Optimizing Patient Usability Experience for Chronic Care

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03628963
• Other study ID #: 2018-067/01-06-2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: November 2019

Study information

• Verified date: August 2018
• Source: Laval University
• Contact: Marie-Pierre Gagnon, Ph.D
• Phone: 418 525 4444
• Email: marie-pierre.gagnon[@]fsi.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Device:
• Concerto+
a user-centered, multifunctional and personalized eHealth platform

Locations

Country	Name	City	State
Canada	Université Laval	Quebec City	Quebec

Sponsors (6)

Lead Sponsor	Collaborator
Laval University	Concerto Health Group Montréal, Qc, Canada, Haute Ecole de Santé Vaud (HESAV), Lausanne, Switzerland, International Business Machines (IBM), Université de Montréal, Vrije Universiteit Brussel, Jette, Belgium

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Davis, F.D., Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS quarterly, 1989: p. 319-340

Fortin M, Contant E, Savard C, Hudon C, Poitras ME, Almirall J. Canadian guidelines for clinical practice: an analysis of their quality and relevance to the care of adults with comorbidity. BMC Fam Pract. 2011 Jul 13;12:74. doi: 10.1186/1471-2296-12-74. — View Citation

Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. — View Citation

Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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