Optimizing Patient Usability Experience for Chronic Care

NCT03628963 | Unknown DMC

• 1 other identifier: 2018-067/01-06-2018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Diabetes; hypertension; dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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: 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).

  6 months

Secondary Outcomes (2)

• Process of care

  9 months

• Acceptability

  9 months

Study Arms (2)

Concerto+ (Intervention group)

EXPERIMENTAL

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+

Usual care (Control group)

NO INTERVENTION

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.

Interventions

Concerto+ DEVICE

a user-centered, multifunctional and personalized eHealth platform

Concerto+ (Intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Majors whose incapacity has been recognised judically

Sponsors & Collaborators

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

Study Sites (1)

Université Laval

Québec, Quebec, G1V0A6, Canada

Location

Related Publications (5)

• 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.

  PMID: 21752267 BACKGROUND

• 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.

  PMID: 16336556 BACKGROUND

• 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.

  PMID: 15838407 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 30944143 DERIVED

MeSH Terms

Conditions

Chronic Disease; Diabetes Mellitus; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Officials

• Marie-Pierre Gagnon, Ph.D

  Faculty of Nursing, Université Laval, Quebec City, QC, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Pierre Gagnon, Ph.D

CONTACT

418 525 4444; marie-pierre.gagnon@fsi.ulaval.ca

Mame Awa Ndiaye, M.A

CONTACT

4186635700; mame-awa.ndiaye.ciussscn@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)