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Table 1 ENABLE CHF-PC randomized controlled trial outcome measures

From: Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial

  Construct Instrument Description of measure Reliability Schedule
Specific aim 1
HF patients QOL Kansas City Cardiomyopathy Questionnaire (KCCQ) 5 domains: physical limitations, symptoms, self-efficacy, social interference, and QOL; 23 items Subscales α =0.62 to 0.90 Baseline + every 8 weeks for 48 weeks
Mood Hospital Anxiety and Depression Scale (HADS) 2 domains measuring depression and anxiety; 14 items Subscales α = 0.82 to 0.83
Symptom burden FACIT-Pal (14-item) 4 domains: physical, social/family, emotional, and functional well-being; 14 items Subscales α = 0.75 to 0.93
PROMIS pain intensity scale; 3-item SF and pain interference (2 items) 3-item PROMIS pain intensity scale; 3 items; patient responses are from 1 (had no pain) to 5 (very severe); PROMIS pain interference; 2 items α = 0.33 to 0.93 (intensity); NA (interfere)
Resource use Patient resource use Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, DNR orders NA
Specific aim 2
Caregivers QOL Bakas Caregiving Outcomes Scale (BCOS) 15-item scale that measures changes in social functioning, subjective well-being, and somatic health of caregiver Subscales α = 0.72 to 0.90 Baseline + every 8 weeks for 48 weeks
Mood HADS (same as above) (same as above)
Caregiver burden Montgomery Borgatta Caregiver Burden Scale Measure of caregiver burden with 3 domains: objective burden, stress burden, and demand burden; 14 items Subscales α = 0.75 to 0.88
Positive Aspects of Caregiving (PAC) Measure of caregiver’s mental–affective state in relation to the caregiving experience; 9 items Subscales α = 0.85 to 0.88
Exploratory aims
HF patients Activation Patient Assessment of Chronic Illness Care (PACIC) 5 dimensions: activation, delivery system/decision support, goal-setting, problem-solving, and coordination; 20 items Subscales α = 0.62 to 0.90 Baseline + every 8 weeks for 48 weeks
Coping style Brief cope 2 subscales: active and avoidant coping; 28 items α = 0.68 to 0.79 Baseline only
Social support Multidimensional Scale of Perceived Social Support (MSPSS) Perceived adequacy of support from family and friends; 12 items α = 0.81 Baseline only
Both Health literacy Rapid Estimate of Adult Literacy in Medicine Measure of health literacy and numeracy based on ability to recognize common health-related terms; 7 items α > 0.80 Baseline only
Self-reported health PROMIS SF Global Health 10 2 domains: physical and mental health; 10 items Subscales α = 0.81 to 0.86 Baseline + every 8 weeks for 48 weeks
Demographics Demographic questionnaire Age, gender, race, marital status, religion, education, occupation, health insurance, smoking, etc. NA Baseline only
Spiritual and religious coping Brief multidimensional measure of religiousness and spirituality Assesses two patterns of religious and spiritual coping with stressful life events: positive religious and spiritual coping reflective of benevolent religious methods of understanding and dealing with life stressors; and negative religious and spiritual coping reflective of religious struggle in coping; 7 items Subscale α = 0.83 Baseline + every 8 weeks for 48 weeks
Reciprocal relationships Dyadic HF care typology Four basic categories of typology for dyad NA Baseline only
Dyadic adjustment scale- SF Measures degree of agreement on relational factors such as shared philosophy, goals and time spent together; 7 items Subscales for patients: α = 0.70; for caregivers: α = 0.78 Baseline + every 8 weeks for 48 weeks
  1. QOL quality of life, BCOS Bakas Caregiving Outcomes Scale, NA not applicable, FACIT-Pal Functional Assessment of Chronic Illness Therapy: Palliative Care, HADS Hospital Anxiety and Depression Scale, HF heart failure, ICU intensive care unit, KCCQ Kansas City Cardiomyopathy Questionnaire, ED emergency department, AD advance directive, DNR do not resuscitate, MSPSS Multidimensional Scale of Perceived Social Support, PAC Positive Aspects of Caregiving, PACIC Patient Assessment of Chronic Illness Care, PROMIS Patient-Reported Health Outcome Measures Global Health, SF Short Form