Long COVID-19 Intervention Using Digital Health & Technology (LIGHT)

Project LIGHT - Long COVID-19 Intervention Using Digital Health & Technology

The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments

Study Overview

• Status: Not yet recruiting
• Conditions: Long COVID; Distress Tolerance
• Intervention / Treatment: Behavioral: iENDURE

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be over 18 years of age
• Must speak English proficiently
• Must own a text-enabled device
• Diagnosis (self-reported) of COVID-19
• Diagnosis (self-reported) of Long-COVID symptom(s)
• Must be able to provide written, informed consent

Exclusion Criteria:

• Not fluent in English
• Limited mental capacity or inability to provide informed written consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: distress tolerance skills training; technology delivered distress tolerance skills training

Behavioral: iENDURE; Two delivery modes: computer and text message. The intervention provides introductory strategies for managing physical and emotional distress associated with Long COVID through a computer-delivered session followed by 4-weeks of theoretically-informed text messages intended to promote distress tolerance (DT). Computer - the initial intervention will be delivered online via the Qualtrics survey tool following informed consent. The intervention provides strategies to better tolerate emotional and physical discomfort to persist with behavioral goals. Text Message - The text message intervention will be delivered using Marigold Health (a HIPAA compliant platform for secure text messaging). Participants will receive daily text messages that focus on emphasizing adaptive strategies for tolerating physical and emotional discomfort in order to work toward behavioral goals. The text messages will be personalized and offer skills training (reminders of previously learned DT skills).; Other Names: Marigold Health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Score (CSQ-8)	Measure satisfaction scores after 4 weeks of using the intervention for this group of participants with Long COVID as measured by the client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.	4 weeks
System Usability Score (SUS)	Measure usability after 4 weeks for this group of participants with Long COVID as measured by the 10 item system usability scale. In the SUS instrument, even and odd questions are scored differently. Odd questions are scored 0-4 based on the 1-5 selection, where a selection of 1 equals 0 points, a selection of 2 equals 1 point, and so on. Even questions are scored 4-0 on the 1-5 selection where a selection of 1 equals 4 points, a selection of 2 equals 3 points, and so on. Scores for all ten questions are added up for a total score between 0-40 points. This total is multiplied by 2.5 to generate a SUS score between 0-100 points. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.	4 weeks

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Brown University
• Investigators: Principal Investigator: Kirsten Langdon, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022003396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No