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临床试验/NCT03628963
NCT03628963Unknown不适用

Personalize Concerto: A Study Protocol for Optimizing Patient Usability Experience With an eHealth Platform for Embedded, Coordinated and Efficient Healthcare

Laval University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Patient Activation

研究概览

简要总结

The study aims to develop a module of an eHealth platform, do a feasibility study through a pilot cluster randomized control trial and assess the scalability of the solution.

详细描述

Multimorbidity increases care needs and primary care use among people with chronic diseases (1). The Concerto Health Program (CHP) has been developed to optimize chronic disease management in primary care services. However, in its current version, the CHP primarily targets clinicians and does not aim to respond directly to the needs of patients and their informal caregivers for chronic disease management . This project aims to develop, implement and evaluate a user-centered, multifunctional and personalized eHealth platform (CONCERTO+) to promote a more active patient role in chronic disease management and decision-making through three phases.

For phase1: A first prototype will be developed by the design and technology teams, in close collaboration with researchers, health professionals and patient representatives who will identify the functionalities to include in the CONCERTO+ solution.

The Phase 2 of the project will consist in a feasibility study based on a pilot cluster randomized clinical trial (c-RCT) where patients with chronic diseases from a primary healthcare practice will receive CONCERTO+ and be compared to patients from a control practice receiving usual care.

For Phase 3, the analysis of CONCERTO+ potential for scaling-up will be done by documenting factors and conditions associated with the sustainability and scaling-up of the solution. To do so, the investigators will conduct: 1) two focus groups with patients and informal caregivers who participated in the study (one with the experimental group and one with the control group, each group gathering between eight and twelve participants); 2) semi-structured individual interviews with health professionals at the two study sites, as well as with health care managers, information officers, and representatives of the Ministry of Health and Social Services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Having one or more targeted chronic diseases (diabetes, hypertension, dyslipidemia)
  • had 3 or more visits in the last 12 months
  • having an interest in health and technologies,
  • be able to read and speak in French

排除标准

  • Majors whose incapacity has been recognised judically

研究组 & 干预措施

Concerto+ (Intervention group)

Experimental

Patients with two or more targeted chronic diseases (diabetes, hypertension, dyslipidemia) and who had three or more visits in the last 12 months will use Concerto+ application during 6 months.

干预措施: Concerto+ (Device)

Usual care (Control group)

No Intervention

Patients with two or more targeted chronic diseases (diabetes, hypertension, dyslipidemia) and who had three or more visits in the last 12 months will not use the application Concerto+ but receive usual care from FMG.

结局指标

主要结局

Patient Activation

时间窗: 6 months

The Patient Activation Measure -13 (2) is built on patient knowledge, skills and confidence that are directly targeted by the intervention and is associated to their activation level. Patients who are more activated have better health outcomes. Patients answer to a survey of 13 questions with the following scoring for each answer: Strongly disagree = 1; Disagree = 2; Agree = 3; strongly agree = 4 The score of the activation level obtained (between 0 and 100) shows the degree of ability to manage their health with confidence according to the following scale ranges: 1. Not believing that activation is important (≤ 47) 2. Lack of knowledge or confidence to take action (47.1 - 55.1) 3. Beginning to take action (55.2 - 67) 4. Taking action (≥ 67.1).

次要结局

  • Process of care(9 months)
  • Acceptability(9 months)

研究者

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

Marie-Pierre Gagnon

Professor

Laval University

研究点 (2)

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