Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988621
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2019-05-22
Brief Title:
Improving Self-care of Heart Failure Caregivers
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Improving Self-Care of Informal Caregivers of Adults With Heart Failure
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Informal caregiving is demanding and stressful Caregivers of adults with heart failure HF report significant stress and poor self-care Health coaching a support intervention may relieve stress and promote self-care in HF caregivers Few studies have tested the cost-effectiveness of support interventions for caregivers Even less is known about the effect of caregiver support interventions on HF outcomes We have developed and pilot tested a virtual support intervention ViCCY Vicky-Virtual Caregiver Coach for you that we propose to evaluate among HF caregivers Using randomized controlled trial RCT design we will enroll informal HF caregivers with poor self-care Health Self-Care Neglect scale score2 randomizing them 11 to an intervention or control group Both groups will receive standard care augmented with Health Information HI delivered through the Internet but the ViCCY caregiver group will also receive 10 front-loaded coaching support sessions tailored to individual issues The control group will have access to the same HI resources over the same interval using the same Internet program but without coaching support At baseline and 3 6 9 and 12 months we will collect self-reported data on self-care stress coping and health status At 6 months we will compare ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis Our pilot data suggest that addition of support provided by the health coach will make ViCCY more efficacious than HI alone A sample of 250 caregivers 125arm will provide 90 power to detect significant differences between the groups on the primary outcome of self-care Aim 1 We will collect quality adjusted life years QALYs and health care resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY Aim 2 To explore the effect of caregiver outcomes on HF patients outcomes hospitalization rates hospital days mortality rates QALYs over a 12-month period Aim 3 and knowing that not all HF patients will participate we will consent a subgroup of the HF patients cared for by these caregivers at least 40 dyads If shown to be efficacious and cost-effective our virtual health coaching intervention can easily scaled to support millions of caregivers worldwide This application addresses the NINR strategic plan and is directly responsive to PA-18-150
Detailed Description:
We will use a randomized controlled trial RCT design randomizing informal heart failure HF caregivers meeting our inclusion and exclusion criteria 11 to an intervention or control group After collecting baseline data we will block randomize the caregivers to achieve equal distribution of key variables in each condition We will block randomize on caregiver sex malefemale and relationship to patient eg spouse - factors shown to influence perceived caregiving burden and receptivity to intervention The randomization sequence will be 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 will notify the study staff and participants of their group assignment intervention or control by telephone email or message as preferred by the individual Although balance in sample size can be achieved with block randomization the groups may not be fully comparable on other factors Initial comparison of the groups will allow us to control for important covariates in the analyses Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked The nurse providing the intervention and the caregiver participants will not be blinded All baseline data will be collected prior to randomizing Timing of follow-up assessments will be based on day of randomization
The study intervention will be provided to individual caregivers All caregivers both groups will be provided with access to an Internet site with excellent health information HI In addition we have developed and pilot tested a virtual support intervention ViCCY Vicky - Virtual Caregiver Coach for You that we will provide on tablet devices to caregivers in the intervention group We will provide tablets to all the caregivers assuring that they have wireless network access so they can access the Internet site providing HI content Caregivers in the control group will receive only HI but caregivers in the intervention group will receive 10 front-loaded sessions of ViCCY over 6 months
The study intervention will be provided to individual caregivers All caregivers both groups will be provided with access to an Internet site with excellent health information HI In addition we have developed and pilot tested a virtual support intervention ViCCY Vicky - Virtual Caregiver Coach for You that we will provide on tablet devices to caregivers in the intervention group We will provide tablets to all the caregivers assuring that they have wireless network access so they can access the Internet site providing HI content Caregivers in the control group will receive only HI but caregivers in the intervention group will receive 10 front-loaded sessions of ViCCY over 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None