SUPPORT-T in Patients With Progressive Pulmonary Fibrosis and Their Caregivers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

This pilot randomized controlled trial evaluates the feasibility, acceptability, and accessibility of SUPPORT-T, a digitally delivered palliative care intervention for patients with Progressive Pulmonary Fibrosis (PPF) and their caregivers. The intervention includes a 9-week digital application guided by a nurse interventionist and quarterly virtual support groups over one year. Participants will be recruited from rural South Carolina and urban New York City. The study compares SUPPORT-T to Enhanced Usual Care and aims to inform a future multi-site trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years

Confirmed diagnosis of PPF

English or Spanish speaking

adult, ≥ 18 years old

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • SUPPORT-T Educational Intervention

    Other intervention

    SUPPORT-T will be delivered biweekly at TeleHealth Visits 1-4 via a secure interface via MUSC telehealth platform. The nurse interventionist will receive results from the REDCap survey after each TH visit and contact the patient biweekly after each TH visit using the MUSC Telehealth and/or Health platform. The nurse interventionist will be available for any questions and communicate with the participants via bi-directional texts (SC will maintain a log of those texts)

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: SUPPORT-T Intervention ArmExperimental treatment 1 intervention
Group B: Enhanced Usual Care Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Disease Preparedness

Feasibility outcomes include number of participants recruited weekly, number of participants who declined, and number of participants who did not meet eligibility requirements, data collection procedures, and participant responses. Feasibility data will inform future studies on approaches for recruitment and retention, study procedures, and timing and participant capacity to complete surveys/interviews.

Time frame
10 months
2

Disease Preparedness Feasibility

Feasibility outcomes include number of participants recruited weekly, number of participants who declined, and number of participants who did not meet eligibility requirements, data collection procedures, and participant responses. Feasibility data will inform future studies on approaches for recruitment and retention, study procedures, and timing and participant capacity to complete surveys/interviews.

Time frame
10 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institutes of Health (NIH)

Collaborator