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Clinical Trials/NCT05616806
NCT05616806Not yet recruitingNot Applicable

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

Rhode Island Hospital2 sites in 1 country10 target enrollmentStarted: July 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10
Locations
2
Primary Endpoint
System Usability Score (SUS)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

System Usability Score (SUS)

Time Frame: 4 weeks

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.

Client Satisfaction Score (CSQ-8)

Time Frame: 4 weeks

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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