COPD
Conditions
Keywords
palliative care, supportive care, caregiver, geriatrics, telehealth, chronic obstructive pulmonary disease, COPD
Brief 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 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.
Interventions
BEHAVIORALEPIC (Empower People to Independence in COPD)
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.
OTHERUsual 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. Caregiver participants are randomized to the same study arm as the patient participant.
Sponsors
National Institute on Aging (NIA)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients Inclusion criteria (must meet ALL of the following): 1. ≥60 years; 2. COPD on routinely collected spirometry (FEV1/FVC \<0.70 + FEV1\<80%); 3. Able to speak English; 4. 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): 1. No access to a dedicated telephone service; 2. Recent hospitalization for any reason or exacerbation of COPD in the past 30 days or ongoing exacerbation symptoms requiring treatment with antibiotics and steroids; 3. 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; 4. 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); 5. Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids); 6. 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 Inclusion criteria (must meet ALL of the following): 1. ≥18 years; 2. Self-reporting as an unpaid spouse or care partner, relative, or friend who knows \[the patient\] well and is involved in their medical care; 3. Able to speak English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility | 6 months | 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. |
| Survey Feasibility | 6 months | 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. |
| Intervention Acceptability Score | 6 months | 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. |
| Count of Acceptability Qualitative Interviews | 6 months | Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | 6 months | 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. |
| Modified Telephone Interview for Cognitive Status (mTICS) | 6 months | 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). |
| Katz Index of Activities of Daily Living | 6 months | 6-item measure of independence in activities. Range 0-6. Higher scores associated with more independence; MCID=0.47. |
| UAB Life Space Assessment | 6 months | 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. |
| Advance Directive Completion | 6 months | Rates of patient participant Advance Directive completion. |
| De Jon Gierveld Loneliness Scale | 6 months | A 6-item measure of loneliness with higher scores associated with more loneliness, range 0 (least lonely) to 6 (most lonely). Alpha=0.88. |
| Lawton Instrumental Activities of Daily Living | 6 months | 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 |
| Chronic Respiratory Questionnaire (CRQ) | 6 months | 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. |
| PROMIS Global Health 10 | 6 months | 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. |
| Montgomery Borgatta Caregiver Burden | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| 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. | 10 |
| Control (Usual Care): Caregiver Participants Participants randomized to this arm will receive usual care. | 10 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Control (Usual Care): Patient Participants | Intervention (EPIC + Usual Care): Caregiver Participants | Control (Usual Care): Caregiver Participants | Total | Intervention (EPIC + Usual Care): Patient Participants |
|---|---|---|---|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 8.1 | 64.3 years STANDARD_DEVIATION 15.8 | 62.6 years STANDARD_DEVIATION 6.1 | 67.9 years STANDARD_DEVIATION 11.9 | 70.5 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 6 Participants | 9 Participants | 36 Participants | 9 Participants |
| Region of Enrollment United States | 15 participants | 10 participants | 10 participants | 50 participants | 15 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 9 Participants | 32 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 1 Participants | 18 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Count of Acceptability Qualitative Interviews
Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.
Time frame: 6 months
Population: Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (EPIC + Usual Care) | Count of Acceptability Qualitative Interviews | 12 Participants |
| Control (Usual Care): Patient Participants | Count of Acceptability Qualitative Interviews | 12 Participants |
| Intervention (EPIC): Caregiver Participants | Count of Acceptability Qualitative Interviews | 6 Participants |
| Control (Usual Care): Caregiver Participants | Count of Acceptability Qualitative Interviews | 7 Participants |
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.
Time frame: 6 months
Population: This represents patient and caregiver participants separately who completed this survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (EPIC + Usual Care) | Intervention Acceptability Score | 9.8 Score on a Scale | Standard Deviation 0.4 |
| Control (Usual Care): Patient Participants | Intervention Acceptability Score | 9.9 Score on a Scale | Standard Deviation 0.4 |
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.
Time frame: 6 months
Population: This sample represents the total patient and caregiver participants who started the EPIC intervention and completed at least the introductory session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (EPIC + Usual Care) | Intervention Feasibility | Mean (SD) Patient Core EPIC Sessions | 9.2 Sessions | Standard Deviation 2.4 |
| Intervention (EPIC + Usual Care) | Intervention Feasibility | Mean (SD) Caregiver Core EPIC Sessions | 6.4 Sessions | Standard Deviation 2.7 |
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.
