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

Study Overview
=================
Brief 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

Official Title
-----------------
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

Conditions
-----------------
Melioidosis

Intervention / Treatment
-----------------
* Other: An educational programme for prevention of melioidosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female (Include pregnant women) , aged from 18 to 65 years old Diagnosed of diabetes according to American Diabetes Association 2013 as following Fasting plasma glucose (FPG) ≥ 126 mg/dl or HbA1C ≥ 6.5% or 2 hour plasma glucose (PG) ≥ 200 mg/dl during an OGTT or Classic symptoms of hyperglycaemia with a random PG ≥ 200 mg/dl Oriented and conversed normally Willingness to participate in the study, and written, informed consent obtained from patient Exclusion Criteria: Confused or unable to communicate Diagnosed of melioidosis and has not completed oral-eradicative treatment for melioidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cluster A<br>General education for prevention of diabetic complications in year 1, Melioidosis prevention education in years 2, 3 and 4. | Other: An educational programme for prevention of melioidosis<br>* 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.<br>|
| Other: Cluster B<br>General education for prevention of diabetic complications in year 1 and 2, Melioidosis prevention education in year 3 and 4. | Other: An educational programme for prevention of melioidosis<br>* 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.<br>|
| Other: Cluster C<br>General education for prevention of diabetic complications in year 1, 2 and 3, Melioidosis prevention education in year 4. | Other: An educational programme for prevention of melioidosis<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall hospital admissions due to infectious diseases | Infectious diseases will be determined by International Classification of Disease 10 (ICD10) defined by attending physicians. | Up to 4 years | 
| Culture-confirmed melioidosis | Culture-confirmed melioidosis is defined as presentation with clinical features of melioidosis in association with cultures from any clinical specimen positive for Burkholderia pseudomallei. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Overall mortality is defined as death from all causes. | Up to 4 years | 
| Overall melioidosis | Overall melioidosis is defined as a combination of culture confirmed melioidosis and clinical melioidosis. Clinical melioidosis is defined as presentation with clinical features of melioidosis in association with cultures from all clinical specimens negative for Burkholderia pseudomallei. | Up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Melioidosis, stepped wedge trial, behaviour change, Education program