Improving Self-care of Heart Failure Caregivers

We used a randomized controlled trial (RCT) design, randomizing informal heart failure (HF) caregivers meeting our inclusion and exclusion criteria 1:1 to an intervention or control group. After collecting baseline data, we block randomized the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female), relationship to patient (e.g., spouse), and race. Sex and relationship are factors known to influence perceived caregiving burden and receptivity to intervention. Race was included to assure group balance. The randomization sequence was generated a priori by a statistician independent of the study investigators using a randomly permuted blocks algorithm to ensure equal distribution of these variables in each study arm. The Project Manager notified study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Investigators and all staff involved in collecting assessment data were blinded to group assignment until after the data were locked. The health coach providing the intervention and the caregiver participants were not be blinded. All baseline data were collected prior to randomizing. Timing of follow-up assessments were based on day of randomization. The study intervention was provided to individual caregivers. All caregivers (both groups) were provided with access to an Internet site with excellent health information (HI). The virtual support intervention (ViCCY \["Vicky"\] - Virtual Caregiver Coach for You) was provided through tablet devices provided to caregivers in the intervention group. We provided tablets to all the caregivers, assuring that they had wireless network access so they can access the Internet site providing HI content. Caregivers in the control group received only HI but caregivers in the intervention group received 10 sessions of ViCCY over 6 months.

Inclusion Criteria: Informal caregiver of adults with heart failure providing care at least 8 hours/week, reporting poor self-care on screening (Health Self-Care Neglect scale score \>=2 based on our pilot data), able to complete the protocol, e.g., adequate vision and hearing, and English speaking were required for enrollment. Exclusion Criteria: Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\] \<25), Participation in another clinical trial of a support intervention, Untreated major psychiatric illness (Use of anti-anxiety/antidepressant medicines was acceptable and will be adjusted in analysis if group imbalance is identified).