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Table 1 Specific Aims, Hypotheses, with the Outcome Measures for this RCT

From: Study protocol of sustaining home palliative care for patients with Heart Failure (HF) and their family caregivers in rural Appalachia: a mixed methods randomized clinical trial

Primary Aims are to test the outcomes of the HF-FamPALhomeCARE bundled intervention, with patients and family caregivers managing home supportive EOLPC for end-stage HF in rural WV

Aim 1: Compared to the control group at 3, 6, 9 months, and 1-year follow-up:

Hypothesis 1a. The patients in the intervention group will have higher scores on HF-related health quality-of-life measure and on the functional health well-being scale

Hypothesis 1b. The family caregivers in the intervention group will have higher scores on the functional health well-being scale

Aim 2: Compared to the control group at 3, 6, 9 months, and 1-year follow-up:

Hypothesis 2a. The patients in the intervention group will have (a) lower depression and anxiety scores and (b) higher numbers of signed EOL advance directives

Hypothesis 2b. The family caregivers in the intervention group will have (a) lower depression and anxiety scores, (b) lower home caregiving burden scores, and (c) improved home HF EOLPC preparedness and improved home palliative care scores

Secondary Aim (Aim 3) is to assess the bundled intervention helpfulness, cost, and the plans for maintaining the sustainability of our faith community nurses and visiting volunteers engagement across rural WV

Aim 3a. Compare the bundled intervention helpfulness questionnaire ratings by the patient, family caregiver intervention group participants, and the interventionists (faith community nurse and visiting volunteers). Determine the implementation cost of the HF-FamPALhomeCARE bundle

Aim 3b. Using focus group research, determine 10-year plans for sustaining the bundle implementation,

maintaining rural volunteers and coordinating administrative aspects of the program