RESCUE Stroke Caregiver Website to Enhance Discharge Planning

Depression Clinical Trial

— RESCUE  

Official title:

Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600131
• Other study ID #: IIR 11-343
• Status: Completed
• Phase: N/A
• Start date: June 22, 2015
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Positive Aspects of Caregiving
• Quality of Life
• Recovery of Function
• Self Efficacy
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida
United States	Miami VA Healthcare System, Miami, FL	Miami	Florida
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Graf R, LeLaurin J, Schmitzberger M, Freytes IM, Orozco T, Dang S, Uphold CR. The stroke caregiving trajectory in relation to caregiver depressive symptoms, burden, and intervention outcomes. Top Stroke Rehabil. 2017 Oct;24(7):488-495. doi: 10.1080/107493 — View Citation

LeLaurin J, Schmitzberger M, Eliazar-Macke N, Freytes IM, Dang S, Uphold C. A commentary on methodological issues in stroke caregiver research: lessons learned from three RESCUE intervention studies. Top Stroke Rehabil. 2019 Jul;26(5):399-404. doi: 10.108 — View Citation

LeLaurin JH, Lamba AH, Eliazar-Macke ND, Schmitzberger MK, Freytes IM, Dang S, Vogel WB, Levy CE, Klanchar SA, Beyth RJ, Shorr RI, Uphold CR. Postdischarge Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depressive Symptoms at 11 Weeks	Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.	11 weeks after baseline
Primary	Change in Depressive Symptoms at 19 Weeks	Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.	19 weeks after baseline
Primary	Change in Caregiver Burden - Zarit	Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.	11 weeks after baseline
Primary	Change in Caregiver Burden - Zarit	Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.	19 weeks after baseline
Primary	Change in Caregiver Burden - Time Required	Changes in caregiver burden - time required will be measured by the Oberst Caregiving Burden Scale (OCBS). It contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.	11 weeks after baseline
Primary	Change in Caregiver Burden - Time Required	Changes in caregiver burden - time required will be measured by the Oberst Caregiving Burden Scale (OCBS). It contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.	19 weeks after baseline
Primary	Change in Caregiver Burden - Task Difficulty	Changes in caregiver burden - task difficulty will be measured by the Oberst Caregiving Burden Scale (OCBS). The OCBS contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.	11 weeks after baseline
Primary	Change in Caregiver Burden - Task Difficulty	Changes in caregiver burden - task difficulty will be measured by the Oberst Caregiving Burden Scale (OCBS). The OCBS contains 15 items that rate different types of caregiving tasks for stroke survivors based on perceived time and difficulty of the task. Each item is scored on a scale of 1 to 5 (total range from 15 to 75) with higher scores indicating greater time required or higher task difficulty.	19 weeks after baseline
Secondary	Change in Perceived Stress	Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.	11 weeks after baseline
Secondary	Change in Perceived Stress	Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.	19 weeks after baseline
Secondary	Change in Positive Perceptions of Caregiving	Changes in positive perceptions of caregiving will be measured by the Positive Aspects of Caregiving Scale. The scale contains 11 items scored from 1 (disagree a lot) to 5 (agree a lot). Total range from 11 to 55. Higher scores indicate more positive perceptions of caregiving.	11 weeks after baseline
Secondary	Change in Positive Perceptions of Caregiving	Changes in positive perceptions of caregiving will be measured by the Positive Aspects of Caregiving Scale. The scale contains 11 items scored from 1 (disagree a lot) to 5 (agree a lot). Total range from 11 to 55. Higher scores indicate more positive perceptions of caregiving.	19 weeks after baseline
Secondary	Change in Stroke Knowledge	Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge.	11 weeks after baseline
Secondary	Change in Stroke Knowledge	Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge.	19 weeks after baseline
Secondary	Change in General Patient Satisfaction	Changes in patient satisfaction will be measured by the General Satisfaction Subscale of the Long-Form Patient Satisfaction Questionnaire. This 6-item measure is scored from 1 (strongly agree) to 5 (strongly disagree). Total range from 6 to 30. Higher scores reflect better satisfaction with healthcare.	11 weeks after baseline
Secondary	Change in General Patient Satisfaction	Changes in patient satisfaction will be measured by the General Satisfaction Subscale of the Long-Form Patient Satisfaction Questionnaire. This 6-item measure is scored from 1 (strongly agree) to 5 (strongly disagree). Total range from 6 to 30. Higher scores reflect better satisfaction with healthcare.	19 weeks after baseline
Secondary	Change in Veteran Functional Status	Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities.	11 weeks after baseline
Secondary	Change in Veteran Functional Status	Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities.	19 weeks after baseline
Secondary	Change in Self-efficacy - Obtaining Respite	Measured by Revised Scale for Caregiver Self Efficacy - Obtaining Respite subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.	11 weeks after baseline
Secondary	Change in Self-efficacy - Obtaining Respite	Measured by Revised Scale for Caregiver Self Efficacy - Obtaining Respite subscale (Steffen et al 2002). The subscale measures caregivers' confidence to ask for assistance. The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) that they could perform the activity. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.	19 weeks after baseline
Secondary	Change in Self-efficacy - Controlling Upsetting Thoughts	Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.	11 weeks after baseline
Secondary	Change in Self-efficacy - Controlling Upsetting Thoughts	Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.	19 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Physical	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.	11 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Physical	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.	19 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Mental Health	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.	11 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Mental Health	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.	19 weeks after baseline