Clinical trial NCT01600131: RESCUE Stroke Caregiver Website to Enhance Discharge Planning
Official title: Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Quality of Life
Self Efficacy
Recovery of Function
Stress
Positive Aspects of Caregiving
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-05-16
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims and Intervention:

The long-term goal is to implement stroke caregiver programs that involve low-cost interventions that are sustainable in routine clinical practice. The immediate objective is to test, using a randomized controlled trial, a problem-solving intervention for stroke caregivers that can be delivered during the transitional care period (e.g., time which Veteran is discharged to home) followed by online, in-home sessions. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on previously developed and nationally available RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also provide on-line, skills training and application of the problem-solving approach via the RESCUE messaging center. The immediate, primary aim (#1) is to test the effect of the intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline data collection. Aim #2 is to test the effect of the intervention on stroke caregivers' burden, positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and satisfaction with care at 11 and 19 weeks after baseline data collection. Aim #3 is to test the effect of the intervention on Veterans' outcomes: functional abilities and healthcare utilization (i.e., unintended hospital bed days of care, number of emergency room visits, number of unscheduled clinic visits) at 11 and 19 weeks after baseline data collection. Aim #4 is to determine the budgetary impact for implementing the intervention. Aim #5 is to determine the facilitators, barriers and best practices for implementing the intervention.

Design and Methods:

The investigators will conduct a two-group randomized controlled trial. The investigators will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia Veterans Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa, Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central Arkansas Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and then be randomized to two groups: 1) intervention group, or 2) standard care. A team member will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to answer questions on instruments with established reliability and validity. Qualitative interviews will be conducted with selected caregivers to obtain in-depth perceptions of the value, facilitators, and barriers of the intervention.

Impact:

This is the first known study to test a transition-to-home intervention combined with technology to improve the quality of caregiving and the recovery of Veterans.

Detailed description: Background:

Caregiver depression is common following a family member's stroke and is a major contributor of survivor's hospital readmission and institutionalization. Researchers have consistently found that interventions to help caregivers resolve problems are effective in reducing depressive symptoms. However, these problem-solving interventions have been underused in practice because they involve multiple, in-person or telephone sessions and require large amounts of staff time to implement. To overcome these barriers, the long-term goal is to implement stroke caregiver programs that involve low-cost interventions that are sustainable in routine clinical practice. The immediate objective is to test, using a randomized controlled trial, a problem-solving intervention for stroke caregivers that can be delivered shortly after the Veterans' in-patient stays followed by online, in-home sessions. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on previously developed and nationally available RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also provide on-line, skills training and application of the problem-solving approach via the RESCUE messaging center, a secure site behind the VA firewall. This work builds on the team's extensive experience in stroke caregiver education.

The immediate, primary aim (#1) is to test the effect of the intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline data collection. Primary Hypothesis: Stroke caregivers who receive the intervention will have less depressive symptoms at 11 and 19 weeks after baseline data collection compared to stroke caregivers who receive standard care. The investigators propose four secondary aims. Aim #2 is to test the effect of the intervention on stroke caregivers' burden, positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and satisfaction with care at 11 and 19 weeks after baseline data collection. Aim #3 is to test the effect of the intervention on Veterans' outcomes: functional abilities and healthcare utilization (i.e., unintended hospital bed days of care, number of emergency room visits, number of unscheduled clinic visits) at 11 and 19 weeks after baseline data collection. Aim #4 is to determine the budgetary impact for implementing the intervention. Aim #5 is to determine the facilitators, barriers and best practices for implementing the intervention.

Methods:

The investigators will conduct a two-group randomized controlled trial with repeated measures and use mixed methods to determine caregivers' perceptions of the intervention. The investigators will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia Veterans Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa, Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central Arkansas Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and then be randomized to two groups: 1) intervention group, or 2) standard care. A study team member will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to answer questions on instruments with established reliability and validity. The team member will review the Veterans' VA Computerized Patient Record System health record to obtain information on the Veterans' healthcare utilization. The investigators will determine the budgetary impact of the intervention by examining the cost data in the VA Managerial Cost Accounting System (MCAS) (formerly DSS) National Data Extracts and Non-VA Medical Care files. Qualitative interviews will be conducted with selected caregivers to obtain in-depth perceptions of the value, facilitators, and barriers of the intervention. Throughout all phases of the project, the investigators will collaborate with VA (Offices of Nursing Service and Office of Geriatrics and Extended Care.

