Lung DiseasesNCT03813667
Palliative Care Coaching for Families With Rare Advanced Lung Diseases
A study testing Intervention FamPALcare in people with Lung Diseases and Rare Non-Neoplastic Disorder, run by West Virginia University at 1 site in United States.
Trial summary
With one of the highest incidences of lung disease deaths in the nation, there is great need for home end-of-life palliative care in the rural, disadvantaged communities of West Virginia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Rare Non-Neoplastic Disorder
- What is being tested?
- Intervention FamPALcare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Sep 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
- Adult patients diagnosed with R-ALD, and their primary family caregivers dyad.
- All participants must be alert and oriented.
- Be able to read and write in English.
Who cannot join
- Patients who have received or are on a waiting list for a lung transplant
- Patients diagnosed with another terminal illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospital
Morgantown, West Virginia, 26506
About this study
Official title: Palliative Care Coaching for Family Caregivers & Patients With Rare Advanced Lung Disease
With one of the highest incidences of lung disease deaths in the nation, there is great need for home end-of-life palliative care in the rural, disadvantaged communities of West Virginia. The aims of this proposed study are to: (1) pilot test the nursing care intervention with patients and family members managing home supportive EOLPC for rare advanced lung disease and (2) collect research data to report in the NIH resubmission and future trials.
Read the detailed description
Nearly 15 million Americans and greater than 10% of West Virginia (WV) residents live with and eventually die from Rare and Advanced Lung Diseases (R-ALD), including pneumoconiosis (i.e., dust, asbestos), and idiopathic pulmonary fibrosis. Patients with R-ALD experience refractory breathlessness, depression, fatigue, and extreme worry about their family members and cost of health care. With one of the highest incidences of lung disease deaths in the nation, there is great need for home EOLPC in the rural, disadvantaged communities of WV. The proposed EOLPC intervention (FamPALcare) is based on R-ALD experts' input, national EOLPC guidelines, and the PI's published EOLPC studies with breathlessness in end-stage heart failure (HF) patients.
This project is well-aligned with the National Institutes of Health (NIH) priority specific to "Appalachian populations experiencing extreme inequities and poor access to healthcare" and the NIH PAR on palliative care for family caregivers and patients with advanced lung diseases. The PI's NIH application review, which received a positive score, stated that this project will have a high impact on improving palliative care for rural families managing lung disease and the project can be translated to other rural communities. This is an initial study of coaching home-based palliative R-ALD care in rural Appalachia. The NIH review stated using the PI's culturally sensitive approaches for R-ALD was novel for chronic lung disease. Also, addressing both family caregivers' and patients' needs was noted as innovative and increased the potential for future funding, as was the rigorous protocol for observing intervention fidelity.
This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregiver. Specific aims are to: (1) pilot test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for R-ALD and (2) collect research data to report in the PI's NIH resubmission and future trials. The control patients receive standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist, and recorded in the medical record. The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in EOLPC. Data will be collected at baseline, month one, and month three from patients and caregivers independently. This pilot study provides testing of our research guides and procedures that will be described to enhance the NIH resubmission and will determine power needed for the future RCT design.
- Conditions
- Lung Diseases, Rare Non-Neoplastic Disorder
- Being tested
- Intervention FamPALcare
- Keywords
- advanced lung diseases, Palliative Care, Dyspnea, pilot projects, Terminal Care
- Medical subject headings
- Lung Diseases, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention FamPALcareBehavioural
Also called FamPALcare
The FamPALcare intervention includes all standard care information on R-ALD home care plus 2 weeks of EOLPC coaching by community nurses experienced in EOLPC. The nurse uses the "Conversation Ready" pamphlet to guide discussion of EOL preferences. The nurse will: (1) support the patient and family in making decisions about EOL care options based on their preferences; (2) discuss options for EOL care when the patient's R-ALD symptoms become severe; (3) encourage completion of the advance directive forms at next physician appointment. The nurse will use "teach-back" processes to ensure that FamPALcare discussions are clear.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control patients have standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist and recorded in the medical record |
| Intervention | Experimental | The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in end-of-life palliative care. Receives: Behavioral: Intervention FamPALcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient outcomes
The intervention group R-ALD patients will report lower scores on breathlessness scale compared to control group patients at 3 months.
Breathlessness is measured by Self-report shortness of breath scale (1 item, 0-10; 0-no shortness of breath, 10 = shortness of breath as bad as can be) (Gift, Narsavage, 1998
Measured: 3 months
Secondary outcomes (3)
family caregiver outcomes
The intervention group family caregivers will rate lower scores on Anxiety and Depression on PHQ-4 Scale compared to control group caregivers at 3 months.
Anxiety and Depression are measured by PHQ-4 Scale, 4-item Likert scale.
Measured: 3 months
patients' decision on EOLPC
The intervention group will report higher numbers of signed advance directives.
This outcome is measured by the presence of signed advance directives in the medical record. Various types of advance directives will be identified.
Measured: 3 months
Helpfulness of home R-ALD EOLPC intervention
Each patient and family member will rate the 11-item Likert Intervention on the Helpfulness scale at 3 months. Range 1-5, 1= strongly disagree/not helpful and 5 = strong agree/helpful.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Nov 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 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 Lung DiseasesStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Model description
- This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregivers.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ubolrat Piamjariyakul, West Virginia University
- Investigators
- Ubolrat Piamjariyakul, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813667
- Sponsor's protocol ID
- 1703528067
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot RCT, the researchers do not want to share the IPD.
