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OpenTrials
Completed

NCT Number: NCT02929017

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Death Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SUPPORT

Other

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

Other

Subjects will receive their usual standard of care, including currently available printed patient material.

Other names: Usual Standard of Care

Primary outcomes

  1. Stress

    Time frame: 3 years

    Perceived Stress Scale at baseline and completion of study in patients and caregivers

Secondary outcomes

  1. Disease Preparedness

    Time frame: 3 years

    Survey to measure preparation for disease course at completion of study for patients and caregivers.

  2. Knowledge

    Time frame: 3 years

    Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers

  3. Advance Care Planning

    Time frame: 3 years

    Survey to measure completion of advance care plan at study completion with patients

  4. Quality of Dying and Death

    Time frame: 3 years

    Quality of Dying and Death for caregivers if patient deceased during study

  5. Symptom Burden

    Time frame: 3 years

    Promis-29 to measure symptom burden in patients at baseline and study completion.

  6. Health Related Quality of Life in IPF

    Time frame: 3 years

    ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2016
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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