Long COVID-19 Intervention Using Digital Health & Technology

NCT05616806 | Unknown

• 1 other identifier: 2022003396
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Long COVID; Distress Tolerance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

distress tolerance skills training

EXPERIMENTAL

technology delivered distress tolerance skills training

Behavioral: iENDURE

Interventions

iENDURE BEHAVIORAL

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).

Also known as: Marigold Health

distress tolerance skills training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Brown University: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsten Langdon, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 4, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)