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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Feasibility of Disease Preparedness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: SUPPORT-T Educational Intervention (Other)
Enhanced Usual Care Control Group
- 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
结局指标
主要结局
Feasibility of Disease Preparedness
时间窗: 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.
Disease Preparedness Feasibility
时间窗: 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.
次要结局
未报告次要终点
研究者
Kathleen Lindell
Associate Professor-Faculty
Medical University of South Carolina