- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352179
Evaluation of Patient Education Simulations to Promote Health and Wellness
Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Virtual Education Simulation
All participants will have access to the virtual education simulations.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Immediately post-simulation (Day 0)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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.
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Score of Short Portable Mental Status Questionnaire (SPMSQ)
Time Frame: Baseline (Day 0)
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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.
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Baseline (Day 0)
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Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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.
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Score of Patient Health Questionnaire-8 (PHQ-8)
Time Frame: Baseline (Day 0)
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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.
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Baseline (Day 0)
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Change in amount of days of physical activity
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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.
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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.
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Change in Score of Self Efficacy Exercising Questionnaire
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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.
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Change in Intrinsic Motivation for Eating Fruits and Vegetables
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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.
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Change in Intrinsic Motivation for Exercising
Time Frame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
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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).
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Baseline (Day 0), Day 30 +/- 7 days post-intervention
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Self Efficacy in Seeking Mental Health Treatment (SESMHC)
Time Frame: Immediately post-simulation (Day 0)
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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.
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Immediately post-simulation (Day 0)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antoinette Shoenthaler, EdD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-00460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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