Recruiting

Malaria Decision Aid

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT01976325

Conditions

Malaria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ottawa Malaria Decision Aid

Study Details

Brief 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

Malaria

Study ID

NCT01976325

Start date

Jan, 2014

Status verified date

Apr, 2015

Completion date

Nov, 2015

Anticipated

Primary completion date

Nov, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • An Adult 18 years of age or older
  • Individuals who have contacted the travel clinic at The Ottawa Hospital, General Campus, the National Capital Region Occupational Health Clinic or received study information from IAMAT before they travel
  • Travelling for less than one year
  • Departing for the trip in more than one week
  • Travelling to an area with known chloroquine-resistant malaria

Exclusion Criteria:

  • The travellers not visiting areas with chloroquine resistant malaria
  • Those travelling longer than one year
  • Departing for the trip in less than one week
  • Individuals younger than 18 years of age
  • Those who are pregnant or intend to become pregnant during their travel
  • Those who have severe kidney disease, severe liver disease, heart rhythm problems, or a history of seizures
  • Those who have a history of mental problems
  • Those who have an allergy to Atovaquone-proguanil, Doxycycline or Mefloquine
  • Those who are unable to understand written or spoken English or French due to deafness, blindness, cognitive impairment or language barrier

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard Care

This arm will receive no intervention; only standard medical care.

experimental: Decision Aid + Standard Care

This group will receive the intervention (the Ottawa Malaria Decision Aid), in addition to standard medical care.

Interventions

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.

Primary outcome measure

  • Travellers' Knowledge Score [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Charde A Morgan, MScPH

613-737-8899cmorgan@ohri.ca

Anne E McCarthy, MD, MSc

613-737-8899amccarthy@toh.on.ca

Locations

National Capital Region Occupational Health Clinic

Recruiting

Ottawa, Ontario, Canada, K1A 0K9

Contacts

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Charde A Morgan, MScPH

613-737-8899cmorgan@ohri.ca

Principal Investigator:

Anne E McCarthy, MD, MSc

International Association for Medical Assistance to Travellers

Recruiting

Toronto, Ontario, Canada, M6K 3E3

Contacts

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 16, 2015

Last verified

Apr, 2015

Keywords

  • decision aid
  • imported malaria
  • malaria prevention and control
  • malaria chemoprophylaxis
  • mefloquine
  • lariam
  • atovaquone-proguanil
  • malarone
  • doxycycline
  • vibramycin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2015-04-16.