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临床试验/NCT04437563
NCT04437563Unknown不适用

Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System

Bispebjerg Hospital9 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
9
主要终点
Quality of information from and communication with health care professionals

研究概览

简要总结

The HERMES intervention was developed in a Danish setting after a comprehensive investigation on caregivers' needs. The intervention consists of: 1) a systematic identification of the caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital showed positive results. It reduced the unmet information needs and improved the caregivers' evaluation of the information from and communication with the health care professionals and the perception of being seen and acknowledged as a caregiver. However, although research projects may show a positive effect, this does not mean that the intervention will be easily implemented in the health care system. Nor does it guarantee that the intervention will show the expected results once implemented in a busy clinical routine.

Therefore, the present project will adapt the HERMES intervention to be implemented in Danish departments of oncology and haematology by (in the first part of the project):

  1. Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
  2. Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
  3. Developing a technological solution (an app) for the HERMES intervention in which the responses given by the caregivers will form the basis for a subsequent consultation with the health care staff.
  4. Revising the HERMES intervention based on the outcomes of a-c.
  5. Testing the revised HERMES intervention in a pilot study.

In the second part of the project, the revised HERMES intervention will be tested in a large scale trial with the purpose to:

  1. Implement the revised HERMES intervention in the departments of oncology/haematology.
  2. Test the effect of the revised HERMES intervention.
  3. Evaluate the feasibility of the revised HERMES intervention in a large scale.
  4. Elucidate the effectiveness and the feasibility of the intervention and assess possibilities and potential needs for further adaptation in order to secure the future applicability in the Danish Health Care System.

Thus, the overall aim is that by the end of the study, an evidence based and practical implementable method to (continous) use of the HERMES intervention in the Danish health care system is available.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Adult (18+ years)
  • Primary caregiver (defined as the lay person (partner, family member, friend, etc) most involved in the patient's disease course. The primary caregiver is appointed by the patient)
  • Caregiver of an adult cancer patient starting up a treatment course in an oncological department
  • Written informed consent to participation

排除标准

  • Caregivers not able to read and understand Danish
  • Caregivers with no or minimal contact to the oncological department

结局指标

主要结局

Quality of information from and communication with health care professionals

时间窗: Change from baseline (enrollment) to 3 months follow-up

Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.

次要结局

  • Quality of information from and communication with health care professionals(Change from baseline (enrollment) to 6 months follow-up)
  • Attention from health care professionals(Change from baseline (enrollment) to 6 months follow-up)
  • Positive emotional functioning(Change from baseline (enrollment) to 6 months follow-up)
  • Amount of information from health care professionals(Change from baseline (enrollment) to 6 months follow-up)
  • Caregiver involvement(Change from baseline (enrollment) to 6 months follow-up)
  • Emotional functioning(Change from baseline (enrollment) to 6 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mogens Groenvold

Professor

Bispebjerg Hospital

研究点 (9)

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