunity to revise their choice. In this study, the simulations will be a bundle of four topic-based conversations with Linda, which include fitness and nutrition, smoking cessation, alcohol use, distress and anxiety.
- Conditions
- Chronic Disease
- Being tested
- Virtual Education Simulation
- Keywords
- Lifestyle
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Education SimulationBehavioural
The simulations will be developed using Kognito's proprietary Conversation Platform.
In this pilot study, the simulations will be a bundle of four topic-based conversations with Linda, a virtual peer with a chronic disease. The four wellness topics are:
- Fitness \& Nutrition
- Smoking Cessation
- Alcohol Use
- Distress \& Anxiety
| Study group | Role | What they receive |
|---|---|---|
| Virtual Education Simulation | Experimental | All participants will have access to the virtual education simulations. Receives: Behavioral: Virtual Education Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling
A Usability Questionnaire will be used for participants to rate how much they agree or disagree with 14 questions as they relate to the participants' conversation with the virtual coach. Choices for each question range include: strongly disagree, somewhat disagree, somewhat agree, and strongly agree. No numerical scale is used.
Measured: Immediately post-simulation (Day 0)
Secondary outcomes (10)
Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
The AASE Scale consists of 40 situations that lead some people to drink. Participants mark answers which reflect how tempted they may be to drink in each situation at the present time. The answers choices range from 0 (not at all) to 4 (extremely). The range of score is 0-160. The higher the score, the higher the temptation to drink.
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Score of Short Portable Mental Status Questionnaire (SPMSQ)
10 questions will be asked to the participants. All responses must be given without reference to calendar, newspaper, birth certificate, or other aid to memory. The total number of errors based on the answers to the 10 questions will be recorded as the score. The lower the score, the better. 0-2 errors = Intact Intellectual Functioning, 3-4 errors = Mild Intellectual Impairment, 5-7 errors = Moderate Intellectual Impairment, 8-10 errors = Severe Intellectual Impairment.
Measured: Baseline (Day 0)
Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
The SASEQ consists of 6 situations that lead some people to smoke. Participants mark answers which reflect how confident they feel that they will not smoke in each situation. The answer choices range from 0 (certainly) to 4 (certainly not). The range of score is 0-24.
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Score of Patient Health Questionnaire-8 (PHQ-8)
PHQ-8 consists of 8 problem situations. The questionnaire asks the participants how often they have been bothered by each problem over the last 2 weeks. The total score ranges from 0-12, with categories of psychological distress being: none (0-2), mild (3-5), moderate (6-8), and severe (9-12). Therefore, the lower the score, the better.
Measured: Baseline (Day 0)
Change in amount of days of physical activity
Three types of physical activity will be reported on: vigorous, moderate, and walking. Participants will report how many days they did vigorous physical activities (like heavy lifting, digging, aerobics, or fast bicycling), how many days they did moderate (carrying light loads, bicycling at a regular pace, doubles tennis), and how many days they walked for at least 10 minutes during the last 7 days.
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
This questionnaire consists of 10 statements. The participant must rate how confident they are about each of the statements. The responses range from 0 (not at all sure) to 3 (very sure). The total score ranges from 0-30. The higher the score, the more confident the participant is about incorporating fruits and vegetables into their lifestyle.
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Score of Self Efficacy Exercising Questionnaire
This questionnaire consists of 11 statements. The participant must rate how confident they are about each of the statements. The responses range from 0 (not at all sure) to 3 (very sure). The total score ranges from 0-30. The higher the score, the more confident the participant is about incorporating exercise into their lifestyle.
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Intrinsic Motivation for Eating Fruits and Vegetables
In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale. Why they eat fruits and vegetables (from a list of 17 reasons). Each individual question is assessed separately, so no total range is given.
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Intrinsic Motivation for Exercising
In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale. Why they choose to exercise (from a list of 15 reasons).
Measured: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Self Efficacy in Seeking Mental Health Treatment (SESMHC)
This questionnaire consists of 9 statements. Participants are asked to rate how confident they are about each of the statements. Their responses range from 0 (no confidence) to 4 (complete confidence). The total score ranges from 0-36. The higher the score, the more confident the participant is about seeking mental health care.
Measured: Immediately post-simulation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start5 Dec 2019
- Primary completion24 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoinette Shoenthaler, EdD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352179
- Sponsor's protocol ID
- 19-00460
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease
- ClinicalTrials.gov ID
- NCT04352179
- Acronym / sponsor ID
- 19-00460
- Conditions
- Chronic Disease
- Keywords
- Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 20 Apr 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.
