NCT07543718

Brief Summary

Physicians' interventions to promote the improvement of lifestyle habits have been shown to be effective. However, such interventions remain underutilized due to barriers such as lack of time, confidence, and compensation. Group medical visits (GMVs) can help overcome several of these barriers and effectively improve clinical indicators as well as patients' quality of life. GMVs could also reduce pressure on the healthcare system by improving access to primary care through a more efficient use of resources. The literature suggests that GMVs can be effective in improving access to care and reducing disease complications for patients with several conditions and risk factors, but they have not been assessed specifically among patients with dyslipidemia, which is at the origin of most cases of cardiovascular diseases. In this context, GMVs will be implemented among 144 patients with dyslipidemia. The objective for this project is to evaluate implementation of GMVs. The implementation evaluation will follow the RE-AIM framework. These steps will position the research team to develop more complex and large-scale studies in lifestyle medicine. In the meantime, the project will contribute to improve access to primary care for the prevention of cardiovascular diseases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Dec 2030

First Submitted

Initial submission to the registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 22, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 27, 2026

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lipid profile

    Low-Density Lipoprotein; High-Density Lipoprotein; Total cholesterol; Triglycerides

    12 months

Secondary Outcomes (12)

  • Recruitment proportion

    12 months

  • Representativeness of eligible patients

    12 months

  • Attitudes of health professionals towards GMVs

    12 months

  • Frequency of access to healthcare

    12 months

  • Patients' self-efficacy

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention consists of regular care supplemented by a series of group medical visits (GMVs). Each series of GMVs will last 9-12 months and will include eight sessions of 90-120 minutes covering topics related to lifestyle medicine within the context of dyslipidemia management. These sessions will be offered to groups of 8 to 12 patients and delivered by a mix of family physicians, dietitians, kinesiologists, and psychologists, all trained to deliver GMVs. Each session will begin with a revision of the goals established in the previous session, followed by a didactic component including demonstrations, questioning, and experiential activities. Emphasis will be placed on health self management and on developing realistic, specific, and observable personal goals. The sessions will include opportunities for social interaction among participants and will offer opportunities for brief one on one consultations patients and health professionals if needed.

Behavioral: Group medical visits

Usual care group

NO INTERVENTION

Participants in the usual-care group will have access to their regular follow-up with their primary care providers. They will also have the option to take part in the GMVs after the project's final evaluation period.

Interventions

Group medical visits are designed to improve knowledge of participants and promote self-management.

Intervention group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of dyslipidemia according to the guidelines of the Canadian Cardiovascular Society, i.e., at a minimum: an intermediate cardiovascular risk according to the Framingham Risk Score (10-19.9%) WITH LDL-C ≥ 3.5 mmol/L or non-HDL-C ≥ 4.2 mmol/L or ApoB ≥ 1.05 g/L

You may not qualify if:

  • Patients unable to participate in GMV sessions or to provide informed consent
  • Patients with a mental health condition likely to limit their ability to benefit from GMV sessions and discussions (Examples: severe dementia or an acute psychiatric decompensation occurring within the past six months)
  • A diagnosis of terminal illness or a life expectancy of less than 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de médecine familiale du Grand-Moncton

Dieppe, New Brunswick, E1A1G6, Canada

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 22, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Once the study is completed, the data will be available through data sharing agreements.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
within 12 months after publication of the main results.

Locations