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Optimizing Patient Usability Experience for Chronic Care

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Concerto+
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring Diabetes, hypertension, dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Université Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Concerto+ (Intervention group)

Usual care (Control group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).

Full Information

First Posted
August 9, 2018
Last Updated
August 20, 2018
Sponsor
Laval University
Collaborators
Concerto Health Group Montréal, Qc, Canada, International Business Machines (IBM), Vrije Universiteit Brussel, Jette, Belgium, Université de Montréal, Haute Ecole de Santé Vaud (HESAV), Lausanne, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03628963
Brief Title
Optimizing Patient Usability Experience for Chronic Care
Official Title
Personalize Concerto: A Study Protocol for Optimizing Patient Usability Experience With an eHealth Platform for Embedded, Coordinated and Efficient Healthcare
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Concerto Health Group Montréal, Qc, Canada, International Business Machines (IBM), Vrije Universiteit Brussel, Jette, Belgium, Université de Montréal, Haute Ecole de Santé Vaud (HESAV), Lausanne, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Diabetes, hypertension, dyslipidemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concerto+ (Intervention group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care (Control group)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Concerto+
Intervention Description
a user-centered, multifunctional and personalized eHealth platform
Primary Outcome Measure Information:
Title
Patient Activation
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Process of care
Description
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.
Time Frame
9 months
Title
Acceptability
Description
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).
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Pierre Gagnon, Ph.D
Phone
418 525 4444
Ext
53169
Email
marie-pierre.gagnon@fsi.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mame Awa Ndiaye, M.A
Phone
4186635700
Ext
8082
Email
mame-awa.ndiaye.ciussscn@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre Gagnon, Ph.D
Organizational Affiliation
Faculty of Nursing, Université Laval, Quebec City, QC, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V0A6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre Gagnon, PhD
Phone
4186562131
Ext
7576
Email
marie-pierre.gagnon@ulaval.ca
First Name & Middle Initial & Last Name & Degree
MameAwa Ndiaye, MA
Phone
418-663-5700
Email
mame-awa.ndiaye.ciussscn@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21752267
Citation
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.
Results Reference
background
PubMed Identifier
16336556
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. doi: 10.1111/j.1475-6773.2005.00438.x.
Results Reference
background
PubMed Identifier
15838407
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. doi: 10.1097/01.mlr.0000160375.47920.8c.
Results Reference
background
Citation
Davis, F.D., Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS quarterly, 1989: p. 319-340
Results Reference
background
PubMed Identifier
30944143
Citation
Gagnon MP, Ndiaye MA, Larouche A, Chabot G, Chabot C, Buyl R, Fortin JP, Giguere A, Leblanc A, Legare F, Motulsky A, Sicotte C, Witteman HO, Kavanagh E, Lepinay F, Roberge J, Deletroz C, Abbasgholizadeh-Rahimi S. Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial. BMJ Open. 2019 Apr 2;9(4):e028554. doi: 10.1136/bmjopen-2018-028554.
Results Reference
derived

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Optimizing Patient Usability Experience for Chronic Care

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