Impact:

This is the first known study to test transition-to-home intervention combined with technology to improve the quality of caregiving and the recovery of Veterans. Other outcomes will be a state-of-the-art website and an evidence-based model (in-patient, discharge planning and online, training and caregiver-provider messaging) that can be transportable to other disease models

Eligibility criteria: Inclusion Criteria:

All caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria:

* are the primary caregiver and provide the majority of care for a Veteran who has a primary diagnosis of stroke (ICD9 codes for stroke: 430-438) and who has at least one activity of daily living (ADL) deficits or a new or worsening cognitive or physical functioning problem,
* have Internet and email access and ability,
* are reachable by cell or home phone,
* read English at the sixth grade reading level or better,
* score 1 or greater on the Perceived Stress Scale
* Veteran has been discharged to home within the preceding four months or plans to be ultimately discharged to home
* are agreeable to be randomized to the intervention or standard care group

Exclusion Criteria:

Caregivers who fail to meet one or more of the inclusion criteria and whose Veterans

* are terminally ill
* have a life expectancy of less than 6 months
* are a prisoner, or
* are professional caregivers who had no preexisting relationship to the Veteran
* are enrolled or have completed similar caregiving interventions (at PI discretion)

Life expectancy and service use will be determined by reviewing the CPRS records and conferring with the in-patient staff and with the investigators' clinical team members (MDs, RNs).

Primary outcomes:
measure: Change in Depressive Symptoms at 11 Weeks
timeFrame: 11 weeks after baseline
measure: Change in Depressive Symptoms at 19 Weeks
timeFrame: 19 weeks after baseline
measure: Change in Caregiver Burden - Zarit
timeFrame: 11 weeks after baseline
measure: Change in Caregiver Burden - Zarit
timeFrame: 19 weeks after baseline
measure: Change in Caregiver Burden - Time Required
timeFrame: 11 weeks after baseline
measure: Change in Caregiver Burden - Time Required
timeFrame: 19 weeks after baseline
measure: Change in Caregiver Burden - Task Difficulty
timeFrame: 11 weeks after baseline
measure: Change in Caregiver Burden - Task Difficulty
timeFrame: 19 weeks after baseline
Secondary outcomes:
measure: Change in Perceived Stress
timeFrame: 11 weeks after baseline
measure: Change in Perceived Stress
timeFrame: 19 weeks after baseline
measure: Change in Positive Perceptions of Caregiving
timeFrame: 11 weeks after baseline
measure: Change in Positive Perceptions of Caregiving
timeFrame: 19 weeks after baseline
measure: Change in Stroke Knowledge
timeFrame: 11 weeks after baseline
measure: Change in Stroke Knowledge
timeFrame: 19 weeks after baseline
measure: Change in General Patient Satisfaction
timeFrame: 11 weeks after baseline
measure: Change in General Patient Satisfaction
timeFrame: 19 weeks after baseline
measure: Change in Veteran Functional Status
timeFrame: 11 weeks after baseline
measure: Change in Veteran Functional Status
timeFrame: 19 weeks after baseline
measure: Change in Self-efficacy - Obtaining Respite
timeFrame: 11 weeks after baseline
measure: Change in Self-efficacy - Obtaining Respite
timeFrame: 19 weeks after baseline
measure: Change in Self-efficacy - Controlling Upsetting Thoughts
timeFrame: 11 weeks after baseline
measure: Change in Self-efficacy - Controlling Upsetting Thoughts
timeFrame: 19 weeks after baseline
measure: Change in Health-Related Quality of Life - Physical
timeFrame: 11 weeks after baseline
measure: Change in Health-Related Quality of Life - Physical
timeFrame: 19 weeks after baseline
measure: Change in Health-Related Quality of Life - Mental Health
timeFrame: 11 weeks after baseline
measure: Change in Health-Related Quality of Life - Mental Health
timeFrame: 19 weeks after baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System, Miami, FL
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Constance R. Uphold, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graf R, LeLaurin J, Schmitzberger M, Freytes IM, Orozco T, Dang S, Uphold CR. The stroke caregiving trajectory in relation to caregiver depressive symptoms, burden, and intervention outcomes. Top Stroke Rehabil. 2017 Oct;24(7):488-495. doi: 10.1080/10749357.2017.1338371. Epub 2017 Jun 15.
citation: LeLaurin J, Schmitzberger M, Eliazar-Macke N, Freytes IM, Dang S, Uphold C. A commentary on methodological issues in stroke caregiver research: lessons learned from three RESCUE intervention studies. Top Stroke Rehabil. 2019 Jul;26(5):399-404. doi: 10.1080/10749357.2019.1607485. Epub 2019 Apr 30.
citation: LeLaurin JH, Lamba AH, Eliazar-Macke ND, Schmitzberger MK, Freytes IM, Dang S, Vogel WB, Levy CE, Klanchar SA, Beyth RJ, Shorr RI, Uphold CR. Postdischarge Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 11;9(11):e21799. doi: 10.2196/21799.