Overview

Condition idiopathic pulmonary fibrosis
Treatments support, currently available printed material
Sponsor University of Pittsburgh
Start date March 2017
End date April 2019
Trial size 80 participants
Trial identifier NCT02929017, PRO16070539

Summary

Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.

At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning. The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention.

Recruiting in the following locations…

United States Pennsylvania
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose supportive care
Masking participant, care provider
Arm
(Other)
Group will receive SUPPORT, an intervention that provides information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, and digitally (via use of a tablet) delivered by an interventionist.
support
Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.
(Other)
Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness.
currently available printed material Usual Standard of Care
Subjects will receive their usual standard of care, including currently available printed patient material.

Primary Outcomes

Measure
Stress
time frame: 3 years

Secondary Outcomes

Measure
Disease Preparedness
time frame: 3 years
Knowledge
time frame: 3 years
Advance Care Planning
time frame: 3 years
Quality of Dying and Death
time frame: 3 years
Symptom Burden
time frame: 3 years
Quality of Life
time frame: 3 years

Eligibility Criteria

All participants at least 45 years old.

Inclusion Criteria: - 45 years or older - Primary Diagnosis of with Idiopathic Pulmonary Fibrosis (IPF) - Has a caregiver, 18 years or older (spouse/partner/child/family member/friend), willing to participate. - Sees a Simmons Center Physician for usual IPF care. Exclusion Criteria: - less than 45 years - Not diagnosed with IPF - Has an unwilling caregiver, or a caregiver under 18. - Does not see a Simmons Center Physician for usual IPF care.

Additional Information

Official title Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
Principal investigator Kathleen O Lindell, PhD, RN
Description Idiopathic Pulmonary Fibrosis (IPF) is a disease of aging associated with intense medical and financial burden and expected to grow in incidence within the US population. Median survival from diagnosis is 3.8 years, although some patients succumb to a rapid death within 6 months. New therapies have recently become available. While these medications slow the rate of pulmonary deterioration, they have no impact on ultimate survival or quality of life. Although transplantation is an effective surgical therapy, less than 20% of patients ever receive a lung transplant. The remaining 80% have few treatment options and a likely rapidly progressive downhill course. Despite the fatal prognosis, we have found that patients and caregivers often fail to understand the poor prognosis as the disease relentlessly progresses. At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning. The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention. Patients with IPF and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by University of Pittsburgh.