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临床试验/NCT01976325
NCT01976325Unknown不适用

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

Ottawa Hospital Research Institute6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
6
主要终点
Travellers' Knowledge Score

研究概览

简要总结

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.

详细描述

RECRUITMENT

The participants will be recruited from the travel medicine clinic at The Ottawa Hospital General Campus, the National Capital Region Occupational Health Clinic, and through The International Association for Medical Assistance to Travellers (IAMAT), a non-profit organization dedicated to travel health. The study will undergo a recruitment process that is estimated to last for approximately one year, or until at least 100 patients complete all three questionnaires.

Recruitment begins at the time of initial contact with the travel clinic or IAMAT. Travelers routinely phone, email or fax the travel clinic to book their pre-travel consultation and the clerk at the clinic records pertinent information.

Recruitment at The Ottawa Hospital - General Campus Recruitment begins at the time of initial contact with the travel clinic. Travellers routinely phone the travel clinic to book their pre-travel consultation and the clerk at the clinic records pertinent information. At the time of booking, the clerk fills out a "Traveller Information Form", which contains an individual's name and contact information, lists the dates they will travel, and the countries that they plan to travel to. All travelers will be asked by the clerk if they would agree to be contacted by a researcher for a study. If they say yes, and the countries listed on the form are in line with those chosen for recruiting participants, the research assistant will contact them by the email or telephone number listed. The research assistant will send/read an email/telephone script which introduces the study and will ask participants if they would be interested in learning more. If they say yes, they will be provided with the study website information (a small paragraph describing the study with a link to study registration). Because the investigators recognize the difficulty of writing down website addresses, the traveller will have the option to provide the research assistant with their email address, if the research assistant does not have it already, and have the study website address sent to them electronically by the research assistant. The research assistant will not retain any personal information for any clients contacted at any time in the recruitment stage. The only information collected during recruitment will be the net number of clients called/emailed, and the net number who indicated that they would be interested in participating.

Recruitment at the National Capital Region Clinic Recruitment begins at the time of initial contact with the travel clinic. Travellers routinely email the travel clinic. Then they are sent a form to complete and email or fax. For all travellers planning to visit an area with chloroquine-resistant malaria for one year or less, the clerk will send an email attachment of the study recruitment information, including the study website information. No personal information about the individuals contacted will be collected by the study team. The clerk only will relay the net number of individuals contacted to the study research assistant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Travellers' Knowledge Score

时间窗: 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.

次要结局

  • Decisional Conflict Score(One year)
  • Preparation for Decision-making Score(One year)
  • Medication Adherence Score(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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