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Evaluating the Ottawa Malaria Decision Aid (OMDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01976325
Recruitment Status : Unknown
Verified April 2015 by Ottawa Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : November 5, 2013
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Malaria Other: Ottawa Malaria Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incorporation of the 'Ottawa Malaria Decision Aid' Into the Pre-travel Consultation Process: Assessment of Travelers' Knowledge, Decisional Conflict, Preparation for Decision-making and Medication Adherence Compared to Standard Care
Study Start Date : January 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Travellers' Knowledge Score [ Time Frame: One year ]
    The traveller's knowledge score will be calculated based on participant's answers to questions from the Ottawa Malaria Knowledge Scale (2007) and the Realistic Expectations Scale (O'Connor 1996). For each multiple choice question, every possible response contains a predetermined scoring scheme. The traveller's knowledge score is calculated by adding points from each question answered. The sum of points forms the traveller's knowledge score.


Secondary Outcome Measures :
  1. Decisional Conflict Score [ Time Frame: One year ]
    The decisional conflict score will be measured based on responses in the questionnaire using specific questions from the Decisional Conflict Scale (O'Connor, 1993, revised 2005), the Medical Decision Making Scale (Adapted from Strull, 1984), the Values Scale (Adapted from O'Connor 1999), and the Decision Regret Scale (O'Connor, 1996). For each scaled question, every possible response contains a predetermined scoring scheme. The score is calculated by adding points from each question answered. The sum of points forms the score.

  2. Preparation for Decision-making Score [ Time Frame: One year ]
    The preparation for decision making score will be measured based on responses in the questionnaire using specific questions from the Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005), and the Choice Predisposition Scale (O'Connor 2000). For each scaled question, every possible response contains a predetermined scoring scheme. The score is calculated by adding points from each question answered. The sum of points forms the score.

  3. Medication Adherence Score [ Time Frame: One year ]
    Medication adherence will be measured based on responses in the after-travel questionnaire using specific questions from the adapted ACTG Adherence questionnaire, and the Malaria Adherence Prophylactic Scale (MAPS). For each multiple choice and scaled question, every possible response contains a predetermined scoring scheme. The score is calculated by adding points from each question answered. The sum of points forms the score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976325


Contacts
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Contact: Charde A Morgan, MScPH 613-737-8899 ext 72424 cmorgan@ohri.ca
Contact: Anne E McCarthy, MD, MSc 613-737-8899 ext 78184 amccarthy@toh.on.ca

Locations
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Canada, Ontario
National Capital Region Occupational Health Clinic Recruiting
Ottawa, Ontario, Canada, K1A 0K9
Contact: Louise J Levesque, RN, BScN    613-946-5533    louise.j.levesque@hc-sc.gc.ca   
Contact: Lisa Taras, MD, CCFP    613-946-6583    lisa.taras@hc-sc.gc.ca   
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Charde A Morgan, MScPH    613-737-8899 ext 72424    cmorgan@ohri.ca   
Contact: Anne E McCarthy, MD    613-737-8899 ext 78184    amccarthy@toh.on.ca   
Principal Investigator: Anne E McCarthy, MD, MSc         
Sub-Investigator: Charde A Morgan, MScPH         
International Association for Medical Assistance to Travellers Recruiting
Toronto, Ontario, Canada, M6K 3E3
Contact: Tullia Marcolongo    416-652-0137    tullia@iamat.org   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Anne E McCarthy, MD, MSc The Ottawa Hospital Research Institute
Study Chair: Catherine Ivory, PhD University of Ottawa, Faculty of Medicine
Study Chair: Louise Balfour, PhD Ottawa Hospital Research Institute
Study Chair: Charde A Morgan, MScPH Ottawa Hospital Research Institute

Additional Information:
Publications:
Chiodini PL, Field VK, Hill DR, Whitty CJM and Lalloo DG. Guidelines for malaria prevention in travellers from the United Kingdom. London, Public Health England, July 2013.

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01976325    
Other Study ID Numbers: 2010462-01H
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by Ottawa Hospital Research Institute:
decision aid
imported malaria
malaria prevention and control
malaria chemoprophylaxis
mefloquine
lariam
atovaquone-proguanil
malarone
doxycycline
vibramycin
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases