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Trial record 2 of 4874 for:    RESCUE

RESCUE Stroke Caregiver Website to Enhance Discharge Planning (RESCUE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01600131
Recruitment Status : Recruiting
First Posted : May 16, 2012
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 14, 2012
First Posted Date  ICMJE May 16, 2012
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE June 22, 2015
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RESCUE Stroke Caregiver Website to Enhance Discharge Planning
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Depression
  • Quality of Life
  • Self Efficacy
  • Recovery of Function
  • Stress
  • Positive Aspects of Caregiving
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2012)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01600131
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP