Idiopathic Pulmonary FibrosisNCT02929017
Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
A study testing SUPPORT and Currently Available Printed Material in people with Idiopathic Pulmonary Fibrosis, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- SUPPORT and Currently Available Printed Material
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to 24 Jun 2020
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- SUPPORT, Currently Available Printed Material
- Keywords
- Idiopathic Pulmonary Fibrosis, Fibrosis, IPF, Caregivers, Pulmonary, Palliative, end of life, Idiopathic
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Fibrosis, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPPORTOther
Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.
Currently Available Printed MaterialOther
Also called Usual Standard of Care
Subjects will receive their usual standard of care, including currently available printed patient material.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Currently Available Printed Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Perceived Stress Scale at baseline and completion of study in patients and caregivers
Measured: 3 years
Secondary outcomes (6)
Disease Preparedness
Survey to measure preparation for disease course at completion of study for patients and caregivers.
Measured: 3 years
Knowledge
Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers
Measured: 3 years
Advance Care Planning
Survey to measure completion of advance care plan at study completion with patients
Measured: 3 years
Quality of Dying and Death
Quality of Dying and Death for caregivers if patient deceased during study
Measured: 3 years
Symptom Burden
Promis-29 to measure symptom burden in patients at baseline and study completion.
Measured: 3 years
Health Related Quality of Life in IPF
ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start23 Mar 2017
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kathleen O. Lindell, PhD, RN, University of Pittsburgh
- Investigators
- Kathleen O Lindell, PhD, RN, Principal investigator, Dorothy P. and Richard P. Simmons Center for ILD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929017
- Sponsor's protocol ID
- PRO16070539
- Other IDs
- 1K23NR016276-01A1
- Status last verified
- Aug 2020
- First submitted
- 6 Oct 2016
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34003726Lindell 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.
PubMed 29531748
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
- ClinicalTrials.gov ID
- NCT02929017
- Acronym / sponsor ID
- PRO16070539
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Fibrosis, IPF, Caregivers, Pulmonary, Palliative, end of life, Idiopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 10 Oct 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: SUPPORTGroup 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. |
| Usual Care | Other | Other: Currently Available Printed MaterialGroup will receive usual standard-of-care, and be provided with currently available printed material for information about their illness. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| SUPPORTMembers of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist. | Other | Intervention |
| Currently Available Printed MaterialAlso: Usual Standard of CareSubjects will receive their usual standard of care, including currently available printed patient material. | Other | Usual Care |
Primary outcome
Stress
Time frame: 3 years
Perceived Stress Scale at baseline and completion of study in patients and caregivers
6 secondary outcomes
Disease Preparedness
Time frame: 3 years
Knowledge
Time frame: 3 years
Advance Care Planning
Time frame: 3 years
Quality of Dying and Death
Time frame: 3 years
Symptom Burden
Time frame: 3 years
Health Related Quality of Life in IPF
Time frame: 3 years
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 7 Aug 2020.
- Derived from this study: PubMed 34003726Lindell 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.
- Derived from this study: PubMed 29531748Lindell 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.
- 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.
Kathleen O Lindell, PhD, RN principal investigator
Dorothy P. and Richard P. Simmons Center for ILD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPPORT and Currently Available Printed Material in people with Idiopathic Pulmonary Fibrosis, run by University of Pittsburgh 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 4 inclusion and 4 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 7 Aug 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. 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?
Stress (time frame: 3 years). 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 NCT02929017, which also lists 2 linked publications.
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 7 Aug 2020.