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| ID | Type | Description | Link |
|---|---|---|---|
| K76AG064327 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPIC (Empower People to Independence in COPD) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 6 months |
| Count of Acceptability Qualitative Interviews | Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Patients
Inclusion criteria (must meet ALL 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):
Care partners
Inclusion criteria (must meet ALL of the following):
Exclusion criteria (can be excluded for ANY of the following):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458558 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (EPIC + Usual Care): Patient Participants | Patient participants randomized to the intervention arm receive the patient-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions. |
| FG001 | Control (Usual Care): Patient Participants | 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. |
| FG002 | Intervention (EPIC + Usual Care): Caregiver Participants | Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive. |
| FG003 | Control (Usual Care): Caregiver Participants | Participants randomized to this arm will receive usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (EPIC + Usual Care): Patient Participants | Patient participants randomized to the intervention arm receive the patient-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This sample represents the total patient and caregiver participants who started the EPIC intervention and completed at least the introductory session. | Posted | Mean | Standard Deviation | Sessions | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (EPIC + Usual Care): Patient Participants | Patient participants randomized to the intervention arm receive the patient-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anand Iyer, MD, MSPH | University of Alabama at Birmingham | 2059341968 | aiyer@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2024 | Oct 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Usual Care | Other | 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. |
|
| 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. | 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. | 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. | 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. | 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). | 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. | 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 | 6 months |
| Advance Directive Completion | Rates of patient participant Advance Directive completion. | 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. | 6 months |
| Lost to Follow-up |
|
| BG001 | Control (Usual Care): Patient Participants | 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. |
| BG002 | Intervention (EPIC + Usual Care): Caregiver Participants | Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive. |
| BG003 | Control (Usual Care): Caregiver Participants | Participants randomized to this arm will receive usual care. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Primary | 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. | Patient and caregiver participants by study arms are analyzed. | Posted | Count of Participants | Participants | 6 months |
|
|
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| Primary | 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. | This represents patient and caregiver participants separately who completed this survey. | Posted | Mean | Standard Deviation | Score on a Scale | 6 months |
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|
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| Primary | Count of Acceptability Qualitative Interviews | Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews. | Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews. | Posted | Count of Participants | Participants | 6 months |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | 6 months |
|
|
|
| Secondary | 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. | Only patient participants completed this instrument. | Posted | Mean | Standard Deviation | Units on a Scale | 6 months |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | 6 months |
|
|
|
| Secondary | 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. | Only caregiver participants were included in the analysis of this outcome. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
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| Secondary | Advance Directive Completion | Rates of patient participant Advance Directive completion. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Usual Care: Patient Participants | Participants randomized to this arm will receive the standard of care for COPD. Usual COPD Care: 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Intervention (EPIC + Usual Care): Caregiver Participants | Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Usual Care: Caregiver Participants | Participants randomized to this arm will receive usual care. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| CRQ Mastery Domain |
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| CRQ Emotional Function Domain |
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| PROMIS Global Health - Mental Health Domain |
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| Subjective Demand Burden Domain |
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| HADS Anxiety Subscale |
|