RESCUE Stroke Caregiver Website to Enhance Discharge Planning (RESCUE)
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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 |
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Recruitment Status :
Recruiting
First Posted : May 16, 2012
Last Update Posted : September 4, 2020
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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 : | March 1, 2021 |
| Estimated Study Completion Date : | March 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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Standard Care
Caregivers receiving standard of care
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Other: Standard Care
No intervention or treatment will be provided. The investigators will closely monitor the usual care that is provided to caregivers. |
- 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
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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).
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
| 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 |
| 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 | |
| Principal Investigator: | Constance R. Uphold, PhD MS BS | North Florida/South Georgia Veterans Health System, Gainesville, FL |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT01600131 |
| Other Study ID Numbers: |
IIR 11-343 |
| First Posted: | May 16, 2012 Key Record Dates |
| Last Update Posted: | September 4, 2020 |
| Last Verified: | September 2020 |
| 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 |