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

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ClinicalTrials.gov Identifier: NCT02929017
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Kathleen O. Lindell, PhD, RN, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Other: SUPPORT Other: Currently Available Printed Material Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 31, 2019


Arm Intervention/treatment
Intervention
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.
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.

Usual Care
Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness.
Other: Currently Available Printed Material
Subjects will receive their usual standard of care, including currently available printed patient material.
Other Name: Usual Standard of Care




Primary Outcome Measures :
  1. Stress [ Time Frame: 3 years ]
    Perceived Stress Scale at baseline and completion of study in patients and caregivers


Secondary Outcome Measures :
  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. Quality of Life [ Time Frame: 3 years ]
    ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929017


Contacts
Contact: Melinda J Klesen, BA 412-802-6860 klesenmj@upmc.edu
Contact: Michelle J MacPherson, MAT, BS 412-647-4537 macphersonmj@upmc.edu

Locations
United States, Pennsylvania
Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melinda J Klesen, BA    412-802-6860    klesenmj@upmc.edu   
Contact: Michelle J MacPherson, MAT    412-647-4537    macphersonmj@upmc.edu   
Sub-Investigator: Margaret Q Rosenzweig, PhD,FNP-BC,AOCNP,FAAN         
Sub-Investigator: Heidi Donovan, PhD, RN         
Sub-Investigator: Jared Chiarchiaro, MD         
Sub-Investigator: Kevin Gibson, MD         
Sub-Investigator: Daniel Kass, MD         
Sub-Investigator: Luis Ortiz, MD         
Sub-Investigator: Kristen Veraldi, MD         
Sub-Investigator: Seyed M Nouraie, MD, PhD         
Sub-Investigator: Melinda Klesen, BA         
Sub-Investigator: Michelle MacPherson, BS, MAT         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Kathleen O Lindell, PhD, RN Dorothy P. and Richard P. Simmons Center for ILD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathleen O. Lindell, PhD, RN, Research Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02929017     History of Changes
Other Study ID Numbers: PRO16070539
1K23NR016276-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen O. Lindell, PhD, RN, University of Pittsburgh:
Idiopathic Pulmonary Fibrosis
Fibrosis
IPF
Caregivers
Pulmonary
Palliative
end of life
Idiopathic

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial