Integrating Caregiver Support Into MS Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Patient MS Problems
研究概览
简要总结
With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of caregiver assistance, with a concomitant increase in burden for the caregiver. In fact, effect on caregiver burden can be seen as a potential indicator of the efficacy of MS management, suggesting that the caregiver is an appropriate and independent target for MS therapeutic strategies.
MS patients report difficulty implementing and continuing with home exercise, mobility, and walking programs. This feasibility study will test integration of a successful behavioral caregiving intervention into clinical practice to improve functioning of Veterans with multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a behavioral caregiver intervention designed to address caregiver coping and management of patient concerns, with special focus on patient mobility and walking. A pre-post intervention design will compare outcomes for Veterans and Caregivers.
For Veterans, the intervention will target Caregiver participation in home-based Veteran mobility activities. MS Caregivers report high burden, stress, and depression involved in caring for their loved ones, especially as mobility declines and these outcomes are related to physical and emotional health status of the patient. For Caregivers, the intervention will focus on improving Caregiver coping and on managing MS-related problems. Outcomes for both will be measured at baseline, 3 months, and 6 months.
Study Objectives include:
- Test whether a caregiver intervention can be integrated into an MS clinical setting.
- Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and number of Veteran MS problems and safety alerts reported).
- Determine whether Veteran outcomes are improved (Expanded Disability Status Scale, timed up and go test, self-efficacy, and depression).
- Determine which types of Caregivers will benefit most.
- Determine which types of Veterans will benefit most.
- Refine materials for future clinical research, translation and implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran being seen in MS clinic at Memphis VA
- •Veteran ambulatory
- •Caregiver/care partner who agrees to participate
排除标准
- 未提供
研究组 & 干预措施
Intervention
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
干预措施: Behavioral (Behavioral)
结局指标
主要结局
Number of Patient MS Problems
时间窗: baseline, 6 months
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
时间窗: baseline, 6 months
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Burden Measured With the Zarit Burden Inventory
时间窗: baseline, 6 months
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
时间窗: baseline, 6 months
Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
Bother With Patient MS Problems
时间窗: Baseline, 6 months
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
次要结局
未报告次要终点