RESCUE Stroke Caregiver Website to Enhance Discharge Planning
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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.rorc.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 14 weeks post-discharge from in-patient settings. Aim #2 is to test the effect of the intervention on stroke caregivers' burden, problem-solving abilities, self-efficacy, health-related quality of life (HRQOL), and satisfaction with care at 14 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 14 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 research assistant (RA) will telephone caregivers at 7 weeks and 14 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 discharge-planning intervention combined with technology to improve the quality of caregiving and the recovery of Veterans.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Quality of Life Self Efficacy Problem Solving Recovery of Function |
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 |
- Depressive symptoms [ Time Frame: 14 weeks post-discharge ] [ Designated as safety issue: No ]Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale.
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2016 (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 during the Veterans� 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.rorc.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 during the Veterans' 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.rorc.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 |
Inclusion Criteria:
All caregivers of Veterans with a primary diagnosis of stroke discharged to home from a VA inpatient facility 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 two activity of daily living (ADL) deficits,
- are the significant other or related by blood or marriage to the stroke survivor,
- have Internet access and ability,
- are reachable by cell or home phone,
- read English at the sixth grade reading level or better,
- have low or intermediate levels of social support, and
- agree to random assignment to the intervention or attention control group.
Exclusion Criteria:
Caregivers who fail to meet one or more of the inclusion criteria and whose Veterans
- have a life expectancy of less than 6 months, or
- are enrolled in home-based primary care or a telehealth program.
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| 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 |
| United States, Florida | |
| North Florida/South Georgia Veterans Health System | Not yet 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 | Not yet recruiting |
| Miami, Florida, United States, 33125 | |
| Contact: Stuti Dang 305-575-3388 Stuti.Dang@va.gov | |
| James A. Haley Veterans' Hospital, Tampa, FL | Not yet recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Christine A Elnitsky 813-558-3986 Christine.Elnitsky@va.gov | |
| Principal Investigator: | Constance R. Uphold, PhD MS BS | North Florida/South Georgia Veterans Health System |
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: | March 20, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013