This pilot study will use a pre-post design to explore the utility of using virtual simulations to provide participant education and counseling for adopting healthy lifestyle behaviors (i.e., physical activity, nutrition, smoking, alcohol use, and anxiety/distress screening) to 60 participants with chronic diseases where lifestyle management is paramount to well-being and disease control (e.g., cardiovascular disease, stroke, diabetes, cancer, chronic obstructive pulmonary disease, osteoarthritis). Participants will have access to the simulations through a unique password-protected link over the course of one month. Participants will complete two study visits that are 30-60 minutes in duration each. There is also one optional telephone interview with a mental health professional. The telephone interview it estimated to be 10 minutes in duration and will be audiotapes, with participants' permission. The study surveys will be administrated at baseline, immediately following the simulation use and at one-month baseline measures. The measures will assess lifestyle behaviors related to healthy eating, physical activity, emotional health, smoking behaviors and alcohol use. Measures will also assess the psycho-social constructs of intrinsic motivation and self-efficacy. Finally, the usability of and satisfaction with the simulations will be explored through feedback surveys. The investigator will also seek permission to collect data from the patient's medical chart. Feedback will also be collected from four healthcare providers.
Detailed description
The overarching goal of the pilot study is to assess the acceptability and potential efficacy of the participant education simulation on changes in participants with chronic diseases' lifestyle behaviors as well as motivation and self-efficacy to change.
The primary objective is to examine the acceptability (satisfaction, usability) of using virtual simulations to deliver participant education and counseling for adopting healthy lifestyle behaviors among a sample of four healthcare providers and 60 participants with chronic disease. The secondary objectives include examining changes in lifestyle behaviors (e.g., healthy eating, physical activity) one-month following the use of the participant education simulations in a sample of 60 participants with chronic disease (e.g. cancer, cardiovascular disease, diabetes, stroke, arthritis) and to explore the potential mediators (e.g. motivation and self-efficacy) of the simulation effects on the changes in participants' lifestyle behaviors.
Participants will communicate with a virtual human, Linda, by selecting from a dynamic menu of dialogue options. Once the learner chooses a dialogue option, they see the virtual human respond by providing personalized feedback and give users an opportunity to revise their choice. In this study, the simulations will be a bundle of four topic-based conversations with Linda, which include fitness and nutrition, smoking cessation, alcohol use, distress and anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Education Simulation | Experimental | Behavioral: Virtual Education SimulationAll participants will have access to the virtual education simulations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older;
- Have a diagnosis of a chronic disease (e.g., osteoarthritis, coronary artery disease, chronic obstructive pulmonary disease, asthma, diabetes, hypertension, stroke, and congestive heart failure) as indicated by self-report or review of the electronic medical record; and
- Receiving care within the NYU Langone Health Network (e.g., Faculty Group Practices and ambulatory care centers, NYU Winthrop Surgical Associates)
Key exclusion criteria (4 listed)
- Are unable to give informed consent
- Refuse to participate
- Any active terminal illness, mental incompetence, or uncontrolled psychiatric illness. These exclusions were based on the premise that the presence of any of these conditions would dominate the subject's perception of lifestyle management of their chronic disease.
- Unable to speak and read in English. Patients that are unable to speak and read in English will be excluded from the proposed project because the simulations are being developed in English only. Once we demonstrate the initial efficacy of this tool, future simulations will be developed in languages other than English. Despite the language restrictions, no exclusion will be made based on patient racial/ethnic origin.
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 |
|---|---|---|
| Virtual Education SimulationThe simulations will be developed using Kognito's proprietary Conversation Platform. In this pilot study, the simulations will be a bundle of four topic-based conversations with Linda, a virtual peer with a chronic disease. The four wellness topics are: 1. Fitness \& Nutrition 2. Smoking Cessation 3. Alcohol Use 4. Distress \& Anxiety | Behavioural | Virtual Education Simulation |
Primary outcome
Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling
Time frame: Immediately post-simulation (Day 0)
A Usability Questionnaire will be used for participants to rate how much they agree or disagree with 14 questions as they relate to the participants' conversation with the virtual coach. Choices for each question range include: strongly disagree, somewhat disagree, somewhat agree, and strongly agree. No numerical scale is used.
10 secondary outcomes
Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Score of Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: Baseline (Day 0)
Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Score of Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline (Day 0)
Change in amount of days of physical activity
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Score of Self Efficacy Exercising Questionnaire
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Intrinsic Motivation for Eating Fruits and Vegetables
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Intrinsic Motivation for Exercising
Time frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Self Efficacy in Seeking Mental Health Treatment (SESMHC)
Time frame: Immediately post-simulation (Day 0)
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 9 Feb 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will 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.
Antoinette Shoenthaler, EdD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Education Simulation in people with Chronic Disease, run by NYU Langone Health 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 4 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 9 Feb 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?
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?
Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling (time frame: Immediately post-simulation (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.