COPDNCT05040386
Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT
A study testing EPIC (Empower People to Independence in COPD) in people with COPD, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older Americans. COPD increases in frequency with age, and older adults with COPD often have significant unmet geriatrics-palliative care needs that results in reduced quality of life, high healthcare utilization, and care at the end… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- EPIC (Empower People to Independence in COPD)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to 25 Oct 2024
- Phase
- Interventional
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
- ≥60 years;
- COPD on routinely collected spirometry (FEV1/FVC <0.70 + FEV1<80%);
- Able to speak English;
- At least one of the following:
- 4a) Severe breathlessness as defined by a documented modified Medical Research Council (mMRC) Dyspnea Scale Score >2 in the medical record or any of the following levels of severe breathlessness by medical review: breathless after walking about 100 yards, breathless after a walking few minutes on level ground, or too breathless to leave the house or when dressing); OR, 4b) ≥1 hospitalization in the year prior but >30 days from enrollment; OR, 4c) On supplemental oxygen (exertional or continuous).
- Exclusion criteria (can be excluded for ANY of the following):
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- No access to a dedicated telephone service;
- Recent hospitalization for any reason or exacerbation of COPD in the past 30 days or ongoing exacerbation symptoms requiring treatment with antibiotics and steroids;
- Treated within the past 60 days for an advanced cancer defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, and hematologic malignancies by self report or chart review;
- Active schizophrenia, major depressive disorder, bipolar disorder, suicidal ideations, or substance abuse by self-report or chart review (Active means currently being treated for schizophrenia, bipolar disorder, or suicidal ideations or having active and untreated major depressive disorder, i.e. not under the care of a clinician or not on medications such as antidepressants or mood stabilizers, or having active and untreated substance abuse, i.e. not on medication or enrolled in a substance abuse program);
- Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids);
- Severe cognitive impairment (score ≤3 points on 6-item Callahan Screener): a) Correctly identify current year (1 point); b) Correctly identify current month (1 point); c) Correctly identify current day (1 point); d) Correctly recall "apple" after 5 minutes (1 point); e) Correctly recall "table" after 5 minutes (1 point); f) Correctly recall "penny" after 5 minutes (1 point).
- Care partners
- ≥18 years;
- Self-reporting as "an unpaid spouse or care partner, relative, or friend who knows [the patient] well and is involved in their medical care";
- Able to speak English.
- Exclusion criteria (can be excluded for ANY of the following):
- No access to a dedicated telephone service;
- Active schizophrenia, major depressive disorder, bipolar disorder, suicidal ideation, or substance abuse by self-report (Active schizophrenia, major depressive disorder, bipolar disorder, suicidal ideation, or substance abuse by self-report or chart review (Active means currently being treated for schizophrenia, bipolar disorder, or suicidal ideations or having active and untreated major depressive disorder, i.e. not under the care of a clinician or not on medications such as antidepressants or mood stabilizers, or having active and untreated substance abuse, i.e. not on medication or enrolled in a substance abuse program);
- Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids);
- Severe cognitive impairment (score ≤3 points on a 6-item Callahan screener): a) Correctly identify current year (1 point); b) Correctly identify current month (1 point); c) Correctly identify current day (1 point); d) Correctly recall "apple" after 5 minutes (1 point); e) Correctly recall "table" after 5 minutes (1 point); f) Correctly recall "penny" after 5 minutes (1 point)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Nurse Coach-Led Early Palliative Care for Older Adults With Chronic Obstructive Pulmonary Disease and Their Care Partners: The Project EPIC Pilot Randomized Controlled Trial
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older Americans. COPD increases in frequency with age, and older adults with COPD often have significant unmet geriatrics-palliative care needs that results in reduced quality of life, high healthcare utilization, and care at the end of life that does not align with the values and wishes of patients and their care partners. Older adults with COPD could benefit from proactive geriatrics-palliative care before the end of life. However, no geriatrics-palliative care interventions have been systematically developed and tested in community-dwelling older adults with COPD and their care partners. As the number of older adults with COPD increases to levels unmatched by current palliative care workforce trends, innovative strategies are desperately needed to improve the delivery of geriatrics-palliative care in COPD before the end of life.
