RESCUE Stroke Caregiver Website to Enhance Discharge Planning (RESCUE)

• ClinicalTrials.gov Identifier: NCT01600131
• Recruitment Status: Recruiting
• First Posted: May 16, 2012
• Last Update Posted: September 4, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: May 14, 2012
• First Posted Date: May 16, 2012
• Last Update Posted Date: September 4, 2020
• Actual Study Start Date: June 22, 2015
• Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2016)

• Depressive symptoms [ Time Frame: 11 and 19 weeks after baseline ]
  Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale.
• Burden [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by the Short Version of the Zarit Burden Interview

Original Primary Outcome Measures (submitted: May 15, 2012)

Depressive symptoms [ Time Frame: 14 weeks post-discharge ]

Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale.

Current Secondary Outcome Measures (submitted: June 28, 2017)

• Self-Efficacy [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by Revised Scale for Caregiver Self Efficacy (Steffen et al 2002)
• Positive Aspects of Caregiving [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by Positive Aspects of Caregiving Scale
• Health-related Quality of Life [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by the Rand 12-item Health Survey (VR-12)
• Perceived stress [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by the Perceived Stress Scale
• Stroke Knowledge [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by the Stroke Knowledge Instrument developed by the National Institutes of Health
• General Patient Satisfaction [ Time Frame: 11 and 19 weeks after baseline ]
  measured by the General Satisfaction Subscale of the Long-Form Patient Satisfaction Questionnaire
• Veteran functional status [ Time Frame: 11 and 19 weeks after baseline ]
  Measured by the Barthel Index

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RESCUE Stroke Caregiver Website to Enhance Discharge Planning
• Official Title: Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Depression
• Quality of Life
• Self Efficacy
• Recovery of Function
• Stress
• Positive Aspects of Caregiving

Intervention

• Behavioral: Caregiver problem-solving
  This is a problem-solving intervention for stroke caregivers that can be delivered shortly after the Veteran's 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 the investigators' previously developed and nationally available RESCUE Caregiver website (www.ciddr8.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.
• Other: Standard Care
  No intervention or treatment will be provided. The investigators will closely monitor the usual care that is provided to caregivers.

Study Arms

• Experimental: Caregiver education and support
  problem-solving intervention for stroke caregivers that can be delivered shortly after the Veteran's 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 the investigators' 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.
  Intervention: Behavioral: Caregiver problem-solving
• Standard Care
  Caregivers receiving standard of care
  Intervention: Other: Standard Care

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 15, 2012): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2021
• Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Constance R Uphold, PhD MS BS; (352) 376-1611 ext 6912; Connie.Uphold@va.gov

Contact: Ivette M Freytes, PhD MEd BA; (352) 264-3836 ext 201240; Ivette.Freytes@va.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01600131
• Other Study ID Numbers: IIR 11-343
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: VA Office of Research and Development
• Study Sponsor: VA Office of Research and Development
• Collaborators: Not Provided

Investigators

• Principal Investigator: Constance R. Uphold, PhD MS BS; North Florida/South Georgia Veterans Health System, Gainesville, FL

• PRS Account: VA Office of Research and Development
• Verification Date: September 2020