The Effectiveness and Feasibility of Dysphagia Cups in Elderly and Rehabilitation Setting: A Single Group Pre-post Test Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 12
- 主要终点
- Change of frequency of choking and coughing every day before and after using the dysphagia cup
研究概览
简要总结
The study has 6 research questions regarding the use of dysphagia cups:
Primary study questions:
- Can the use of the dysphagia cups increase water consumption and liquid consumption during the trial period?
- Can the use of the dysphagia cups reduce the frequency and intensity of choking and coughing while drinking?
- What are the potential risks to the service users while using the dysphagia cups?
Secondary study question: 4. Can the use of the dysphagia cups enhance the autonomy of the service users in drinking?
Auxiliary study questions: 5. Can the use of the dysphagia cups reduce the amount of thickener used for water consumption? 6. What are the perceived benefits and acceptability of using the dysphagia cups?
详细描述
Study design
The trial is a single group pre-post test study. During the 12-day or 13-day trial period, the participants will use conventional cups in the first 5 days of the trial, receive 2-3 days of training on using the one of the two models of dysphagia cups (Cup A and Cup B), and use the dysphagia cups for 5 days.
This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP).
Procedures
- Staff training
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for service users using Cup A:
- •Is recommended to consume liquid at the International Dysphagia Diet Standardisation Initiative (IDDSI) level 1 or 2, by the speech therapist, occupational therapist or nurse of the study site,
- •Able to perform chin-down posture when swallowing,
- •Able to hold Cup A with single hand or both hands, and
- •Able to understand Chinese
- •Inclusion criteria for service users using Cup B:
- •Is recommended to consume liquid at the International Dysphagia Diet Standardisation Initiative (IDDSI) level 1 or 2, by the speech therapist, occupational therapist or nurse of the study site,
- •Able to hold Cup B with single hand or both hands, or drinking water using straws, and
- •Able to understand Chinese
- •Inclusion criteria for staff:
- •Responsible for helping participants to drink water using conventional cups (i.e. occupational therapist, speech therapist, nurse and care staff), and
- •Able to understand Chinese
排除标准
- •Exclusion criteria for service users using Cup A:
- •Not able to learn to use Cup A during training session
- •Exclusion criteria for service users using Cup B:
- •Not able to learn to use Cup B during training session
- •Exclusion criteria for staff:
结局指标
主要结局
Change of frequency of choking and coughing every day before and after using the dysphagia cup
时间窗: From the start of 5-day pre-test to the end of 5-day trial period
Change of frequency of choking and coughing while drinking in using the conventional cup for 5-day pre-test and the dysphagia cup for 5-day trial period will be counted and recorded by the care staff every day.
Change of daily water consumption before and after using the dysphagia cup for 5 days
时间窗: From the start of 5-day pre-test to the end of 5-day trial period
Change of water consumption (including all sugar- and oil-free fluid) of each participant at the designated time in using the conventional cup for 5-day pre-test and the dysphagia cups for 5-day trial period will be recorded by the care staff every day. The volume value is expressed in the unit of milliliter.
Change of daily actual liquid consumption in using conventional cup and dysphagia cup
时间窗: From the start of 5-day pre-test to the end of 5-day trial period
Change of actual liquid consumption (including water consumption using both dysphagia cups and conventional cups and other liquid consumption, e.g. soup, milk and juice) of each participant will be recorded by the care staff every day from the pre-test period to the formal trial period. The volume value is expressed in unit of milliliter.
Change of intensity of choking and coughing every day before and after using the dysphagia cup
时间窗: From the start of 5-day pre-test to the end of 5-day trial period
Change of intensity of choking and coughing while drinking in using the conventional cup for 5-day pre-test and the dysphagia cup for 5-day trial period will be observed and recorded by the care staff every day. Care staff will complete an item and the minimum and maximum values of scale is 0 and 2 respectively, with higher score indicating more choking and coughing while drinking.
Qualitative measures: Potential risks to service users while using the dysphagia cups
时间窗: From the start to the end of 2- or 3-day training period
During the training of each dysphagia cup, the responsible clinical staff will observe the selected training session(s) for potential risks and produce the findings in an observation report. The contents include resembling the cups, pouring water into the cups and positioning the cups.
次要结局
- Qualitative measures: The perceived benefits and acceptability of the dysphagia cups for caregivers(At the end of the 5-day trial period)
- Change of autonomy of service users in drinking before and after using the dysphagia cup(From the start of 5-day pre-test to the end of 5-day trial period)
- Change of the amount of thickener used for water consumption before and after using the dysphagia cup(From the start of 5-day pre-test to the end of 5-day trial period)
- Qualitative measures: The perceived benefits and acceptability of the dysphagia cups for participants(At the end of the 5-day trial period)
研究者
Dr. Derek Yee-Tak Cheung
Principal Investigator, Assistant Professor
The University of Hong Kong