RESCUE Stroke Caregiver Website to Enhance Discharge Planning

NCT01600131 | Completed Results DMC

• 1 other identifier: IIR 11-343
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Change in Depressive Symptoms at 11 Weeks

  Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.

  11 weeks after baseline

• Change in Depressive Symptoms at 19 Weeks

  Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.

  19 weeks after baseline

• Change in Caregiver Burden - Zarit

  Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.

  11 weeks after baseline

• Change in Caregiver Burden - Zarit

  Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.

  19 weeks after baseline

• Change in Caregiver Burden - Time Required

  Changes in caregiver burden - time required will be measured by the Oberst Caregiving Burden Scale (OCBS). It contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

  11 weeks after baseline

• Change in Caregiver Burden - Time Required

  Changes in caregiver burden - time required will be measured by the Oberst Caregiving Burden Scale (OCBS). It contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

  19 weeks after baseline

• Change in Caregiver Burden - Task Difficulty

  Changes in caregiver burden - task difficulty will be measured by the Oberst Caregiving Burden Scale (OCBS). The OCBS contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

  11 weeks after baseline

• Change in Caregiver Burden - Task Difficulty

  Changes in caregiver burden - task difficulty will be measured by the Oberst Caregiving Burden Scale (OCBS). The OCBS contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.

  19 weeks after baseline

Secondary Outcomes (18)

• Change in Perceived Stress

  11 weeks after baseline

• Change in Perceived Stress

  19 weeks after baseline

• Change in Positive Perceptions of Caregiving

  11 weeks after baseline

• Change in Positive Perceptions of Caregiving

  19 weeks after baseline

• Change in Stroke Knowledge

  11 weeks after baseline

Study Arms (2)

Caregiver education and support

EXPERIMENTAL

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.

Behavioral: Caregiver problem-solving

Standard Care

OTHER

Caregivers receiving standard of care

Other: Standard Care

Interventions

Caregiver problem-solving BEHAVIORAL

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.

Caregiver education and support

Standard Care OTHER

No intervention or treatment will be provided. The investigators will closely monitor the usual care that is provided to caregivers.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (3)

• 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.

  PMID: 28618848 RESULT

• 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.

  PMID: 31038012 RESULT

• 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.

  PMID: 33174856 RESULT

MeSH Terms

Conditions

Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The intervention effects must be interpreted with caution. The study had reduced statistical power, which may have reduced the chances of detecting true effects of the intervention on some of the outcomes. Based on our original power analysis, we planned for a sample size of 240, but enrolled only 174 caregivers. Also, the effect size of the intervention may be overestimated as the intervention group had a higher attrition rate than the usual care group.

Results Point of Contact

• Title: Constance Uphold
• Organization: Veterans Health Administration

connie.uphold@va.gov

352-548-6000

Study Officials

• Constance R. Uphold, PhD MS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: June 22, 2015
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: January 17, 2023
• Results First Posted: January 17, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)