Project EPIC (Empowering People to Independence in COPD) is a multiphase study to refine and pilot test the EPIC telephonic nurse coaching intervention in older adults with COPD and their care partners. EPIC is informed by the ENABLE (Educate, Nurture, Advise Before Life Ends) early palliative care intervention that improved quality of life and mood for patients with advanced cancer and has been iteratively refined over decades and rigorous randomized controlled trial testing. In the intervention, palliative care-trained nurse coaches deliver the Charting Your Course Curriculum over the phone to patients (six sessions) and their care partners (four sessions), with activities and monthly telephone follow-up following a manualized curriculum. We conducted a formative evaluation in a diverse and multidisciplinary group of stakeholders to refine ENABLE for patients with COPD and pilot tested the potential feasibility of the refined intervention, EPIC, in patients and their care partners.
The current study summatively evaluates EPIC through a hybrid effectiveness-implementation pilot randomized controlled trial in dyads of community-dwelling older adults with moderate to very severe COPD and their care partners randomized to usual care (control) versus EPIC (intervention). The primary outcomes are intervention feasibility and acceptability. Secondary outcomes include Life-Space mobility, quality of life, cognitive impairment, functional status, palliative care uptake, and care partner burden.
- Conditions
- COPD
- Being tested
- EPIC (Empower People to Independence in COPD), Usual Care
- Keywords
- palliative care, supportive care, caregiver, geriatrics, telehealth, chronic obstructive pulmonary disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIC (Empower People to Independence in COPD)Behavioural
EPIC (Empower People to Independence in COPD) is a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, a rigorously tested multicomponent early palliative care model that improved quality of life and emotional symptoms in patients with advanced cancer. The PI adapted and refined ENABLE for COPD and older adults. EPIC includes weekly (6 for patients and 4 for caregivers) telephone-based, nurse coach-led sessions aided by a manualized curriculum (Charting Your Course), followed by three once-monthly follow up sessions. Participants also complete activities on solving problems and making difficult decisions, complete an Advance Directive, and attend a supportive care clinic visit. Caregiver participants are randomized to the same study arm as the patient participant and receive the caregiver-focused EPIC intervention.
Usual CareOther
Participants randomized to this arm receive standard of care for COPD. This includes routine clinic visits with their clinician, medications, inhalers, vaccinations, tobacco cessation counseling, illness education, cardiopulmonary rehabilitation, specialist referrals, and other COPD therapies deemed appropriate by their clinician. Caregiver participants are randomized to the same study arm as the patient participant.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Patient participants randomized to this arm will receive the standard of care for COPD. Caregiver participants, if available, will be randomized to the same study arm as the patient participant. Receives: Other: Usual Care |
| Intervention (EPIC) | Experimental | Participants randomized to this arm will receive the experimental treatment for COPD (i.e. EPIC). Caregiver participants, if available, will be randomized to the same study arm as the patient participant. Receives: Behavioral: EPIC (Empower People to Independence in COPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
In participants randomized to the intervention arm, we will measure the mean (SD) number of core EPIC patient and caregiver telephonic nurse coaching sessions out of a possible 10 and 8 sessions completed, respectively.
Measured: 6 months
Survey Feasibility
Survey completion rates will be measured and presented as the count of patient and caregiver participants who completed 100% of all available survey sets across the study.
Measured: 6 months
Intervention Acceptability Score
Mean (SD) score on a scale of 1 being very poor and 10 being excellent for the EPIC intervention as rated by patient and caregiver participants randomized to the intervention group.
Measured: 6 months
Count of Acceptability Qualitative Interviews
Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.
Measured: 6 months
Secondary outcomes (10)
UAB Life Space Assessment
The UAB Life Space Assessment is a 15-item measure of Life-Space mobility, or the frequency, distance, and independence of movement in the 4 weeks prior to administration. Scores range from 0 (lowest) to 120 (best), and lower scores are associated with more restricted Life-Space mobility. A threshold score of >=60 is used to identify restricted Life-Space mobility, which is a marker of social isolation, frailty, and predictor of healthcare utilization in older adults. MCID=5 points with an alpha=0.80.
