Evaluating the Ottawa Malaria Decision Aid

NCT01976325 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-04-16

No results posted yet for this study

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:

1. 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.
2. Better decision quality will result in a greater level of adherence to prescribed malaria chemoprophylaxis.

Conditions

Interventions

OTHER

Ottawa Malaria Decision Aid

The Ottawa Malaria Decision Aid is a tool that helps patients become involved in decision making about which malaria prophylaxis pill is right for them to take. The decision aid provides information about the options for malaria chemoprophylaxis, information about the financial costs and time required to adhere to the course of preventative medication, and clarifies personal values. The decision aid is designed to complement counseling from a health practitioner.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Anne E McCarthy, MD, MSc · The Ottawa Hospital Research Institute

  • Catherine Ivory, PhD · University of Ottawa, Faculty of Medicine

  • Louise Balfour, PhD · Ottawa Hospital Research Institute

  • Charde A Morgan, MScPH · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976325 on ClinicalTrials.gov