A Single-blind Stepped Wedge Cluster Randomized Controlled Behaviour Change Trial to Determine Effectiveness of Prevention Programme of Melioidosis in Diabetics in Ubon Ratchathani, Northeast Thailand
Condition: Melioidosis
MeSH terms: Melioidosis
Study type: Interventional

Summary: 
      Study hypothesis:

      Prevention programme for melioidosis can reduce incidences of overall hospitalization due to
      infectious diseases and due to culture-confirmed melioidosis in diabetic population in
      northeast Thailand

      This study is a prospective single-blind multicentre stepped wedge cluster randomized
      controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.
    

Detailed description: 
      Melioidosis is an infectious disease caused by soil-dwelling Gram-negative bacilli
      Burkholderia pseudomallei. The disease is highly endemic in northeast Thailand. Diabetes
      mellitus is the major underlying risk factor for melioidosis, occurring in more than 50% of
      all culture-proven melioidosis patients. The annual incidence of melioidosis in diabetes in
      northeast Thailand is currently 244 per 100,000, and the overall case fatality rate is about
      40%. The number of people dying from melioidosis is now comparable to deaths from
      tuberculosis, and exceeds those from malaria, diarrheal illnesses and measles combined.
      Melioidosis is potentially preventable since infection occurs as a direct result of exposure
      to B. pseudomallei in the environment. Nonetheless, most of Thai people have never heard of
      melioidosis, there is currently no vaccine for melioidosis, and formal prevention guideline
      are lacking worldwide.

      The investigators recently developed new guidelines for the prevention of melioidosis in
      Thailand; including avoidance of direct contact with soil or environmental water and use of
      protective gear if contact is necessary, consumption of bottled or boiled water only, and
      avoidance of direct contact with heavy rain and dust clouds.

      The investigators aim to conduct a clinical trial to determine effectiveness of the proposed
      prevention programme of melioidosis. The investigators also predict that the prevention
      programme of melioidosis will also prevent other common infectious diseases with have similar
      routes of infection, such as leptospirosis and acute diarrhea. The outcome of the RCT will be
      crucial evidence for the Ministry of Public Health (MoPH) Thailand for their consideration of
      policy changes for the prevention of melioidosis countrywide.

      The funder: Wellcome Trust. Grant reference number: 101103/Z/13/Z

      Result:

      Pubmed link: https://pubmed.ncbi.nlm.nih.gov/34170931/

      PLoS NTD link: https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0009060

      DOI: https://doi.org/10.1371/journal.pntd.0009060

      MedRxiv: https://www.medrxiv.org/content/10.1101/2020.12.18.20248448v1
    

Intervention name(s): An educational programme for prevention of melioidosis
Intervention type(s): Other
Intervention description(s): The intervention will be randomly implemented at 10, 10 and 10 diabetic clinics at the end of years 1, 2 and 3, respectively. The education will be conducted using small group education, in which 20 to 25 participants at a time will attend group sessions conducted by the study team.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Diabetes; Melioidosis; stepped wedge trial; behaviour change; Education program