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临床试验/NCT02673580
NCT02673580已完成不适用

Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up

University of Aarhus2 个研究点 分布在 1 个国家目标入组 593 人开始时间: 2016年1月最近更新:
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
593
试验地点
2
主要终点
Number of contacts

研究概览

简要总结

The aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up)

详细描述

The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Males and females from Age 15 years
  • Diagnosis of epilepsy
  • Referred to standard telePRO by a clinician
  • Access to internet (web-responders in standard telePRO)
  • Can speak and understand Danish

排除标准

  • Paper responders
  • Referred to telePRO proxy questionnaire

研究组 & 干预措施

Open Access telePRO

Other

Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.

干预措施: Open Access telePRO (Other)

Standard telePRO

Other

No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.

干预措施: Standard telePRO (Other)

结局指标

主要结局

Number of contacts

时间窗: 18 months

Number of contacts includes all contacts with the outpatient clinic in the study follow-up period

次要结局

  • Mortality(18 months)
  • Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)(18 months)
  • Self-efficacy will be assessed by The General Self-Efficacy Scale(18 months)
  • Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(18 months)
  • General health will be assessed by items from the SF-36 questionnaire(18 months)
  • Well-being wil be assessed by the WHO-5 Well-being Index(18 months)
  • Number of seizures(18 months)
  • Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(18 months)
  • Side effects(18 months)
  • Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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