Improving Self-care of Heart Failure Caregivers

The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.

Time frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.

Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.

The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.

Time frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.

Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.

Medical Outcomes Study Short Form (SF-36): measure of physical and mental health.The SF-36 has 36 items formatted in scales of varied format (3-, 5- and 6-pt scales and dichotomous \[yes/no\] scales). Each component score is standardized a 0-100 point scale. Higher values represent better health status. Reliability is varied samples is typically 0.80. Convergent and divergent validity have been demonstrated in various populations, including caregivers. A benefit of using the SF-36 is that it is one of the common data elements.

Time frame: Main analysis Baseline to 6 months. Sustainability assessed at 12 months.

Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.

The SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents caregiver quality of life at a given timepoint. Higher SF-6D Scores are better.

Time frame: Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months

The Perceived Stress Scale (PSS), a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress. In prior test, Cronbach's alpha of the scale ranged from 0.84 to 0.86, and was 0.91 for older African American and European American females.

Time frame: Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.

Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.

We used a 30-item modification of the original 42-item questionnaire developed by Lazarus in 1985. We measured these coping styles: active, avoidance, and minimization. The instrument uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-45, 0-30, and 0-30 for the active, avoidance and minimization subscales, respectively. Higher scores indicate greater use of particular coping styles.

Time frame: The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.

Population: Number of participants analyzed differs across timepoints due to participant attrition, missing data due to nonresponse, and/or missed study timepoints.

Healthcare resource use was self-reported by caregivers when they were telephoned at each follow-up period, asking about utilization since the last interview date. The self-reported healthcare use comprised 5 major categories: hospitalizations, emergency department (ED) visits, diagnostic and therapeutic procedures, ambulance services, and home care services. A bottom-up cost account approach was used, wherein the sum of resources times their unit price yielded the total costs associated with healthcare resource use. Unit prices were measured using the 2021 Medical Expenditure Panel Survey (MEPS) (https://meps.ahrq.gov/mepsweb), an annual survey on the financing and use of medical care in the United States collected by the Agency for Healthcare Research and Quality (AHRQ).

Time frame: Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.

Population: At 12-months we had 209 caregivers available for the analysis; 15 were missing healthcare utilization data. We excluded 1 outlier who was in the hospital a long time. Then we had 193 in the final sample. Some of the 193 caregivers included in the analysis skipped one or two or even more follow-up interviews. However, caregivers were asked to report their healthcare utilization since the last follow-up and thus these records were able to be included in analysis.

This measure of quality adjusted life years (QALY) is derived from the SF-36. It was used in the cost-effectiveness analysis. The SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents patient quality of life at a given timepoint, while the QALY represents the area under the curve of patient quality of life from baseline to 12-month timepoints. A QALY value of one equates to one year in perfect health. Higher quality adjusted life years (QALYs) are better.

Time frame: QALYs were measured at baseline, 3, 6, 9, and 12 months. But this analysis focused on the baseline to 12 month period.

Population: 49 patients provided complete SF36 data at both baseline and 12 month timepoints.

For the 93 patients enrolled, the medical record was reviewed to capture hospitalization count. The aim was to explore the effect of caregiver outcomes (self-care) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) will have Lower hospitalization rates. A comparison of patients' hospitalization counts which occurred between 6 and 12 month timepoints was conducted between those caregivers who exhibited a self care improvement from baseline to 6 month timepoint and those caregivers who did not exhibit a self care improvement from the baseline to 6 month timepoint.

Time frame: Count of patient hospitalizations that occurred between 6 and 12 months (following the intervention, which ended at 6 months)

Population: The study sample includes 93 patients total. Because analysis focuses on patient outcomes during months 6 to 12 of the study, 4 patients were excluded from analysis of patient health outcomes due to death occurring between baseline and 6-month study timepoint. Among the remaining 89 enrolled patients, 15 did not provide sufficient data to determine whether self care improved from baseline to six months. Thus, a sample of 74 patients was analyzed.

For the 93 patients enrolled, the medical record was reviewed to capture hospitalization days. The aim was to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) will have Lower hospitalization rates. A comparison of patients' hospitalization days which occurred between 6 and 12 month timepoints was conducted between those caregivers who exhibited a self care improvement from baseline to 6 month timepoint and those caregivers who did not exhibit a self care improvement from the baseline to 6 month timepoint.

Time frame: Count of patient hospitalization days which occurred between 6 and 12 month timepoints

Population: The study sample includes 93 patients total. Because analysis focuses on patient outcomes during months 6 to 12 of the study, 4 patients were excluded from analysis of patient health outcomes due to death occurring between baseline and six month study timepoint. Among the remaining 89 enrolled patients, 15 did not provide sufficient self care data from baseline to six months. Lastly, one outlier was excluded with 148 hospital days in 6 months.A sample of 73 patients was analyzed.

For the 93 patients enrolled, the medical record was reviewed to measure mortality. The aim was to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) would have lower mortality rates. A comparison of patient mortality occurring between 6 and 12 months was conducted between those caregivers who improved in self care during the intervention period (baseline to 6 months) and those caregivers who did not improve in self care.

Time frame: Patient mortality occurring between months 6-12 of the study (following the intervention period)

Population: The study sample includes 93 patients total. Because analysis focuses on patient outcomes during months 6 to 12 of the study, 4 patients were excluded from analysis of patient health outcomes due to death occurring between baseline and six month study timepoint. Among the remaining 89 enrolled patients, 15 did not provide sufficient data to determine whether self care improved from baseline to six months. Thus, a sample of 74 patients was analyzed.