Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis

NCT03981406 | Completed

• 1 other identifier: STUDY00000753
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of adding a palliative care intervention for patients with idiopathic pulmonary fibrosis (IPF) to current standard of care. Palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. This consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings. While the specific assistance and support provided by the Palliative Care Service depends on individual patient and family needs and preferences, it may include:

1. 1.Pain and symptom management
2. 2.Psychosocial and spiritual support
3. 3.Assistance with treatment choices
4. 4.Help in planning for care in the community

Conditions

Idiopathic Pulmonary Fibrosis; Depression; Anxiety; Depressive Disorder; Anxiety Disorders; Anxiety Depression

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (3)

• Change from baseline respiratory quality of life as measured by SGRQ

  The Saint George's Respiratory Questionnaire (SGRQ) is 50-item survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.

  6 months

• Change from baseline anxiety and depression symptoms as measured by HADS

  The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.

  6 months

• Change in prevalence of baseline depression as measured by PHQ-9

  The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.

  6 months

Secondary Outcomes (6)

• Change from baseline of spirometry

  6 months

• Change from baseline of diffusing capacity

  6 months

• Change from baseline of lung volume

  6 months

• Change from baseline of 6-minute walk distance

  6 months

• Total number of hospitalizations due to any cause

  6 months

Study Arms (2)

Palliative Care

EXPERIMENTAL

Palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. This consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings.

Behavioral: Palliative Care

Standard of Care

PLACEBO COMPARATOR

Standard of care for idiopathic pulmonary fibrosis

Behavioral: Standard of Care

Interventions

Palliative Care BEHAVIORAL

The intervention is one visit to the Fairview Clinics and Surgery Center palliative care clinic, with follow up visits as determined by the palliative care team and the patient.

Palliative Care

Standard of Care BEHAVIORAL

Control group will receive standard of care treatment for IPF.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• IPF as diagnosed by chest CT or lung biopsy, and documented by a pulmonologist in the patient's medical record
• Capacity to provide informed consent

You may not qualify if:

• Documented malignancy that would impact mortality within the study enrollment period
• Inability to pay for palliative care visit, insurance or personally.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Janssen K, Rosielle D, Wang Q, Kim HJ. The impact of palliative care on quality of life, anxiety, and depression in idiopathic pulmonary fibrosis: a randomized controlled pilot study. Respir Res. 2020 Jan 3;21(1):2. doi: 10.1186/s12931-019-1266-9.

  PMID: 31900187 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Depression; Anxiety Disorders; Depressive Disorder

Interventions

Palliative Care; Standard of Care

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: September 15, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)