跳至主要内容
临床试验/NCT03712410
NCT03712410已完成不适用

A Problem Solving Intervention for Hospice Caregivers

George Demiris, PhD2 个研究点 分布在 1 个国家目标入组 523 人开始时间: 2018年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
523
试验地点
2
主要终点
Table 3. Comparison of Traditional PISCES vs. Online PISCES

研究概览

简要总结

Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.

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

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)
  • speak and read English, with at least a 6th-grade education

排除标准

  • hearing or visual impairment that prohibits from conducting phone conversations or video conference sessions

结局指标

主要结局

Table 3. Comparison of Traditional PISCES vs. Online PISCES

时间窗: from baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30)

Comparison of Traditional PISCES vs. Online PISCES Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

Table 2. Comparison of 4 Groups

时间窗: from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)

Comparison of 4 groups Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress) Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life)

Table 4. Within-Group Comparison Baseline vs. Follow-up

时间窗: from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)

Within-Group Comparison Baseline vs. Follow-up Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

次要结局

未报告次要终点

研究者

发起方
George Demiris, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

George Demiris, PhD

PIK Professor

University of Pennsylvania

研究点 (2)

Loading locations...

相似试验