Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Idiopathic Pulmonary Fibrosis, Fibrosis, IPF, Caregivers, Pulmonary, Palliative, end of life, Idiopathic
Brief 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.
Detailed 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.
Interventions
OTHERSUPPORT
Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.
OTHERCurrently Available Printed Material
Subjects will receive their usual standard of care, including currently available printed patient material.
Sponsors
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress | 3 years | Perceived Stress Scale at baseline and completion of study in patients and caregivers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge | 3 years | Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers |
| Advance Care Planning | 3 years | Survey to measure completion of advance care plan at study completion with patients |
| Disease Preparedness | 3 years | Survey to measure preparation for disease course at completion of study for patients and caregivers. |
| Symptom Burden | 3 years | Promis-29 to measure symptom burden in patients at baseline and study completion. |
| Health Related Quality of Life in IPF | 3 years | ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion. |
| Quality of Dying and Death | 3 years | Quality of Dying and Death for caregivers if patient deceased during study |
Countries
United States
Outcome results
None listed