- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07269262
SUPPORT-T in Patients With Progressive Pulmonary Fibrosis and Their Caregivers
Feasibility and Acceptability of a Mobile Application "SUPPORT-T" to Increase Equitable Access to Palliative Care in Patients With Progressive Pulmonary Fibrosis (PPF) and Their Caregivers
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathleen Lindell, PhD, RN, ATSF, FAAN
- Phone Number: (843) 792-9763
- Email: lindellk@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Kathleen Lindell, PhD, RN, ATSF, FAAN
- Phone Number: (843) 792-9763
- Email: lindellk@musc.edu
-
Contact:
- Mary Chris Pittman, BA
- Phone Number: 8432594689
- Email: pittmama@musc.edu
-
Principal Investigator:
- Kathleen Lindell, PhD, RN, ATSF, FAAN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SUPPORT-T Intervention Arm
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 |
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)
|
|
No Intervention: Enhanced Usual Care Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Disease Preparedness
Time Frame: 10 months
|
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
Time Frame: 10 months
|
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
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00146761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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