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临床试验/NCT03263169
NCT03263169Unknown不适用

A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults

Windsor-Essex Compassionate Care Community1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,100
试验地点
1
主要终点
Quality of Life

研究概览

简要总结

A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology.

The primary research question is: What is the effectiveness of the WECCC approach on quality of life in people aged 65 and older or who self-identify as disabled compared to people not receiving the Health TAPESTRY program?

详细描述

Secondary research questions include:

  1. what is the feasibility of obtaining study measures through routinely collected program participant data and what design adjustments are needed to balance pragmatism and high quality data collection?
  2. What are the analytic approaches to be developed to aggregate data from individual participants into meaningful units (e.g. care-team level, organizational level, social network, and geographic area) to inform ongoing adaptation of the components of the intervention?
  3. what are the perceptions of knowledge users on the usefulness of comparative effectiveness pragmatic trial evidence?

The project involves using administrative data from the ICES to create outcome measures and feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system integration, care in the community, and knowledge translation.

Inclusion criteria: Seniors (65+) and people who self-identify as having a functional disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex County in Ontario. The combined total eligible population in all 8 sites is about 60,000 people, from which a minimum sample of 3000 registered patients and 1000 registered caregivers will be drawn

In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all recruitment methods in the care model intervention, with similar numbers of control and intention to treat clients.

研究设计

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

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

  • Individuals who:
  • are 65 years of age and over
  • have a long-term disability or one or more chronic diseases
  • able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement

排除标准

  • Individuals not meeting above criteria

结局指标

主要结局

Quality of Life

时间窗: Baseline and then monthly for 24 months

McGill QoL - patient and family

Perceived health

时间窗: Baseline and then monthly for 24 months

EQ-5D-5L - patient

次要结局

  • Symptom management 1(Baseline and then monthly for 24 months)
  • Health services utilization 1(Baseline and then monthly for 24 months)
  • Symptom management 2(Baseline and then monthly for 24 months)
  • Caregiver Burden 2(Baseline and then monthly for 24 months)
  • Symptom management 3(Baseline and then monthly for 24 months)
  • Health services utilization 2(Baseline and then monthly for 24 months)
  • Caregiver Burden 1(Baseline and then monthly for 24 months)
  • Patient experience(Baseline and then monthly for 24 months)
  • Family experience(Baseline and then monthly for 24 months)

研究者

发起方
Windsor-Essex Compassionate Care Community
申办方类型
Other
责任方
Sponsor

研究点 (1)

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