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