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Clinical Trials/NCT03628963
NCT03628963
Unknown
Not Applicable

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

Laval University1 site in 1 country200 target enrollmentSeptember 2018
ConditionsChronic Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Laval University
Enrollment
200
Locations
1
Primary Endpoint
Patient Activation
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2018
End Date
November 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie-Pierre Gagnon

Professor

Laval University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Majors whose incapacity has been recognised judically

Outcomes

Primary Outcomes

Patient Activation

Time Frame: 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).

Secondary Outcomes

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

Study Sites (1)

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