Time frame: 6 months
Population: Patient and caregiver participants by study arms are analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (EPIC + Usual Care) | Survey Feasibility | 12 Participants |
| Control (Usual Care): Patient Participants | Survey Feasibility | 12 Participants |
| Intervention (EPIC): Caregiver Participants | Survey Feasibility | 6 Participants |
| Control (Usual Care): Caregiver Participants | Survey Feasibility | 8 Participants |
Secondary
Advance Directive Completion
Rates of patient participant Advance Directive completion.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (EPIC + Usual Care) | Advance Directive Completion | 7 Participants |
| Control (Usual Care): Patient Participants | Advance Directive Completion | 5 Participants |
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.
Time frame: 6 months
Population: Only patient participants completed this instrument.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (EPIC + Usual Care) | Chronic Respiratory Questionnaire (CRQ) | CRQ Dyspnea Domain | 4.0 Units on a Scale | Standard Deviation 1.7 |
| Intervention (EPIC + Usual Care) | Chronic Respiratory Questionnaire (CRQ) | CRQ Fatigue Domain | 3.4 Units on a Scale | Standard Deviation 1.7 |
| Intervention (EPIC + Usual Care) | Chronic Respiratory Questionnaire (CRQ) | CRQ Mastery Domain | 5.0 Units on a Scale | Standard Deviation 1.4 |
| Intervention (EPIC + Usual Care) | Chronic Respiratory Questionnaire (CRQ) | CRQ Emotional Function Domain | 4.7 Units on a Scale | Standard Deviation 1.7 |
| Control (Usual Care): Patient Participants | Chronic Respiratory Questionnaire (CRQ) | CRQ Emotional Function Domain | 4.9 Units on a Scale | Standard Deviation 1.6 |
| Control (Usual Care): Patient Participants | Chronic Respiratory Questionnaire (CRQ) | CRQ Dyspnea Domain | 3.9 Units on a Scale | Standard Deviation 1.7 |
| Control (Usual Care): Patient Participants | Chronic Respiratory Questionnaire (CRQ) | CRQ Mastery Domain | 4.5 Units on a Scale | Standard Deviation 1.5 |
| Control (Usual Care): Patient Participants | Chronic Respiratory Questionnaire (CRQ) | CRQ Fatigue Domain | 3.5 Units on a Scale | Standard Deviation 1.5 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (EPIC + Usual Care) | De Jon Gierveld Loneliness Scale | 1.8 Units on a scale | Standard Deviation 1.4 |
| Control (Usual Care): Patient Participants | De Jon Gierveld Loneliness Scale | 2.6 Units on a scale | Standard Deviation 2.1 |
| Intervention (EPIC): Caregiver Participants | De Jon Gierveld Loneliness Scale | 1.1 Units on a scale | Standard Deviation 1.6 |
| Control (Usual Care): Caregiver Participants | De Jon Gierveld Loneliness Scale | 0.8 Units on a scale | Standard Deviation 1.3 |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (EPIC + Usual Care) | Hospital Anxiety and Depression Scale (HADS) | HADS Anxiety Subscale | 5.1 Units on a scale | Standard Deviation 3.2 |
| Intervention (EPIC + Usual Care) | Hospital Anxiety and Depression Scale (HADS) | HADS Depression Subscale | 6.4 Units on a scale | Standard Deviation 3.3 |
| Control (Usual Care): Patient Participants | Hospital Anxiety and Depression Scale (HADS) | HADS Depression Subscale | 8.3 Units on a scale | Standard Deviation 5.3 |
| Control (Usual Care): Patient Participants | Hospital Anxiety and Depression Scale (HADS) | HADS Anxiety Subscale | 6.6 Units on a scale | Standard Deviation 4.3 |
| Intervention (EPIC): Caregiver Participants | Hospital Anxiety and Depression Scale (HADS) | HADS Depression Subscale | 2.5 Units on a scale | Standard Deviation 1.9 |
| Intervention (EPIC): Caregiver Participants | Hospital Anxiety and Depression Scale (HADS) | HADS Anxiety Subscale | 2.5 Units on a scale | Standard Deviation 1.8 |
| Control (Usual Care): Caregiver Participants | Hospital Anxiety and Depression Scale (HADS) | HADS Anxiety Subscale | 3.4 Units on a scale | Standard Deviation 2.2 |
| Control (Usual Care): Caregiver Participants | Hospital Anxiety and Depression Scale (HADS) | HADS Depression Subscale | 2.6 Units on a scale | Standard Deviation 1.7 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (EPIC + Usual Care) | Katz Index of Activities of Daily Living | 5.7 Units on a scale | Standard Deviation 0.7 |
| Control (Usual Care): Patient Participants | Katz Index of Activities of Daily Living | 5.3 Units on a scale | Standard Deviation 1.6 |
| Intervention (EPIC): Caregiver Participants | Katz Index of Activities of Daily Living | 6.0 Units on a scale | Standard Deviation 0 |
| Control (Usual Care): Caregiver Participants | Katz Index of Activities of Daily Living | 6.0 Units on a scale | Standard Deviation 0 |
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (EPIC + Usual Care) | Lawton Instrumental Activities of Daily Living | 5.0 Units on a scale | Standard Deviation 2 |
| Control (Usual Care): Patient Participants | Lawton Instrumental Activities of Daily Living | 5.7 Units on a scale | Standard Deviation 1.8 |
| Intervention (EPIC): Caregiver Participants | Lawton Instrumental Activities of Daily Living | 7.0 Units on a scale | Standard Deviation 1.4 |
| Control (Usual Care): Caregiver Participants | Lawton Instrumental Activities of Daily Living | 7.7 Units on a scale | Standard Deviation 1.9 |
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).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (EPIC + Usual Care) | Modified Telephone Interview for Cognitive Status (mTICS) | 28.6 Units on a scale | Standard Deviation 4.4 |
| Control (Usual Care): Patient Participants | Modified Telephone Interview for Cognitive Status (mTICS) | 31.7 Units on a scale | Standard Deviation 6.6 |
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.
