MAVIPAN: My Life and the COVID-19 Pandemic

October 2, 2020 updated by: Annie Leblanc, Laval University

The MAVIPAN Protocol: For a Structured Response to the Psychosocial Consequences of the Restrictive Measures Imposed by the Global Health COVID-19 Pandemic

The health crisis imposed by COVID-19 is forcing major worldwide social reorganization that will have profound consequences on our society. Currently, one-third of the world's population (~3 billion individuals) is living under some kind of isolation or quarantine measures, causing an unprecedented and rapidly evolving psychosocial crisis.

The psychosocial consequences of this health crisis will persist long after restriction measures are lifted and the pandemic is over. This impact will be significant for individuals facing unique contexts or challenges (e.g., older adults, individuals living with a disability, underprivileged families) and will most likely exacerbate existing social and gender inequalities in health and human development.

There is an urgent need for information on the evolution of the psychosocial dimensions of health and coping strategies used by our population and our health and social services structures. Thus, this study is designed to accelerate the availability of high-quality, real-time evidence within health and social services structures to address, support and minimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolving research questions responsive to the course of the pandemic evolution, the rapid system transformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aims to address, document, monitor, and evaluate the following:

  1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts.
  2. Healthcare and social services workers and managers' adjustments and mitigation strategies.
  3. The organization of service structures.
  4. The social and economic response.

To achieve these objectives, we use a mixed methods study design that combines quantitative questionnaires and qualitative interviews to deepen our understanding of elements such as the coping strategies used during the pandemic. A first measure was taken during lock-down as well as a follow-up at 3 months. Another follow-up will be made at 7 months. At least one per year follow-up will be made over the course of the study (5 years). Additional measures may be taken depending on the evolution of the pandemic and the sanitary measures put in place by the authorities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada, G1J 0A4
        • Recruiting
        • VITAM-Research Center in Sustainable Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MAVIPAN is open to any individuals aged 14 and over across the Province of Quebec. We are particularly invested in recruiting vulnerable populations (e.g., older adults, individuals living with a disability or a chronic or mental health condition, child protection families, individuals living in institutional settings) and populations that have become vulnerable because of the COVID-19 context (e.g., healthcare and social services workers, adolescents, caregivers).

Description

Inclusion Criteria:

  • General population

Exclusion Criteria:

  • Not a resident of the province of Quebec
  • Age under 14

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time Frame: Baseline (measured during lockdown in March 2020)
The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms.
Baseline (measured during lockdown in March 2020)
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time Frame: 3 months
The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms.
3 months
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time Frame: 7 months
The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms.
7 months
Insomnia Severity Index
Time Frame: Baseline (measured during lockdown in March 2020)
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Baseline (measured during lockdown in March 2020)
Insomnia Severity Index
Time Frame: 3 months
Scores vary between 0 and 28. A higher score means greater insomnia severity.
3 months
Insomnia Severity Index
Time Frame: 7 months
Scores vary between 0 and 28. A higher score means greater insomnia severity.
7 months
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: Baseline (measured during lockdown in March 2020)
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Baseline (measured during lockdown in March 2020)
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 3 months
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
3 months
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 7 months
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
7 months
Hostility subscale- Symptoms Checklist-90-Revised
Time Frame: Baseline (measured during lockdown in March 2020)
Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility
Baseline (measured during lockdown in March 2020)
Hostility subscale- Symptoms Checklist-90-Revised
Time Frame: 3 months
Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility
3 months
Hostility subscale- Symptoms Checklist-90-Revised
Time Frame: 7 months
Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility
7 months
Substance use
Time Frame: Baseline (measured during lockdown in March 2020)
These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown.
Baseline (measured during lockdown in March 2020)
Substance use
Time Frame: 3 months
These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown.
3 months
Substance use
Time Frame: 7 months
These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown.
7 months
Brief COPE
Time Frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions taken from the Brief Cope which measures coping strategies.
Baseline (measured during lockdown in March 2020)
Dyadic Adjustment Scale
Time Frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions taken from the Dyadic Adjustment Scale which measures couple satisfaction.
Baseline (measured during lockdown in March 2020)
Parental Stress Index
Time Frame: Baseline (measured during lockdown in March 2020)
We only use the Interaction subscale which measures the extent to which the parent believes the child is not meeting expectations and finds interactions with the child are not reinforcing his parenting role.
Baseline (measured during lockdown in March 2020)
Child Conflict Tactic Scale
Time Frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions that measures the presence of minor physical abuse as well as psychological abuse.
Baseline (measured during lockdown in March 2020)
Strengths and Difficulties Questionnaire
Time Frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions that aim to measure different child behaviors and personality caracteristics.
Baseline (measured during lockdown in March 2020)
Healthcare workers adaptation
Time Frame: Baseline (measured during lockdown in March 2020)
We use a series of questions that assess different changes that may have occured in their work, as well as a series of beliefs they may hold concerning their work and their patients/clients.
Baseline (measured during lockdown in March 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CISSS de Chaudière-Appalaches
VITAM: Research Center on Sustainable Health
Centre de recherche CERVO
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
Centre de recherche universitaire sur les jeunes et les familles
Réseau québécois de recherche sur le vieillissement
Participation sociale et villes inclusives
Société inclusive
Centre intégré de santé et de services sociaux de la Côte-Nord
Fondation Mirella et Lino Saputo
Ville de Québec
Living Lab de Charlevoix
Centre intégré de santé et de services sociaux du Bas St-Laurent
Réseau provincial de recherche en adaptation réadaptation
Réseau international sur le Processus de production du handicap
Centre de recherche intégrée pour un système apprenant en santé et services sociaux
Regroupement des organismes de personnes handicapées de la région 03

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Annie LeBlanc, PhD, Faculty of Medecine, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • To be assigned (EGMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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