Un Modello di Presa in Carico Continua Del Paziente Fragile
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Azienda Sanitaria Locale CN2 Alba-Bra
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance
概览
简要总结
This observational study aims to monitor functional status and identify potential declines in the functioning of medically fragile patients with neurological and/or orthopedic conditions, representing an added value for ensuring appropriate patient management. This approach improves system efficiency and supports a proactive strategy that promotes the appropriate use of resources.
详细描述
This is a prospective, observational, non-profit study.
Primary Objective:
To compare functional and cognitive test results at discharge from "La Residenza" rehabilitation center (Rodello - CN- Italy) with remote assessments at patients' homes, demonstrating that Timed Up and Go (TUG) and GPCog tests, validated in-person, can be reliably administered via telemedicine.
Secondary Objectives:
To monitor motor and cognitive function remotely at 3, 6, and 12 months after discharge, assessing clinical course and disease progression, and evaluating patient condition as stable, improved, or deteriorated.
Study Timeline and Sample Size:
Recruitment is expected from September 2025 to March 2026, with last follow-up in March 2027 and an additional 6 months for data analysis and publication. A total of 100 patients (50 orthopedic, 50 neurological) will be enrolled, accounting for a 25% expected loss, based on power calculations for paired t-tests comparing in-person and remote assessments.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance
时间窗: 5-10 days after discharge
Percentage of patients for whom the Timed Up and Go (TUG) test differs by less than 3.5 seconds and the GPCog test differs by less than 3 points between in-person and telemedicine assessments.
次要结局
- Timed Up and Go (TUG) Test Performance(3, 6, and 12 months after discharge)
- General Practitioner Assessment of Cognition (GPCog) Score(3, 6, and 12 months after discharge)
- SF-36 Composite Scores (Physical and Mental Component Summaries)(At discharge and 12 months after discharge)
- Modified Rankin Scale (mRS)(Baseline and 12 months after discharge)
- Barthel Index for Activities of Daily Living(Baseline and 12 months after discharge)
- Patient Satisfaction With Remote Monitoring(3, 6, and 12 months after discharge)
- Caregiver Satisfaction With Remote Monitoring(3, 6, and 12 months after discharge)