Contemporary clinical trials communications · 2026
Pilot randomized controlled trial of a peer coach-led behavioral and educational intervention to enhance quality of life in patients living with hypersensitivity pneumonitis: Protocol for the RISE-HP study.
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Zhang C M, Chau K, Banerjee S, Swigris J J, Krishnan J K, Kaner R J, Martinez F J, Tobin J N, Safford M M, Aronson K I
Аннотация
BACKGROUND: Hypersensitivity Pneumonitis (HP) is an interstitial lung disease caused by an inhalational environmental exposure. Patients living with HP experience significant stress, uncertainty, and hypervigilance about the management of their disease and prognosis. These factors lead to reduced health-related quality of life (HRQOL), an important outcome that no interventions currently target.
OBJECTIVE: The goal of this behavioral and educational intervention, RISE-HP, is to improve HRQOL in people who have HP. The objective of this pilot study is to assess feasibility, acceptability, and preliminary effectiveness of the RISE-HP intervention.
METHODS: This pilot randomized controlled trial will be conducted in patients over the age of 18 with a diagnosis of HP. Forty participants will be randomly assigned to receive either the RISE-HP intervention (meetings with a peer coach focused on living well with their HP using cognitive behavioral techniques and motivational interviewing) or an attention control (general health education sessions with a research assistant) for 10 weeks. Participants will complete four additional study visits (enrollment, 5 weeks, 10 weeks, and 14 weeks after intervention start) for patient reported outcome measure completion. Primary implementation outcomes will be feasibility and acceptability. Secondary patient-centered effectiveness clinical outcomes will be improvement in HRQOL as measured by the Kings Brief Interstitial Lung Disease (KBILD) questionnaire. Additional secondary patient-reported clinical outcomes include fatigue, anxiety, depression, and self-efficacy.
CONCLUSION: Overall, this study addresses an important gap in HP care by targeting HRQOL and offers a novel non-pharmacologic patient-centered approach to therapy in patients with HP.
OBJECTIVE: The goal of this behavioral and educational intervention, RISE-HP, is to improve HRQOL in people who have HP. The objective of this pilot study is to assess feasibility, acceptability, and preliminary effectiveness of the RISE-HP intervention.
METHODS: This pilot randomized controlled trial will be conducted in patients over the age of 18 with a diagnosis of HP. Forty participants will be randomly assigned to receive either the RISE-HP intervention (meetings with a peer coach focused on living well with their HP using cognitive behavioral techniques and motivational interviewing) or an attention control (general health education sessions with a research assistant) for 10 weeks. Participants will complete four additional study visits (enrollment, 5 weeks, 10 weeks, and 14 weeks after intervention start) for patient reported outcome measure completion. Primary implementation outcomes will be feasibility and acceptability. Secondary patient-centered effectiveness clinical outcomes will be improvement in HRQOL as measured by the Kings Brief Interstitial Lung Disease (KBILD) questionnaire. Additional secondary patient-reported clinical outcomes include fatigue, anxiety, depression, and self-efficacy.
CONCLUSION: Overall, this study addresses an important gap in HP care by targeting HRQOL and offers a novel non-pharmacologic patient-centered approach to therapy in patients with HP.