跳至主要内容
临床试验/NCT01721239
NCT01721239已完成不适用

Recovery and Aftercare in Post Intensive Care Therapy Patients - The RAPIT Study. The Effectiveness and Experiences of a Follow-up Program for Danish Mechanically Ventilated ICU Patients: A Pragmatic Randomized Controlled Multicentre Trial.

Hillerod Hospital, Denmark2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
340
试验地点
2
主要终点
Quality of Life

研究概览

简要总结

In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up).

During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU.

The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.

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
Single (Outcomes Assessor)

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

  • Age ≥ 18 years
  • Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines).
  • APACHE II score ≥ 12 ≤ 29
  • Unrecognized dementia diagnosis

排除标准

  • Delirium at randomization (Positive CAM-ICU score)
  • Participation in scientific projects which include patient interviews
  • Not Speak and understand Danish

研究组 & 干预措施

Control group

No Intervention

No intervention

Standardized Followup program

Experimental

Standardized written information, patient photos and three follow-up consultations.

干预措施: Standardized Followup program (Other)

结局指标

主要结局

Quality of Life

时间窗: 12 months

Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to quality of life, on the mental component of the instrument, SF-36 Intension-to-treat analysis

次要结局

  • Symptom Scores(12 months)
  • Baseline data(At randomization)
  • Sense of Coherence(12 months)
  • Symptom score(12 months)
  • Depression(12 months)

研究者

发起方
Hillerod Hospital, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Janet Froulund Jensen

PHD, MSc Health Science, RN.

Hillerod Hospital, Denmark

研究点 (2)

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