Time frame: 6 months
Population: Only caregiver participants were included in the analysis of this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (EPIC + Usual Care) | Montgomery Borgatta Caregiver Burden | Objective Burden Domain | 19.3 Units on a scale | Standard Deviation 2.4 |
| Intervention (EPIC + Usual Care) | Montgomery Borgatta Caregiver Burden | Subjective Stress Burden Domain | 12.4 Units on a scale | Standard Deviation 0.9 |
| Intervention (EPIC + Usual Care) | Montgomery Borgatta Caregiver Burden | Subjective Demand Burden Domain | 11.5 Units on a scale | Standard Deviation 1.7 |
| Control (Usual Care): Patient Participants | Montgomery Borgatta Caregiver Burden | Subjective Demand Burden Domain | 12.1 Units on a scale | Standard Deviation 1.8 |
| Control (Usual Care): Patient Participants | Montgomery Borgatta Caregiver Burden | Objective Burden Domain | 20.9 Units on a scale | Standard Deviation 3.4 |
| Control (Usual Care): Patient Participants | Montgomery Borgatta Caregiver Burden | Subjective Stress Burden Domain | 12.9 Units on a scale | Standard Deviation 1.9 |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (EPIC + Usual Care) | PROMIS Global Health 10 | PROMIS Global Health - Physical Health Domain | 36.5 Units on a Scale | Standard Deviation 6.1 |
| Intervention (EPIC + Usual Care) | PROMIS Global Health 10 | PROMIS Global Health - Mental Health Domain | 45.8 Units on a Scale | Standard Deviation 8.3 |
| Control (Usual Care): Patient Participants | PROMIS Global Health 10 | PROMIS Global Health - Mental Health Domain | 40.5 Units on a Scale | Standard Deviation 9.7 |
| Control (Usual Care): Patient Participants | PROMIS Global Health 10 | PROMIS Global Health - Physical Health Domain | 35.5 Units on a Scale | Standard Deviation 8.3 |
| Intervention (EPIC): Caregiver Participants | PROMIS Global Health 10 | PROMIS Global Health - Physical Health Domain | 52.2 Units on a Scale | Standard Deviation 8.9 |
| Intervention (EPIC): Caregiver Participants | PROMIS Global Health 10 | PROMIS Global Health - Mental Health Domain | 56.6 Units on a Scale | Standard Deviation 5.7 |
| Control (Usual Care): Caregiver Participants | PROMIS Global Health 10 | PROMIS Global Health - Physical Health Domain | 51.1 Units on a Scale | Standard Deviation 5.5 |
| Control (Usual Care): Caregiver Participants | PROMIS Global Health 10 | PROMIS Global Health - Mental Health Domain | 56.0 Units on a Scale | Standard Deviation 8.7 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (EPIC + Usual Care) | UAB Life Space Assessment | 46.6 Units on a Scale | Standard Deviation 20.3 |
| Control (Usual Care): Patient Participants | UAB Life Space Assessment | 52.1 Units on a Scale | Standard Deviation 29.1 |
| Intervention (EPIC): Caregiver Participants | UAB Life Space Assessment | 100.5 Units on a Scale | Standard Deviation 21.9 |
| Control (Usual Care): Caregiver Participants | UAB Life Space Assessment | 90.3 Units on a Scale | Standard Deviation 17.6 |