Optimization of the Management of COVID-19 Through Tailored Recommendations to the Citizens

NCT04699851 | Unknown DMC

• 1 other identifier: vigie-covid
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

People with chronic diseases including atherosclerotic heart disease, high blood pressure and diabetes are considered as a group with a high vulnerability. The COVID-19 pandemic ranging the world is rendering these people with chronic diseases even more vulnerable as they are subjected to a higher risk of COVID-19 related complications. General recommendations issued by the public health departments (PHD) do not take into consideration the personal situation of every citizen and therefore do not provide a personalized guidance to people with high vulnerability. The investigators hypothesis is that if participants receive adapted and personalized public health recommendations, they will be more adherent to the recommendations issued by the PHD and have better health outcomes than those who receive only general recommendations. In the current trial, the investigators propose to co-develop a web-based portal (Vigie-COVID) that provides tailored recommendations based on the situation of each participant and adapted to the COVID-19 status, the behavior risk associated to contamination, the risk of complications and the health risks related to confinement. Using a cohort of people aged 18 and over in the province of Quebec, this randomized clinical trial will use a nested a double-blind experimental design where the tailored recommendations will be compared to the general recommendations of the PHD. The expected results from this trial include: 1) Improvement in the rate of compliance with the PHD recommendations in the group receiving the tailored recommendations; 2) Improvement of the quality and the quantity of the COVID 19 epidemiological data available for population health research in the Quebec region; 3) Decrease in the load in clinics (self-diagnosis); 4) Improving the state of health of individuals. The portal will be co-constructed in collaboration between various key players (citizens, patient partners, clinicians, researchers, companies, managers, decision-makers and representatives of the PHD) and aims to allow the recommendations of the PHD to be tailored according to the specific situation of each citizen-user in order to promote preventive behavior in times of pandemic. Overall, the ultimate goal is to obtain a global epidemiological portrait in order to identify the determinants and indicators of sustainable health and their impacts. After the pandemic, this might enable the implementation of a personalized monitoring of chronic diseases.

Conditions

COVID19; Tailored Recommendations; Citizen Self-reported Symptoms

Outcome Measures

Primary Outcomes (6)

• improvement in mask wearing behavior

  The measure will be the frequency of mask wearing when the participant is in a situation where it is recommended by public health to wear the mask

  3 months

• improvement in social distancing behavior

  The measure will be the frequency of social distancing (2 meters or more) when the participant is in a situation where it is recommended by public health.

  3 months

• improvement in hand washing behavior

  The measure will be the frequency of hand washing when the participant is in a situation where it is recommended by public health.

  3 months

• improvement in daily fruit consumption

  the measure will be the portion of fruit and vegetables consumed per day

  3 months

• improvement in the amount of daily sleep hours

  The measure will be the amount of hour of sleep by day

  3 months

• improvement in the amount of weekly minutes of exercise

  The measure will be the amount of minutes of moderate to intense exercise by week

  3 months

Secondary Outcomes (3)

• Platform participation

  3 months

• Platform sustainability short term

  3 weeks

• Platform sustainability long term

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm are participants who will receive tailored recommendations about health prevention in a pandemic based on their answers in the survey.

Behavioral: Tailored recommendations

Control

ACTIVE COMPARATOR

The control group will receive general recommendations about health prevention in a pandemic.

Behavioral: General recommendation

Interventions

Tailored recommendations BEHAVIORAL

Tailored informations delivered by email about health prevention behavior in a pandemic based on the answers in the survey.

Intervention

General recommendation BEHAVIORAL

The control group will receive general recommendations by email about health prevention in a pandemic.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Living in Canada
• Able to give an informed consent

You may not qualify if:

• none

Sponsors & Collaborators

• Laval University: lead
• Réseau-1 Québec: collaborator
• Réseau de recherche en santé des populations du Québec: collaborator

Study Sites (1)

Laval University

Québec, g1v0a6, Canada

RECRUITING

Related Publications (10)

• Lustria ML, Noar SM, Cortese J, Van Stee SK, Glueckauf RL, Lee J. A meta-analysis of web-delivered tailored health behavior change interventions. J Health Commun. 2013;18(9):1039-69. doi: 10.1080/10810730.2013.768727. Epub 2013 Jun 10.

  PMID: 23750972 BACKGROUND

• Williams SN, Armitage CJ, Tampe T, Dienes K. Public perceptions and experiences of social distancing and social isolation during the COVID-19 pandemic: a UK-based focus group study. BMJ Open. 2020 Jul 20;10(7):e039334. doi: 10.1136/bmjopen-2020-039334.

