Idiopathic Pulmonary FibrosisNCT03981406
Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis
A study testing Palliative Care in people with Idiopathic Pulmonary Fibrosis and Depression, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Depression, Anxiety
- What is being tested?
- Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Documented malignancy that would impact mortality within the study enrollment period
- Inability to pay for palliative care visit, insurance or personally.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
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:
- Pain and symptom management
- Psychosocial and spiritual support
- Assistance with treatment choices
- Help in planning for care in the community
Read the detailed description
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.
- Conditions
- Idiopathic Pulmonary Fibrosis, Depression, Anxiety, Depressive Disorder, Anxiety Disorders, Anxiety Depression
- Being tested
- Palliative Care, Standard of Care
- Keywords
- Palliative Care
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Depression, Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareBehavioural
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.
Standard of CareBehavioural
Control group will receive standard of care treatment for IPF.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Palliative Care |
| Standard of Care | Placebo comparator | Standard of care for idiopathic pulmonary fibrosis Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
Change from baseline of diffusing capacity
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start15 Sep 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981406
- Sponsor's protocol ID
- STUDY00000753
- Status last verified
- Jan 2020
- First submitted
- 6 Jun 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31900187
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03981406
- Acronym / sponsor ID
- STUDY00000753
- Conditions
- Idiopathic Pulmonary Fibrosis, Depression, Anxiety, Depressive Disorder, Anxiety Disorders, Anxiety Depression
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pain and symptom management
- Psychosocial and spiritual support
- Assistance with treatment choices
- Help in planning for care in the community
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative Care | Experimental | Behavioral: Palliative CarePalliative 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 | Behavioral: Standard of CareStandard of care for idiopathic pulmonary fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Documented malignancy that would impact mortality within the study enrollment period
- Inability to pay for palliative care visit, insurance or personally.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative CareThe 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. | Behavioural | Palliative Care |
| Standard of CareControl group will receive standard of care treatment for IPF. | Behavioural | Standard of Care |
Primary outcome
Change from baseline respiratory quality of life as measured by SGRQ
Time frame: 6 months
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.
Change from baseline anxiety and depression symptoms as measured by HADS
Time frame: 6 months
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.
Change in prevalence of baseline depression as measured by PHQ-9
Time frame: 6 months
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 secondary outcomes
Change from baseline of spirometry
Time frame: 6 months
Change from baseline of diffusing capacity
Time frame: 6 months
Change from baseline of lung volume
Time frame: 6 months
Change from baseline of 6-minute walk distance
Time frame: 6 months
Total number of hospitalizations due to any cause
Time frame: 6 months
All-cause mortality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 31900187Janssen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care in people with Idiopathic Pulmonary Fibrosis and Depression, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline respiratory quality of life as measured by SGRQ (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.