Clinical trial NCT04352179: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Lifestyle
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling
timeFrame: Immediately post-simulation (Day 0)
Secondary outcomes:
measure: Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Score of Short Portable Mental Status Questionnaire (SPMSQ)
timeFrame: Baseline (Day 0)
measure: Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Score of Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline (Day 0)
measure: Change in amount of days of physical activity
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Change in Score of Self Efficacy Exercising Questionnaire
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Change in Intrinsic Motivation for Eating Fruits and Vegetables
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Change in Intrinsic Motivation for Exercising
timeFrame: Baseline (Day 0), Day 30 +/- 7 days post-intervention
measure: Self Efficacy in Seeking Mental Health Treatment (SESMHC)
timeFrame: Immediately post-simulation (Day 0)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Antoinette Shoenthaler, EdD
role: PRINCIPAL_INVESTIGATOR
References: