跳至主要内容
临床试验/NCT05273580
NCT05273580已完成不适用

Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers

Royal North Shore Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Wearable compliance

研究概览

简要总结

Non-professional carers (typically family members) play a critical role in providing adequate home care. This research explores the use of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor stress levels of advanced cancer patient/carer dyads. During wear times, WS-triggered ecological momentary assessments (EMAs) were conducted via short smartphone-based surveys. This pilot study investigates the feasibility of EMAs in community palliative care.

详细描述

Non-professional carers (typically family members) play a critical role in providing adequate home care along with professional caregivers. However, the physical and emotional toll of caring for a family member can lead to distress and burn out of the carer. The latter often results in the need for temporary or permanent institutional care of the patient. This research explores the feasibility of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.

Throughout the study, wearable sensors are used to passively record physiological data from patient/carer dyads. During wear times, WS recordings trigger ecological momentary assessments (EMAs) conducted via surveys. This pilot investigates the feasibility and acceptability of EMAs in community palliative care and the potential for incorporating EMA-based interventions into routine care. Future studies may explore the possibility of ecological momentary interventions (EMIs) to trigger just-in-time targeted interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Palliative care patient attending at Northern Sydney Cancer Centre, RNSH
  • Patient and carer dyad
  • Both patient and carer consent
  • Patient Karnofsky Performance Scale ≥ 50
  • Patient and carer have compatible smart phone

排除标准

  • Unwilling or unable to give informed consent

结局指标

主要结局

Wearable compliance

时间窗: 5 weeks

Wearable compliance (compliance defined HR signal detected for \>=70% of daytime hours between 7:30am to 7:30 pm)

次要结局

  • Correlative analysis of WS signals and ePRO's(5 weeks)
  • Quantitative and qualitative exploration of EMA/EMI acceptability(2 hours)

研究者

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

Thilo Schuler

Principal Investigator

Royal North Shore Hospital

研究点 (1)

Loading locations...

相似试验

Wearable and Patient-reported Outcome-based... | 临床试验