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临床试验/NCT03157973
NCT03157973已完成不适用

Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年12月1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
120
试验地点
2
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

This study evaluates the effects of an eHealth tool and psychosocial support on anxiety, depression and health-related quality of life in patients undergoing surgical treatment for abdominal aortic aneurysm (AAA). Participants in the intervention group will receive access to the eHealth tool and structured follow-up with a contact nurse, the control group will receive standard of care.

详细描述

Abdominal aortic anuerysm (AAA) is associated with a decreased health-related quality of life (HRQoL) both at diagnosis and during surgical treatment, although recent studies report somewhat contradictory results. In qualitative research, it has been shown that the health care system fails to meet the patients' information need, as well as their need for psychosocial support during the care process. The aim of this study is therefore to evaluate the effects of an intervention comprising an eHealth tool with individualized information in combination with structured follow-up with a contact nurse on anxiety, depression and HRQoL in patients undergoing surgical treatment for AAA.

Patients who are planned for elective surgical treatment, fulfil the inclusion criteria and none of the exclusion criteria will fill out questionnaires. The control group will receive information and follow-up per institution's standard of care. The intervention group will be given access to the eHealth tool, containing individualized information about the condition, surgical procedure and self-care. They will also receive structured follow-up by a contact nurse at discharge, 3 and 12 months postoperatively.

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

盲法说明

The nature of the intervention rules out masking.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to speak and understand Swedish
  • Planned for elective surgical repair of an abdominal aortic aneurysm

排除标准

  • Severe visual impairment or blindness
  • Severe hearing impairment or deafness
  • Diagnosed dementia
  • Medical condition with a suspected life expectancy of < 1 year.

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: 12 months

A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.

次要结局

  • SF12(12 months)
  • Quality from the patient's perspective (QPP)(12 months)

研究者

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

Olga Nilsson

RN, SC

Karolinska University Hospital

研究点 (2)

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