Publications
Piamjariyakul U, Smothers A, Young S, Petitte T, Wen S, Morrissey E, Shafique S, Zulfikar R, Sangani R, Smith CE. Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial. J Adv Nurs. 2020 Aug;76(8):2182-2190. doi: 10.1111/jan.14395. Epub 2020 May 2.
PubMed 32297352
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Coaching for Family Caregivers & Patients With Rare Advanced Lung Disease
- ClinicalTrials.gov ID
- NCT03813667
- Acronym / sponsor ID
- 1703528067
- Conditions
- Lung Diseases, Rare Non-Neoplastic Disorder
- Keywords
- advanced lung diseases, Palliative Care, Dyspnea, pilot projects, Terminal Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Jan 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.
With one of the highest incidences of lung disease deaths in the nation, there is great need for home end-of-life palliative care in the rural, disadvantaged communities of West Virginia. The aims of this proposed study are to: (1) pilot test the nursing care intervention with patients and family members managing home supportive EOLPC for rare advanced lung disease and (2) collect research data to report in the NIH resubmission and future trials.
Detailed description
Nearly 15 million Americans and greater than 10% of West Virginia (WV) residents live with and eventually die from Rare and Advanced Lung Diseases (R-ALD), including pneumoconiosis (i.e., dust, asbestos), and idiopathic pulmonary fibrosis. Patients with R-ALD experience refractory breathlessness, depression, fatigue, and extreme worry about their family members and cost of health care. With one of the highest incidences of lung disease deaths in the nation, there is great need for home EOLPC in the rural, disadvantaged communities of WV. The proposed EOLPC intervention (FamPALcare) is based on R-ALD experts' input, national EOLPC guidelines, and the PI's published EOLPC studies with breathlessness in end-stage heart failure (HF) patients.
This project is well-aligned with the National Institutes of Health (NIH) priority specific to "Appalachian populations experiencing extreme inequities and poor access to healthcare" and the NIH PAR on palliative care for family caregivers and patients with advanced lung diseases. The PI's NIH application review, which received a positive score, stated that this project will have a high impact on improving palliative care for rural families managing lung disease and the project can be translated to other rural communities. This is an initial study of coaching home-based palliative R-ALD care in rural Appalachia. The NIH review stated using the PI's culturally sensitive approaches for R-ALD was novel for chronic lung disease. Also, addressing both family caregivers' and patients' needs was noted as innovative and increased the potential for future funding, as was the rigorous protocol for observing intervention fidelity.
This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregiver. Specific aims are to: (1) pilot test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for R-ALD and (2) collect research data to report in the PI's NIH resubmission and future trials. The control patients receive standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist, and recorded in the medical record. The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in EOLPC. Data will be collected at baseline, month one, and month three from patients and caregivers independently. This pilot study provides testing of our research guides and procedures that will be described to enhance the NIH resubmission and will determine power needed for the future RCT design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregivers.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control patients have standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist and recorded in the medical record |
| Intervention | Experimental | Behavioral: Intervention FamPALcareThe FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in end-of-life palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients diagnosed with R-ALD, and their primary family caregivers dyad.
- All participants must be alert and oriented.
- Be able to read and write in English.
Key exclusion criteria (2 listed)
- Patients who have received or are on a waiting list for a lung transplant
- Patients diagnosed with another terminal illness.
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 |
|---|---|---|
| Intervention FamPALcareAlso: FamPALcareThe FamPALcare intervention includes all standard care information on R-ALD home care plus 2 weeks of EOLPC coaching by community nurses experienced in EOLPC. The nurse uses the "Conversation Ready" pamphlet to guide discussion of EOL preferences. The nurse will: (1) support the patient and family in making decisions about EOL care options based on their preferences; (2) discuss options for EOL care when the patient's R-ALD symptoms become severe; (3) encourage completion of the advance directive forms at next physician appointment. The nurse will use "teach-back" processes to ensure that FamPALcare discussions are clear. | Behavioural | Intervention |
Primary outcome
patient outcomes
Time frame: 3 months
The intervention group R-ALD patients will report lower scores on breathlessness scale compared to control group patients at 3 months. Breathlessness is measured by Self-report shortness of breath scale (1 item, 0-10; 0-no shortness of breath, 10 = shortness of breath as bad as can be) (Gift, Narsavage, 1998
3 secondary outcomes
family caregiver outcomes
Time frame: 3 months
patients' decision on EOLPC
Time frame: 3 months
Helpfulness of home R-ALD EOLPC intervention
Time frame: 3 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 21 Oct 2019.
- Derived from this study: PubMed 32297352Piamjariyakul U, Smothers A, Young S, Petitte T, Wen S, Morrissey E, Shafique S, Zulfikar R, Sangani R, Smith CE. Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial. J Adv Nurs. 2020 Aug;76(8):2182-2190. doi: 10.1111/jan.14395. Epub 2020 May 2.
- Individual participant dataSharing planned: No. This is a pilot RCT, the researchers do not want to share the IPD.
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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.
Ubolrat Piamjariyakul, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention FamPALcare in people with Lung Diseases and Rare Non-Neoplastic Disorder, run by West Virginia University 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 3 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 21 Oct 2019. 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?
patient outcomes (time frame: 3 months). 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 NCT03813667, 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 21 Oct 2019.