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Decision Aid + Standard Care for Malaria (OMDA Trial)

N/A
Waitlist Available
Led By Anne E McCarthy, MD, MSc
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

OMDA Trial Summary

BRIEF SUMMARY Canadians often visit areas with malaria where the preventative drug chloroquine no longer works. This leaves Canadians with the choice to use three different drugs to prevent malaria - atovaquone-proguanil, doxycycline, or mefloquine. There are more than 400 cases of malaria reported in Canada each year, a few which result in death. These cases mainly occur in people who do not take malaria pills as directed. Investigators have developed the Ottawa Malaria Decision Aid (OMDA), which is a bilingual (English and French) resource used to support malaria prevention decision-making. The OMDA contains plain language, fact-based information and helps individuals to reflect on their own values and beliefs so that they can make the best decision for their situation. In this randomized control study, the investigators will attempt to find out if using the OMDA before visiting a travel clinic affects decisional conflict and the way pills are taken. Consenting travellers will be assigned to standard care or standard care plus the malaria decision aid. Both groups will complete three questionnaires before and after travel to look at the impact on decisional conflict, preparation for decision-making, decisional regret and pill taking behaviour. Travelers' malaria can be prevented. It is our hope that by using different methods of presenting information, specifically by utilizing the OMDA, there will be an increase in adherence to appropriate malaria prophylaxis which will ultimately result in a decrease in malaria cases that arrive in Canada. This will translate into a decreased use of health care dollars and unnecessary deaths. The Objectives of this study are to evaluate whether the malaria decision aid can be integrated into the pre-travel consultation process and can: improve a traveller's knowledge of malaria and prevention strategies; improve a traveller's preparation for decision-making; decrease decisional conflict; and affect levels of adherence to prescribed malaria chemoprophylaxis. The hypotheses of this study are that: A decision aid will improve the quality of decision-making about malaria chemoprophylaxis by decreasing decisional conflict and increasing knowledge about malaria and malaria pills. Better decision quality will result in a greater level of adherence to prescribed malaria chemoprophylaxis.

OMDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Travellers' Knowledge Score
Secondary outcome measures
Decisional Conflict Score
Medication Adherence Score
Preparation for Decision-making Score

OMDA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Decision Aid + Standard CareExperimental Treatment1 Intervention
This group will receive the intervention (the Ottawa Malaria Decision Aid), in addition to standard medical care.
Group II: Standard CareActive Control1 Intervention
This arm will receive no intervention; only standard medical care.

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Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,787,617 Total Patients Enrolled
Charde A Morgan, MScPHStudy ChairOttawa Hospital Research Institute
Catherine Ivory, PhDStudy ChairUniversity of Ottawa, Faculty of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby May 2025