Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 8
- 主要终点
- Change in Caregiver Depression at 9 Weeks
研究概览
简要总结
This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.
详细描述
This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.
The investigators will conduct a two-arm (8-session intervention vs. standard care), , randomized controlled trial to test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. A sample of 290 stroke caregivers will be randomly assigned to either an intervention or a standard care group. Eligibility criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group. We will determine caregiver status.
Baseline measurements will be conducted with the caregivers prior to the intervention. Post-test assessments will be collected at 1 and 12 weeks post-intervention. In addition, the investigators will obtain pre- and post-test measures of Veteran-related variables via Computerized Patient Record System (CPRS) electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention. A general linear mixed model for repeated measures will be used to examine the relationship between treatment assignment and each outcome over time. The investigators will measure the budgetary impact of providing intervention by comparing the costs of the intervention group to the costs of the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI and data collectors will be blinded in this study.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group.
- •Random assignment to the intervention or standard care group. The investigators will determine caregiver status.
排除标准
- •The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria or are managing end-of-life issues (stroke survivors are likely to die within five months following discharge).
结局指标
主要结局
Change in Caregiver Depression at 9 Weeks
时间窗: 9 weeks after baseline
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
Change in Caregiver Depression at 21 Weeks
时间窗: 21 weeks after baseline
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
次要结局
- Change in Caregiver Burden-Zarit - 9 Weeks(9 weeks)
- Change in Caregiver Burden-Zarit - 21 Weeks(21 weeks)
- Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks(9 weeks)
- Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks(21 weeks)
- Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks(9 weeks)
- Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks(21 weeks)
- Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks(9 weeks)
- Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks(21 weeks)
- Change in Veteran's Functional Abilities- 9 Weeks(9 weeks)
- Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks(9 weeks)
- Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks(21 weeks)
- Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks(21 weeks)
- Change in Veteran's Functional Abilities- 21 Weeks(21 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks(9 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks(9 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks(9 weeks)
- Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks(9 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks(21 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks(21 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks(21 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks(21 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks(9 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks(9 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks(21 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks(9 weeks)
- Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks(21 weeks)