Evaluation of Patient Education Simulations to Promote Health and Wellness

NCT04352179 | Completed

• 1 other identifier: 19-00460
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately post-simulation (Day 0)

Secondary Outcomes (10)

• Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale

  Baseline (Day 0), Day 30 +/- 7 days post-intervention

• Score of Short Portable Mental Status Questionnaire (SPMSQ)

  Baseline (Day 0)

• Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)

  Baseline (Day 0), Day 30 +/- 7 days post-intervention

• Score of Patient Health Questionnaire-8 (PHQ-8)

  Baseline (Day 0)

• Change in amount of days of physical activity

  Baseline (Day 0), Day 30 +/- 7 days post-intervention

Study Arms (1)

Virtual Education Simulation

EXPERIMENTAL

All participants will have access to the virtual education simulations.

Behavioral: Virtual Education Simulation

Interventions

Virtual Education Simulation BEHAVIORAL

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: 1. Fitness \& Nutrition 2. Smoking Cessation 3. Alcohol Use 4. Distress \& Anxiety

Virtual Education Simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Are unable to give informed consent
• Refuse to participate

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoinette Shoenthaler, EdD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: December 5, 2019
• Primary Completion: July 24, 2021
• Study Completion: October 1, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)