  PMID: 32690752 BACKGROUND

• Islam AKMN, Laato S, Talukder S, Sutinen E. Misinformation sharing and social media fatigue during COVID-19: An affordance and cognitive load perspective. Technol Forecast Soc Change. 2020 Oct;159:120201. doi: 10.1016/j.techfore.2020.120201. Epub 2020 Jul 12.

  PMID: 32834137 BACKGROUND

• Chow EJ, Schwartz NG, Tobolowsky FA, Zacks RLT, Huntington-Frazier M, Reddy SC, Rao AK. Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. 2020 May 26;323(20):2087-2089. doi: 10.1001/jama.2020.6637.

  PMID: 32301962 BACKGROUND

• Stringhini S, Wisniak A, Piumatti G, Azman AS, Lauer SA, Baysson H, De Ridder D, Petrovic D, Schrempft S, Marcus K, Yerly S, Arm Vernez I, Keiser O, Hurst S, Posfay-Barbe KM, Trono D, Pittet D, Getaz L, Chappuis F, Eckerle I, Vuilleumier N, Meyer B, Flahault A, Kaiser L, Guessous I. Seroprevalence of anti-SARS-CoV-2 IgG antibodies in Geneva, Switzerland (SEROCoV-POP): a population-based study. Lancet. 2020 Aug 1;396(10247):313-319. doi: 10.1016/S0140-6736(20)31304-0. Epub 2020 Jun 11.

  PMID: 32534626 BACKGROUND

• Zheng Z, Peng F, Xu B, Zhao J, Liu H, Peng J, Li Q, Jiang C, Zhou Y, Liu S, Ye C, Zhang P, Xing Y, Guo H, Tang W. Risk factors of critical & mortal COVID-19 cases: A systematic literature review and meta-analysis. J Infect. 2020 Aug;81(2):e16-e25. doi: 10.1016/j.jinf.2020.04.021. Epub 2020 Apr 23.

  PMID: 32335169 BACKGROUND

• Ammar A, Brach M, Trabelsi K, Chtourou H, Boukhris O, Masmoudi L, Bouaziz B, Bentlage E, How D, Ahmed M, Muller P, Muller N, Aloui A, Hammouda O, Paineiras-Domingos LL, Braakman-Jansen A, Wrede C, Bastoni S, Pernambuco CS, Mataruna L, Taheri M, Irandoust K, Khacharem A, Bragazzi NL, Chamari K, Glenn JM, Bott NT, Gargouri F, Chaari L, Batatia H, Ali GM, Abdelkarim O, Jarraya M, Abed KE, Souissi N, Van Gemert-Pijnen L, Riemann BL, Riemann L, Moalla W, Gomez-Raja J, Epstein M, Sanderman R, Schulz SV, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Simunic B, Pisot R, Gaggioli A, Bailey SJ, Steinacker JM, Driss T, Hoekelmann A. Effects of COVID-19 Home Confinement on Eating Behaviour and Physical Activity: Results of the ECLB-COVID19 International Online Survey. Nutrients. 2020 May 28;12(6):1583. doi: 10.3390/nu12061583.

  PMID: 32481594 BACKGROUND

• Altena E, Baglioni C, Espie CA, Ellis J, Gavriloff D, Holzinger B, Schlarb A, Frase L, Jernelov S, Riemann D. Dealing with sleep problems during home confinement due to the COVID-19 outbreak: Practical recommendations from a task force of the European CBT-I Academy. J Sleep Res. 2020 Aug;29(4):e13052. doi: 10.1111/jsr.13052. Epub 2020 May 4.

  PMID: 32246787 BACKGROUND

• Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.

  PMID: 32220590 BACKGROUND

• DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9.

  PMID: 15076819 BACKGROUND

Related Links

• Main website for the project, it explain the project and links to the research platform
• Données COVID-19 au Québec. Institut national de santé publique du Québec (INSPQ)
• Avis provisoire du 14 mars 2020. relatif à la prise en charge des patients à risque de forme sévère de Covid-19
• Roy S, 2020. Coronavirus: l'inquiétante baisse des consultations médicales en ville. Le Figaro
• Statistique Canada. Enquête internationale sur l'alphabétisation et les compétence des adultes (EIA CA) 2003
• Aire de diffusion : définition détaillée. Statistique Canada.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Sébastien Paquette

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Sébastien Paquette, MD

CONTACT

450-759-3060; jean-sebastien.paquette@fmed.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant do not know if they received tailored or general recommendations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The project has 2 arms. The intervention arm are participant who will receive tailored recommendations about health prevention in a pandemic based on their answers in the survey. The control group will receive general recommendations about health prevention in a pandemic.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: January 7, 2021
• Study Start: November 18, 2020
• Primary Completion: April 18, 2021
• Study Completion: May 18, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

CA (1)