Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Idiopathic pulmonary fibrosis (IPF) is a progressive and heterogeneous fibrotic lung disease. It is universally fatal, with an average time to death between two to five years.
Patients with IPF experience significantly diminished quality of life and increased symptom burden. Besides dyspnea, cough, fatigue, and deconditioning, patients with IPF experience significant depression and anxiety. The benefit of palliative care has been demonstrated in several other diseases, notably, in metastatic lung cancer. Patients with metastatic lung cancer who were seen by palliative care at the time of their diagnosis and throughout their disease course were found to have increased survival, improved quality of life, and received less aggressive care at the end of their life. This finding has prompted significant research in the role of palliative care in other diseases, including chronic lung disease. A non-blinded, randomized trial of a multi-disciplinary breathlessness service intervention in patients with advanced disease including cancer, chronic obstructive lung disease (COPD), interstitial lung disease (ILD), and congestive heart failure demonstrated improvement in breathlessness, anxiety, and even survival. Specific Aim 1: Determine if quality of life is improved with a palliative care intervention. Specific Aim 2: Determine if depression and anxiety symptoms are decreased with a palliative care intervention. Secondary aims include an examination of pulmonary function tests (PFT), number of hospitalizations, and overall mortality as an effect of a palliative care intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of Care | Placebo Comparator | Standard of care for idiopathic pulmonary fibrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of spirometry | Spirometry is a commonly-used pulmonary function test (PFT) measuring lung function. Greater spirometry output will be considered a measure of greater treatment efficacy. | 6 months |
| Change from baseline of diffusing capacity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31900187 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Behavioral | Control group will receive standard of care treatment for IPF. |
|
Diffusing capacity is a commonly-used pulmonary function test (PFT) measuring the transfer of gas from air in the lung to the red blood cells in lung blood vessels. Greater diffusing capacity will be considered a measure of greater treatment efficacy. |
| 6 months |
| Change from baseline of lung volume | Lung volume is a commonly-used pulmonary function test (PFT) measuring the volume of inhaled or exhaled air. Greater lung volume will be considered a measure of greater treatment efficacy. | 6 months |
| Change from baseline of 6-minute walk distance | 6-minute walk distance will be considered as a measure of invention efficacy, with an increase in 6-minute walk distance considered a measure of greater treatment efficacy. | 6 months |
| Total number of hospitalizations due to any cause | Total number of hospitalizations due to any cause will be considered as a measure of intervention efficacy, with decrease hospitalizations in the treatment group considered a measure of greater treatment efficacy. | 6 months |
| All-cause mortality | All-cause mortality will be considered as a measure of intervention efficacy, with decrease in mortality in the treatment group considered a measure of greater treatment efficacy. | 6 months |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |