RESCUE Stroke Caregiver Website to Enhance Discharge Planning

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01600131
First received: May 14, 2012
Last updated: July 16, 2015
Last verified: July 2015
  Purpose

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 13 weeks post-discharge from in-patient settings. 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 13 weeks post-discharge. 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 13 weeks post-discharge. 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 3 study sites (North Florida/South Georgia Veterans Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa) in VISN8. 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 4 weeks and 13 weeks 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.


Condition Intervention Phase
Depression
Quality of Life
Self Efficacy
Recovery of Function
Stress
Positive Aspects of Caregiving
Behavioral: Caregiver problem-solving
Other: Standard Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale.

  • burden [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Measured by the Short Version of the Zarit Burden Interview


Secondary Outcome Measures:
  • Revised Scale for Caregiver Self Efficacy (Steffen et al 2002) [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
  • Positive Aspects of Caregiving [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Measured by Positive Aspects of Caregiving Scale

  • Health-related Quality of Life [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Measured by the Rand 12-item Health Survey (VR-12)

  • Perceived stress [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Measured by the Perceived Stress Scale

  • Stroke Knowledge [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Measured by the Stroke Knowledge Instrument developed by the National Institutes of Health

  • General Patient Satisfaction [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    measured by the General Satisfaction Subscale of the Long-Form Patient Satisfaction Questionnaire

  • Veteran functional status [ Time Frame: 13 weeks post-discharge ] [ Designated as safety issue: No ]
    Measured by the Barthel Index


Estimated Enrollment: 240
Study Start Date: June 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. We will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our previously developed and nationally available RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). We will also provide on-line, skills training and application of the problem-solving approach via the RESCUE messaging center.
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. We will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our previously developed and nationally available RESCUE Caregiver website (www.ciddr8.research.va.gov/rescue). We will also provide on-line, skills training and application of the problem-solving approach via the RESCUE messaging center.
Standard Care
Caregivers receiving standard of care
Other: Standard Care
No intervention or treatment will be provided. We will closely monitor the usual care that is provided to caregivers.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • plan to be ultimately discharged to home
  • are agreeable to be randomized to the intervention or attention 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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600131

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) 376-1611 ext 4971 Ivette.Freytes@va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Constance R Uphold, PhD MS BS    (352) 376-1611 ext 6912    Connie.Uphold@va.gov   
Contact: Ivette M Freytes, PhD MEd BA    (352) 376-1611 ext 4971    Ivette.Freytes@va.gov   
Sub-Investigator: Charles E. Levy, MD BA         
Principal Investigator: Constance R. Uphold, PhD MS BS         
Sub-Investigator: Ivette Magaly Freytes, PhD MEd BA         
Sub-Investigator: Rebecca J. Beyth, MD MSc         
Sub-Investigator: Ronald I. Shorr, MD MS BA         
Sub-Investigator: W. Bruce Vogel, PhD MA BS         
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Stuti Dang    305-575-3388    Stuti.Dang@va.gov   
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Karen Besterman-Dahan    813-558-3952    Karen.Besterman-Dahan@va.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Constance R. Uphold, PhD MS BS North Florida/South Georgia Veterans Health System, Gainesville, FL
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01600131     History of Changes
Other Study ID Numbers: IIR 11-343
Study First Received: May 14, 2012
Last Updated: July 16, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 26, 2015