ISRCTN14298840已完成未知
The Big Sip. Can we improve thickened fluids for people with swallowing problems: an investigation into the gastrointestinal tolerance, acceptability, compliance and patient preference to Precise ThickN INSTANT thickener
Trisco Foods Pty Ltd0 个研究点目标入组 29 人开始时间: 2022年12月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years old and above
- •2. Already taking adequate amounts of thickened fluids as determined by the Speech and Language Therapist
- •3. Currently using a xanthan gum-based thickener that has been Advisory Committee on Borderline Substances (ACBS) approved
- •4. Expected to require thickened fluids for at least 4 more weeks from the point of recruitment
- •5. Already using xanthan gum thickener at a prescribed identified IDDSI level with no reported gastrointestinal difficulties
- •6. Able to give written consent or witnessed verbal consent if unable to write
- •7. Mild acquired communication difficulties who understand 3+ information-carrying words as determined by the Consent Support Tool CST
- •8. Participants with the cognitive ability to engage meaningfully in conversation and who can access and retain the study information and consent
排除标准
- •1. Not requiring thickened fluids. Specifically, who have not been prescribed thickened fluids by a qualified health practitioner after an oropharyngeal dysphagia diagnosis for acute or chronic swallowing difficulties
- •2. Requiring enteral tube feeding or parenteral nutrition, including patients who require top-up enteral feeding alongside the oral intake
- •3. Medical or dietary contraindications to any of the ingredients of PTI
- •4. The high (>85%) fibre content in xanthan gum may cause gastrointestinal difficulties. Therefore, participants that are currently using starch-based thickeners that do not contain fibre will be excluded
- •5. To avoid potentially adverse effects, participants with inflammatory bowel disease or previous bowel resection will be excluded due to the high (greater than 85%) fibre content of xanthan gum which can cause gastrointestinal irritation
- •6. Enrolled in any other studies concomitantly or within a month prior to entry into this study
- •7. The investigator has concerns regarding the ability or willingness of the patient and/or care provider to comply with protocol requirements
- •8. Currently using a pre-thickened beverage or have used PTI already
- •9. Using a powdered thickener that is not Advisory Committee on Borderline Substances (ACBS) approved
- •10. Significant cognitive difficulties
- •11. Acquired communication difficulty will be excluded if they present with significant visual and /or hearing difficulties, and have less than 3 keyword understanding, as these difficulties will have an impact on the completion of the survey
研究者
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