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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Université Laval | Quebec City | Quebec |
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 |
Canada,
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
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 |
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