Measured: 6 months
Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item measure of quality of life along 4 domains: CRQ dyspnea, CRQ fatigue, CRQ mastery, and CRQ emotional function. Each domain score ranges from 1 (most severe impairment) to 7 (no impairment). Higher scores are better on each domain, with MCID of 0.5 points and an alpha=0.70. The CRQ Dyspnea Domain has a range of 1 to 7, with higher scores associated with a better outcome. The CRQ Fatigue Domain has a range of 1 to 7, with higher scores associated with better outcome. The CRQ Mastery Domain has a range of 1 to 7, with higher scores associated with better outcome. The CRQ Emotional Function Domain has a range of 1 to 7, with higher scores associated with better outcome.
Measured: 6 months
PROMIS Global Health 10
The PROMIS Global Health 10 is a 10-item measure of quality of life along 2 domains: physical and mental health. There are 9 questions rated on a 5-point Likert-scale, and the 10th question rates pain on a scale of 0 to 10. Raw scores are then converted to standardized t-scores ranging from 0 to 100, with lower scores associated with worse quality of life. PROMIS Global Health Physical Health Domain has a range of 0 to 100, with lower scores associated with worse quality of life. The PROMIS Global Health Mental Health Domain has a range of 0 to 100, with lower scores associated with worse quality of life.
Measured: 6 months
Montgomery Borgatta Caregiver Burden
14-item measure of caregiver burden along 3 domains: objective burden (alpha=0.87-0.90; Range 6 to 30), subjective stress burden (alpha=0.81-0.88; Range 4 to 20), and subjective demand burden (alpha =0.68-0.82; Range 4 to 20). Higher scores are associated with worse outcome on each domain.
Measured: 6 months
Hospital Anxiety and Depression Scale (HADS)
14-item measure of emotional symptoms with a 7-item anxiety subscale and a 7-item depression subscale. Each question has a 4-point Likert scale, and scores from 0-21 per subscale, with higher scores associated with more severe anxiety and depressive symptoms. A subscale score >=8 on each subscale is the accepted threshold for clinically-elevated anxiety or depressive symptoms. The minimal clinically important difference is 1.5 points on each subscale with an alpha=0.82-0.83.
Measured: 6 months
Modified Telephone Interview for Cognitive Status (mTICS)
14-item measure of cognitive impairment, which has been validated in COPD. Scores range from 0-50 with higher scores associated with more cognitive impairment. Validated over telephone (alpha=0.80).
Measured: 6 months
Katz Index of Activities of Daily Living
6-item measure of independence in activities. Range 0-6. Higher scores associated with more independence; MCID=0.47.
Measured: 6 months
Lawton Instrumental Activities of Daily Living
8-item measure of function in independent living, with an MCID=0.47. Scores range from 1 to 8, with higher scores associated with higher functioning. alpha=0.85
Measured: 6 months
Advance Directive Completion
Rates of patient participant Advance Directive completion.
Measured: 6 months
De Jon Gierveld Loneliness Scale
A 6-item measure of loneliness with higher scores associated with more loneliness, range 0 (least lonely) to 6 (most lonely). Alpha=0.88.
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 Sep 2021
- Study start19 May 2022
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Anand Iyer, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040386
- Sponsor's protocol ID
- IRB-300007901
- Other IDs
- K76AG064327
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2021
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byun JY, Wells R, Bechthold AC, Coffee-Dunning J, Armstrong M, Taylor R, O'Hare L, Dransfield MT, Brown CJ, Vance DE, Odom JN, Bakitas M, Iyer AS. Project EPIC (Empowering People to Independence in COPD): Study protocol for a hybrid effectiveness-implementation pilot randomized controlled trial of telephonic, geriatrics-palliative care nurse-coaching in older adults with COPD and their family caregivers. Contemp Clin Trials. 2024 May;140:107487. doi: 10.1016/j.cct.2024.107487. Epub 2024 Mar 6.
PubMed 38458558