Table 1 ENABLE CHF-PC randomized controlled trial outcome measures
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 | ||