A Problem Solving Intervention for Hospice Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 2
- 主要终点
- Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
研究概览
简要总结
In recent years, the demand for home hospice care has grown rapidly. Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves. It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking. In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence. The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness. This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2). The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.
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
- 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
- •enrolled as a family/informal caregiver of a hospice patient
- •18 years or older
- •with access to a standard phone line or Internet and computer access at home
- •without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
- •no or only mild cognitive impairment
- •speak and read English, with at least a 6th-grade education
排除标准
- •lack of phone or Internet access
研究组 & 干预措施
Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
干预措施: Problem Solving Therapy (Behavioral)
Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
干预措施: Problem Solving Therapy (Behavioral)
结局指标
主要结局
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
时间窗: At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
时间窗: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
时间窗: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.
Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
时间窗: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.
Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
时间窗: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.
次要结局
未报告次要终点
研究者
George Demiris
Professor, Biobehavioral Nursing and Health Systems
University of Washington