Optimizing Patient Usability Experience for Chronic Care

Study 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.

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

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Device: Concerto+


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two Family Medicine Groups (FMG) from the same health region but covering distinct areas have been selected as the clusters. The FMGs will be randomily selected for the experimental (CONCERTO+) or control (usual care) group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concerto+ (Intervention group)<br>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. | Device: Concerto+<br>* a user-centered, multifunctional and personalized eHealth platform<br>|
| No Intervention: Usual care (Control group)<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation | 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: Not believing that activation is important (≤ 47) Lack of knowledge or confidence to take action (47.1 - 55.1) Beginning to take action (55.2 - 67) Taking action (≥ 67.1). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process of care | The effects of the use of Concerto + will be assessed and measured, using an adapted version of a survey from Glasgow et al. [3] and validated in the previous CHP (Concerto Health Program) assessment. Patients answer to a questionnaire six months after the use of Concerto+. 5 scales based on the key components of Concerto + are defined, and each scale include items: Solving-problems/Advices (4 items), Delivery System Design/Decision support (3 items), Goal Setting/Tailoring (5 items), Follow-up/coordination (5 items), Overall care (9 items). Items are scored on a 5-point scale ranging from 1 (Almost never) to 5 (Almost always), through following subscales 2 (Generally not); 3 (Sometimes); 4 (Most of the time). Higher scores from the assessment survey have better effects in care outcomes. | 9 months | 
| Acceptability | The acceptability of the device Concerto+ will be assessed by patient and informal caregiver, at the end of the intervention with: A short survey adapted from the Technology Acceptance Model [4] that includes 3 criteria (perceived ease of use, perceived usefulness, behavioral intention to use) with the following scoring: Strongly disagree = 1; Disagree = 2; Agree = 3; strongly agree = 4. Higher scores rates have a better acceptance of the use of Concerto+. The use of CONCERTO+ that will be measured by logs (Tests numbers, emergency visits, hospitalizations). | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, hypertension, dyslipidemia