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临床试验/NCT03339271
NCT03339271已完成不适用

Technology-enhanced Transitional Palliative Care for Family Caregivers in Rural Settings

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2018年3月20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
Mayo Clinic
入组人数
384
试验地点
2
主要终点
Change in Preparedness for Caregiving Scale Score

研究概览

简要总结

The purpose of this study is to evaluate the effect and cost of technology-enhanced transitional palliative care on family caregivers who provide care to a loved one after a hospitalization.

详细描述

There will be two groups in this randomized control study: technology-enhanced group and usual care group. The total amount of subjects includes both the palliative care recipients and the family caregivers (both the patients and their family caregiver will sign informed consent.)

A family caregiver is broadly defined as the person self-identified as the family member or unpaid friend who is the primary informal caregiver for a patient with a terminal illness. The family caregiver may or may not be a member of the patient's nuclear family.

For the technology-enhanced group, the study nurse experienced in palliative care will have a visit with the caregiver within the first 24 hours after consent, and have daily visits with the caregiver as long as the patient is still in the hospital. During these visits, the nurse will talk to the caregiver about their own self-care needs, begin transitional care planning, and develop Readiness Plans to anticipate care giving needs the caregiver may have when they discharge from the hospital.

For the technology-enhanced group, the caregiver will take an iPad home so that the study team nurse can video chat with them. The iPad will need to be returned upon completion of the study. The study nurse will have a video chat with the caregiver at home within 24-48 hours of discharge from the hospital, and at least weekly for 8 weeks after that. The caregiver and the study nurse may also decide to have other calls on the phone during this time.

For the usual care group, doctors and nurses along with input from the Palliative Care service will help the caregiver make a plan for discharge from the hospital and for taking care of the patient upon discharge. Someone from the study team will call the caregiver once a month to check in for the 6 months after the patient discharges from the hospital.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult family caregiver of adult patient hospitalized at Mayo Clinic
  • Receives in-hospital palliative care consult
  • Family caregiver lives in a Minnesota or Iowa county that is designated as medically under served or rural area

排除标准

  • Family caregivers who live in Rochester, Minnesota. (Rochester, Minnesota is not considered a medically under served or rural area.)
  • Patients with left ventricular assistive devices, documented chronic pain, use of home infusion pain pumps, or documented addictive behaviors.

结局指标

主要结局

Change in Preparedness for Caregiving Scale Score

时间窗: Baseline, 8 weeks

The Preparedness for Caregiving Scale captures how well family caregivers feel they are prepared for the multiple aspects of the caregiving role, using a 4-point response set ranging from 0 ("not at all") to 4 ("very well"). A mean score is calculated; higher scores indicate greater preparation for caregiving.

次要结局

  • Mean Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score(baseline, 8 weeks)
  • Mean Total Out-of-Pocket Expenditures at 6 Months(6 months)
  • Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score(baseline, 8 weeks)
  • Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score(baseline, 8 weeks)
  • Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score(baseline, 8 weeks)
  • Post Discharge Coping Difficulty Scale (PDCDS) Score(2 weeks)
  • Change in Communication With Physicians Scale Score(baseline, 8 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joan M. Griffin

Principal Investigator

Mayo Clinic

研究点 (2)

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