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RESCUE Stroke Caregiver Website to Enhance Discharge Planning (RESCUE)

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ClinicalTrials.gov Identifier: NCT01600131
Recruitment Status : Recruiting
First Posted : May 16, 2012
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Depression Quality of Life Self Efficacy Recovery of Function Stress Positive Aspects of Caregiving Behavioral: Caregiver problem-solving Other: Standard Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning
Actual Study Start Date : June 22, 2015
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
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.
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.

Standard Care
Caregivers receiving standard of care
Other: Standard Care
No intervention or treatment will be provided. The investigators will closely monitor the usual care that is provided to caregivers.




Primary Outcome Measures :
  1. 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.

  2. Burden [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by the Short Version of the Zarit Burden Interview


Secondary Outcome Measures :
  1. Self-Efficacy [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by Revised Scale for Caregiver Self Efficacy (Steffen et al 2002)

  2. Positive Aspects of Caregiving [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by Positive Aspects of Caregiving Scale

  3. Health-related Quality of Life [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by the Rand 12-item Health Survey (VR-12)

  4. Perceived stress [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by the Perceived Stress Scale

  5. Stroke Knowledge [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by the Stroke Knowledge Instrument developed by the National Institutes of Health

  6. General Patient Satisfaction [ Time Frame: 11 and 19 weeks after baseline ]
    measured by the General Satisfaction Subscale of the Long-Form Patient Satisfaction Questionnaire

  7. Veteran functional status [ Time Frame: 11 and 19 weeks after baseline ]
    Measured by the Barthel Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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) 264-3836 ext 201240 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) 264-3836 ext 201240    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: Sergio Romero, PhD MS BS         
Sub-Investigator: Walter Bruce Vogel, PhD MA BS         
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Stuti Dang, MD MPH    305-575-3388 ext 6679    stuti.dang@va.gov   
Sub-Investigator: Stuti Dang, MD MPH         
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Karen Besterman-Dahan, PhD MA BS    813-558-3952    Karen.Besterman-Dahan@va.gov   
Sub-Investigator: Karen Besterman-Dahan, PhD MA BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Constance R. Uphold, PhD MS BS North Florida/South Georgia Veterans Health System, Gainesville, FL

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01600131     History of Changes
Other Study ID Numbers: IIR 11-343
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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