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Chronic DiseaseNCT03628963

Optimizing Patient Usability Experience for Chronic Care

A study testing Concerto+ in people with Chronic Disease, run by Laval University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Concerto+
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
Sep 2018to Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Majors whose incapacity has been recognised judically

Trial locations and contacts

1 site in 1 country.

Marie-Pierre Gagnon, Ph.D contact

418 525 4444 ext. 53169

marie-pierre.gagnon@fsi.ulaval.ca

Mame Awa Ndiaye, M.A contact

4186635700 ext. 8082

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

Canada1 site

  • Université Laval

    Québec, Quebec, G1V0A6

    Marie-Pierre Gagnon, PhD, 4186562131 ext. 7576, marie-pierre.gagnon@ulaval.ca

    MameAwa Ndiaye, MA, 418-663-5700, mame-awa.ndiaye.ciussscn@ssss.gouv.qc.ca

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Chronic Disease
Being tested
Concerto+
Keywords
Diabetes, hypertension, dyslipidemia
Medical subject headings
Chronic Disease, Diabetes Mellitus, Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concerto+Device

    a user-centered, multifunctional and personalized eHealth platform

Study groups in NCT03628963
Study groupRoleWhat they receive
Concerto+ (Intervention group)ExperimentalPatients 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.
Receives: Device: Concerto+
Usual care (Control group)No interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (2)

  1. 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.

    Measured: 9 months

  2. Acceptability

    The acceptability of the device Concerto+ will be assessed by patient and informal caregiver, at the end of the intervention with:

    1. 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+.
    2. The use of CONCERTO+ that will be measured by logs (Tests numbers, emergency visits, hospitalizations).

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study startSep 2018 (estimated)
  3. Primary completionJan 2019 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628963
Sponsor's protocol ID
2018-067/01-06-2018
Status last verified
Aug 2018
First submitted
9 Aug 2018
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21752267

  • 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.

    PubMed 16336556

  • 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.

    PubMed 15838407

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

  • 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.

    PubMed 30944143

Questions about this trial

What is this clinical trial studying?

A study testing Concerto+ in people with Chronic Disease, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-Pierre Gagnon, Ph.D (418 525 4444 ext. 53169, marie-pierre.gagnon@fsi.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Activation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03628963, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.

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