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

NCT02089152 | Completed

• 1 other identifier: MICRO1307
• Study Type: interventional
• Target: 9,075
• Locations: 1 country
• Sites: 1

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.

Conditions

Melioidosis

Keywords

Diabetes; Melioidosis; stepped wedge trial; behaviour change; Education program

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall mortality

  Up to 4 years

• Overall melioidosis

  Up to 4 years

Study Arms (3)

Cluster A

OTHER

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

Cluster B

OTHER

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

Cluster C

OTHER

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

Interventions

An educational programme for prevention of melioidosis OTHER

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.

Cluster A; Cluster B; Cluster C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Confused or unable to communicate
• Diagnosed of melioidosis and has not completed oral-eradicative treatment for melioidosis

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Sappasithiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

Related Publications (18)

• Limmathurotsakul D, Wongratanacheewin S, Teerawattanasook N, Wongsuvan G, Chaisuksant S, Chetchotisakd P, Chaowagul W, Day NP, Peacock SJ. Increasing incidence of human melioidosis in Northeast Thailand. Am J Trop Med Hyg. 2010 Jun;82(6):1113-7. doi: 10.4269/ajtmh.2010.10-0038.

  PMID: 20519609 BACKGROUND

• Limmathurotsakul D, Peacock SJ. Melioidosis: a clinical overview. Br Med Bull. 2011;99:125-39. doi: 10.1093/bmb/ldr007. Epub 2011 May 9.

  PMID: 21558159 BACKGROUND

• Currie BJ, Dance DA, Cheng AC. The global distribution of Burkholderia pseudomallei and melioidosis: an update. Trans R Soc Trop Med Hyg. 2008 Dec;102 Suppl 1:S1-4. doi: 10.1016/S0035-9203(08)70002-6.

  PMID: 19121666 BACKGROUND

• Limmathurotsakul D, Dance DA, Wuthiekanun V, Kaestli M, Mayo M, Warner J, Wagner DM, Tuanyok A, Wertheim H, Yoke Cheng T, Mukhopadhyay C, Puthucheary S, Day NP, Steinmetz I, Currie BJ, Peacock SJ. Systematic review and consensus guidelines for environmental sampling of Burkholderia pseudomallei. PLoS Negl Trop Dis. 2013;7(3):e2105. doi: 10.1371/journal.pntd.0002105. Epub 2013 Mar 21.

  PMID: 23556010 BACKGROUND

• Suputtamongkol Y, Hall AJ, Dance DA, Chaowagul W, Rajchanuvong A, Smith MD, White NJ. The epidemiology of melioidosis in Ubon Ratchatani, northeast Thailand. Int J Epidemiol. 1994 Oct;23(5):1082-90. doi: 10.1093/ije/23.5.1082.

  PMID: 7860160 BACKGROUND

• Faa AG, Holt PJ. Melioidosis in the Torres Strait islands of far North Queensland. Commun Dis Intell Q Rep. 2002;26(2):279-83. doi: 10.33321/cdi.2002.26.26.

  PMID: 12206383 BACKGROUND

• Limmathurotsakul D, Kanoksil M, Wuthiekanun V, Kitphati R, deStavola B, Day NP, Peacock SJ. Activities of daily living associated with acquisition of melioidosis in northeast Thailand: a matched case-control study. PLoS Negl Trop Dis. 2013;7(2):e2072. doi: 10.1371/journal.pntd.0002072. Epub 2013 Feb 21.

  PMID: 23437412 BACKGROUND

• Limmathurotsakul D, Wongsuvan G, Aanensen D, Ngamwilai S, Saiprom N, Rongkard P, Thaipadungpanit J, Kanoksil M, Chantratita N, Day NP, Peacock SJ. Melioidosis caused by Burkholderia pseudomallei in drinking water, Thailand, 2012. Emerg Infect Dis. 2014 Feb;20(2):265-8. doi: 10.3201/eid2002.121891.

  PMID: 24447771 BACKGROUND

• Wongsuvan N, Malasit M, Hongsuwan M, et al. Defining beliefs and environmental contraints on prevention of melioidosis in northeast Thailand. 2013. (manuscript under preparation)

  BACKGROUND

• Limmathurosakul D, Lubell Y, Day N, Peacock N. Modelling the cost-effectiveness of strategies to prevent melioidosis in northeast Thailand. 2013. (manuscript under preparation)

  BACKGROUND

• Chaowagul W, White NJ, Dance DA, Wattanagoon Y, Naigowit P, Davis TM, Looareesuwan S, Pitakwatchara N. Melioidosis: a major cause of community-acquired septicemia in northeastern Thailand. J Infect Dis. 1989 May;159(5):890-9. doi: 10.1093/infdis/159.5.890.

  PMID: 2708842 BACKGROUND

• Leelarasamee A, Bovornkitti S. Melioidosis: review and update. Rev Infect Dis. 1989 May-Jun;11(3):413-25. doi: 10.1093/clinids/11.3.413.

  PMID: 2665001 BACKGROUND

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  PMID: 23512568 BACKGROUND

• Cheng AC, Currie BJ, Dance DAB, Funnell SGP, Limmathurotsakul D, Simpson AJH, Peacock SJ. Clinical definitions of melioidosis. Am J Trop Med Hyg. 2013 Mar;88(3):411-413. doi: 10.4269/ajtmh.12-0555.

  PMID: 23468355 BACKGROUND

• Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, King B, Chaisson RE. Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Clin Trials. 2007;4(2):190-9. doi: 10.1177/1740774507076937.

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• Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.

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• Bursac Z, Gauss CH, Williams DK, Hosmer DW. Purposeful selection of variables in logistic regression. Source Code Biol Med. 2008 Dec 16;3:17. doi: 10.1186/1751-0473-3-17.

  PMID: 19087314 BACKGROUND

• Suntornsut P, Teparrukkul P, Wongsuvan G, Chaowagul W, Michie S, Day NPJ, Limmathurotsakul D. Effectiveness of a multifaceted prevention programme for melioidosis in diabetics (PREMEL): A stepped-wedge cluster-randomised controlled trial. PLoS Negl Trop Dis. 2021 Jun 25;15(6):e0009060. doi: 10.1371/journal.pntd.0009060. eCollection 2021 Jun.

  PMID: 34170931 DERIVED

MeSH Terms

Conditions

Melioidosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Burkholderia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Assist Prof. Direk Limmathurotsakul, M.D.

  Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: April 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: July 21, 2021

Record last verified: 2019-09

Locations

TH (1)