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临床试验/NCT03628469
NCT03628469已完成不适用

Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support

Frederiksberg University Hospital1 个研究点 分布在 1 个国家目标入组 5,454 人开始时间: 2018年4月9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
5,454
试验地点
1
主要终点
Hospital admissions

研究概览

简要总结

Proactive Health Support is a randomized controlled trial of telephone-based self-management support. The primary aim of the intervention is to reduce hospital admissions and improve quality of life in patients with a high risk of hospital admission.

详细描述

Participants are identified through an algorithm, that assigns each patient with a risk score of 0-100%. Patients with the highest risk in each of the five regions of Denmark are invited to participate.

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

入选标准

  • Persons with a hospital contact within the last year caused by ≥ 1 of the following diagnoses: heart diseases (DI110, DI130, DI132, DI50), connective tissue diseases (DD86, DM05, DM06, DM08, DM09, DM30, DM31, DM32, DM33, DM34, DM35, DM36), pulmonary diseases (DJ40, DJ41, DJ42, DJ43, DJ44, DJ45, DJ46, DJ47, DJ60, DJ61, , DJ62, DJ63, DJ64, DJ65, DJ66, DJ67, DJ684, DJ701, DJ703, DJ841, DJ842, DJ843, DJ848, DJ849, DJ920, DJ961, DJ982, DJ983) or diabetes (DE10, DE11, DE14) Or
  • Persons ≥ 18 years and ≥ three unplanned hospital admissions in the last six months Or
  • Persons ≥ 65 years with a preventable hospital admission (predefined diagnoses: dehydration, constipation, lower respiratory tract infections, urinary tract infections, gastroenteritis, fractures, nutrition deficiency anemia, social causes and pressure ulcers) or a readmission (within 30 days)

排除标准

  • Selected psychiatric diagnoses: substance abuse disorder (DF1), schizophrenia (DF2) or dementia (DF00, DF01, DF02, DF03, DF051)
  • Metastatic cancer (DC77, DC78, DC79, DC80)
  • Assisted living Facility
  • Documented terminal illness or life expectancy < one year
  • Assessment of dementia
  • Major surgery planned within 6 months
  • Hearing impairment
  • Not speaking Danish
  • Cognitive impairment
  • Substance abuse, that impairs adherence
  • No telephone
  • Receiving similar trial intervention
  • Other (including intervention not suitable)

结局指标

主要结局

Hospital admissions

时间窗: 6 months

Quality of life

时间窗: 6 months

Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)

次要结局

  • Survival(1 year)
  • Patient education(3, 6 and 12 months)
  • Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years(3, 6 and 12 months)
  • Regional differences in resource use and costs(3, 6 and 12 months)
  • Outpatient consultations(3, 6 and 12 months)
  • Use of primary healthcare(3, 6 and 12 months)
  • Use of prescription medication(3, 6 and 12 months)
  • Resource use in primary care and rehabilitation(3, 6 and 12 months)
  • Quality of life(3, 6 and 12 months)

研究者

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

Ulla Toft

Senior Researcher, Principal Investigator

Frederiksberg University Hospital

研究点 (1)

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