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

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Progressive Pulmonary Fibrosis; Interstitial Lung Disease

Treatments: Other: SUPPORT-T Educational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07269262

Pro00146761

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥18 years
• Confirmed diagnosis of PPF
• English or Spanish speaking

Caregiver Inclusion Criteria:

• 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.

Exclusion criteria

-

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

SUPPORT-T Intervention Arm

Experimental group

Description:

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

Treatment:

Other: SUPPORT-T Educational Intervention

Enhanced Usual Care Control Group

No Intervention group

Description:

* 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