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临床试验/NCT04995848
NCT04995848招募中不适用

Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende

Aalborg University1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2021年5月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
182
试验地点
1
主要终点
Changes in Quality of life

研究概览

简要总结

This project has focus on patients in palliation testing a digital platform TelePal.dk.

详细描述

The aim of the RCT study is to:

• Test, implement, and evaluate a telepalliation program for patients receiving palliative care (cancer, heart failure (HF), COPD, and motor neuron disease) from a clinical, psychosocial, inter-organizational, and health economic perspective.

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

  • •Over 18 years
  • •Live in Esbjerg, Varde, Billund, Fanø or Vejen Municipality
  • •Cancer, heart failure, chronic obstructive pulmonary disease (COPD), and motor neuron disease (neurological diseases) referred to the Palliation Team at Southwest Jutland Hospital
  • •Basic computer skills or a relative who has basic computer skills

排除标准

  • •Delirium at enrolment based on CAM score
  • •Active psychiatric history (as noted in the medical record) other than depression or anxiety related to the main diagnosis referred to palliative care
  • •Lack of ability to cooperate

研究组 & 干预措施

Telepalliation group

Experimental

The intervention group will participate in the telepalliation program. The patients will lent a tablet during the RCT study to access the TelePal.dk platform an video consultations. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until:

  1. They stop being followed by the Palliative Team due to lack of symptoms
  2. They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either:
  • The project nurse or the clinical responsible doctor at the patients' home OR
  • A district nurse under video supervision by the project nurse or the clinical responsible doctor
  1. Death of the patient

干预措施: Telepalliation (Other)

Conventional palliation program

No Intervention

The control group will follow a conventional palliation program. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until:

  1. They stop being followed by the Palliative Team due to lack of symptoms
  2. They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either:
  • The project nurse or the clinical responsible doctor at the patients' home OR
  • A district nurse under video supervision by the project nurse or the clinical responsible doctor
  1. Death of the patient

结局指标

主要结局

Changes in Quality of life

时间窗: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26

Measured by the European Organization for Research and Treatment of Cancer, questionnaire regarding quality of life in palliative cancer care patients (EORTC QLQ-C15-PAL).

次要结局

  • Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals(12 months)
  • Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals(12 months)
  • Experience of pain (brief)(At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program(Week 4)
  • Experiences of health care professionals on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program(6 months and 12 months)
  • Health related quality of life(week 1 and week 4)
  • Cost of healthcare services(24 months)
  • Changes in feeling of security(At baseline, twice every week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Experiences of pain(At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Changes in medicine(At enrolment and week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26)
  • Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program(Week 4 and 3 months)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Birthe Dinesen

Professor

Aalborg University

研究点 (1)

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