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

NCT02929017 | Completed

• 2 other identifiers: PRO160705391K23NR016276-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; Fibrosis; IPF; Caregivers; Pulmonary; Palliative; end of life; Idiopathic

Outcome Measures

Primary Outcomes (1)

• Stress

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

  3 years

Secondary Outcomes (6)

• Disease Preparedness

  3 years

• Knowledge

  3 years

• Advance Care Planning

  3 years

• Quality of Dying and Death

  3 years

• Symptom Burden

  3 years

Study Arms (2)

Intervention

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.

Other: SUPPORT

Usual Care

OTHER

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

Interventions

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.

Intervention

Currently Available Printed Material OTHER

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

Also known as: Usual Standard of Care

Usual Care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Lindell KO, Klein SJ, Veatch MS, Gibson KF, Kass DJ, Nouraie M, Rosenzweig MQ. Nurse-Led Palliative Care Clinical Trial Improves Knowledge and Preparedness in Caregivers of Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Nov;18(11):1811-1821. doi: 10.1513/AnnalsATS.202012-1494OC.

  PMID: 34003726 DERIVED

• Lindell KO, Nouraie M, Klesen MJ, Klein S, Gibson KF, Kass DJ, Rosenzweig MQ. Randomised clinical trial of an early palliative care intervention (SUPPORT) for patients with idiopathic pulmonary fibrosis (IPF) and their caregivers: protocol and key design considerations. BMJ Open Respir Res. 2018 Feb 19;5(1):e000272. doi: 10.1136/bmjresp-2017-000272. eCollection 2018.

  PMID: 29531748 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Fibrosis; Death

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kathleen O Lindell, PhD, RN

  Dorothy P. and Richard P. Simmons Center for ILD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 10, 2016
• Study Start: March 23, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)