Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929017
• Other study ID #: PRO16070539
• Secondary ID: 1K23NR016276-01A
• Status: Completed
• Phase: N/A
• Start date: March 23, 2017
• Est. completion date: June 24, 2020

Study information

• Verified date: August 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• 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.
• Currently Available Printed Material
Subjects will receive their usual standard of care, including currently available printed patient material.

Locations

Country	Name	City	State
United States	Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress	Perceived Stress Scale at baseline and completion of study in patients and caregivers	3 years
Secondary	Disease Preparedness	Survey to measure preparation for disease course at completion of study for patients and caregivers.	3 years
Secondary	Knowledge	Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers	3 years
Secondary	Advance Care Planning	Survey to measure completion of advance care plan at study completion with patients	3 years
Secondary	Quality of Dying and Death	Quality of Dying and Death for caregivers if patient deceased during study	3 years
Secondary	Symptom Burden	Promis-29 to measure symptom burden in patients at baseline and study completion.	3 years
Secondary	Health Related Quality of Life in IPF	ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.	3 years