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Outcome Measures

Primary Outcomes (1)

Feasibility of conducting the trial
Recruitment rate defined as the proportion of participants randomized divided by the proportion of eligible participants
within 30 days

Secondary Outcomes (3)

Adherence to the individual components of the hybrid strategy
within 30 days
Patient satisfaction with the hybrid strategy
within 30 days

Study Arms (2)

Hybrid strategy

EXPERIMENTAL

A hybrid strategy inclusive of: 1. A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects 2. Alerting patients on polluted days (defined as air quality index (AQI) ≥ 131 \[33\]) by sending cell phone text messages and recommending to not go outdoors or minimize outdoor activities (especially exercising) on those days. This will also be accompanied by periodic phone calls to ascertain that the patients receive the messages and are attentive to them. 3. Wearing KN-95 facemasks (provided by the investigators of this study) as a physical barrier against air pollution on highly polluted days (defined as AQI ≥ 131) in case the patient cannot avoid going outdoors 4. Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131.

Other: Hybrid strategy

Usual care

NO INTERVENTION

No active strategy (usual care) without any clear recommendations related to air pollution. A control card will be shared with the patients randomized to the control group

Interventions

Hybrid strategyOther

Hybrid strategy

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MeSH Terms

Conditions

AtherosclerosisCoronary Artery DiseasePeripheral Arterial DiseaseIschemic StrokeCarotid Artery DiseasesCardiovascular DiseasesMyocardial Infarction

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesPeripheral Vascular DiseasesStroke

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

OTHER

Intervention Model

PARALLEL

Model Details: Participants undergo permuted block randomization with block sizes of four via a web-based system will be used for the study, in a 1:1 ratio between the hybrid strategy or control arms.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Associate professor

Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Hybrid strategy

Usual care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Hybrid strategy

Usual care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Data Sharing

Source record

Locations