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

NCT07269262 | Recruiting DMC

• 1 other identifier: Pro00146761
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Progressive Pulmonary Fibrosis; Interstitial Lung Disease

Keywords

Education; Interstitial Lung Disease (ILD)

Outcome Measures

Primary Outcomes (2)

• 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.

  10 months

• 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.

  10 months

Study Arms (2)

SUPPORT-T Intervention Arm

EXPERIMENTAL

Participants in the intervention arm will have a telehealth preparatory visit scheduled 1 week later (Week 2) with the Study Coordinator and will be provided with the study number to call with questions. 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). • All participants will complete questionnaires at Week 1, Week 9, Month 6, and Month 12

Other: SUPPORT-T Educational Intervention

Enhanced Usual Care Control Group

NO INTERVENTION

* Participants in the enhanced usual care arm will receive printed education materials from the Pulmonary Fibrosis Foundation (PFF) and the nurse interventionist's contact information. * All participants will complete questionnaires at Week 1, Week 9, Month 6, and Month 12

Interventions

SUPPORT-T Educational Intervention OTHER

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)

SUPPORT-T Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years
• Confirmed diagnosis of PPF
• English or Spanish speaking
• adult, ≥ 18 years old
• Designated and identified by patient as providing most of the emotional, financial, and/or physical support (i.e., the individual most involved in care, does not have to live with patient)
• Able to speak and understand English.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kathleen Lindell, PhD, RN, ATSF, FAAN

CONTACT

(843) 792-9763; lindellk@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)