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Evaluation of Patient Education Simulations to Promote Health and Wellness

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Education Simulation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease focused on measuring Lifestyle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years or older;
  2. 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
  3. Receiving care within the NYU Langone Health Network (e.g., Faculty Group Practices and ambulatory care centers, NYU Winthrop Surgical Associates)

Exclusion Criteria:

  1. Are unable to give informed consent
  2. Refuse to participate
  3. 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.
  4. 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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Education Simulation

Arm Description

All participants will have access to the virtual education simulations.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
April 16, 2020
Last Updated
February 7, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04352179
Brief Title
Evaluation of Patient Education Simulations to Promote Health and Wellness
Official Title
Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
July 24, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Lifestyle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Education Simulation
Arm Type
Experimental
Arm Description
All participants will have access to the virtual education simulations.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Education Simulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling
Description
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.
Time Frame
Immediately post-simulation (Day 0)
Secondary Outcome Measure Information:
Title
Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
Description
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.
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Score of Short Portable Mental Status Questionnaire (SPMSQ)
Description
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.
Time Frame
Baseline (Day 0)
Title
Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
Description
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.
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Score of Patient Health Questionnaire-8 (PHQ-8)
Description
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.
Time Frame
Baseline (Day 0)
Title
Change in amount of days of physical activity
Description
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.
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
Description
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.
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Change in Score of Self Efficacy Exercising Questionnaire
Description
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.
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Change in Intrinsic Motivation for Eating Fruits and Vegetables
Description
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.
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Change in Intrinsic Motivation for Exercising
Description
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).
Time Frame
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Title
Self Efficacy in Seeking Mental Health Treatment (SESMHC)
Description
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.
Time Frame
Immediately post-simulation (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette Shoenthaler, EdD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Antoinette.Schoenthaler@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Evaluation of Patient Education Simulations to Promote Health and Wellness

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