跳至主要内容
临床试验/NCT04001699
NCT04001699已完成不适用

Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity - a Randomized Clinical Trial

University of Eastern Finland2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2019年8月19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
入组人数
157
试验地点
2
主要终点
Health-related quality of life (15-D)

研究概览

简要总结

The objective of this randomized control trial is to investigate effects and cost effectiveness of interprofessional preoperative assessment among older knee or hip arthroplasty patients. The main hypothesis is that preoperative assessment and optimization have a positive impact on the patents' quality of life and expenditure of social and health care services.

详细描述

Knee and hip arthrosis are common conditions among older adults. Progression of arthrosis often leads to worsening of symptoms and decreased mobility, daily functioning and quality of life. Total joint arthroplasty improves pain in end-stage arthrosis but accustomed postoperative care and rehabilitation alone may not guarantee optimal regain of functioning for frail and vulnerable older arthroplasty patients. Preoperative optimization of older patients with multimorbidity and functional limitations may improve benefits of the arthroplasty even at lower costs. Patients randomized into intervention arm of the present study receive preoperative assessment with treatment and prehabilitation plan. The focuses of the intervention are patient's chronic conditions, nutritional status, medication and physical activity. The intervention is delivered by multiprofessional team (geriatrician, registered nurse, physiotherapist and pharmacist).

Older adults undergoing surgery are a rapidly growing but vulnerable patient group. Knowledge on effects of preoperative evaluation and optimization is sparse, especially on the effects of multi-domain interventions.

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

入选标准

  • Place of residence: Kuopio or Vesanto municipality
  • Age ≥ 65 years
  • Clinical decision for knee or hip arthroplasty, elective operation with more than one month waiting time, primary arthroplasty of the index joint.
  • Multimorbidity: the patient has at least two chronic diseases with potential to affect functioning, diseases are defined according to the Function Comorbidity Index (FCI)
  • Additional inclusion criteria, at least two of the following:
  • 5 or more medicines taken regularly (polypharmacy)
  • continuous walking distance less than 500 m
  • needs help in dressing and/or washing oneself
  • needs help when visiting or taking care of businesses outside home
  • body mass index ≤ 23 or ≥ 34

排除标准

  • - does not meet the above inclusion criteria

研究组 & 干预措施

Usual care

Active Comparator

Usual care

干预措施: Preoperative geriatric assessment (Other)

Intervention

Experimental

Preoperative assessment conducted by an interprofessional team

干预措施: Preoperative geriatric assessment (Other)

结局指标

主要结局

Health-related quality of life (15-D)

时间窗: Preoperative measurement at baseline, postoperative measurements 3 and 9 months after the arthroplasty.

Change in quality of life is measured using the 15-dimensions health-related quality of life questionnaire (15-D) in three time points

Costs of social and health care services

时间窗: Changes in costs of care are evaluated for a period starting from one year before and ending two years after the baseline examinations.

Data on the use and costs of social and health care services are obtained from the national and local care registers. The costs of the intervention are evaluated by measuring working time of the inter-professional team members (used per every study patient).

次要结局

未报告次要终点

研究者

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

Eija Lönnroos

professor

University of Eastern Finland

研究点 (2)

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