Dysphagia Cups in Elderly and Rehabilitation Setting

NCT05818501 | Completed

• 1 other identifier: Care food_protocol_v2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 6

Brief Summary

The study has 6 research questions regarding the use of dysphagia cups: Primary study questions:

1. 1.Can the use of the dysphagia cups increase water consumption and liquid consumption during the trial period?
2. 2.Can the use of the dysphagia cups reduce the frequency and intensity of choking and coughing while drinking?
3. 3.What are the potential risks to the service users while using the dysphagia cups?
4. 4.Can the use of the dysphagia cups enhance the autonomy of the service users in drinking?
5. 5.Can the use of the dysphagia cups reduce the amount of thickener used for water consumption?
6. 6.What are the perceived benefits and acceptability of using the dysphagia cups?

Conditions

Technology

Keywords

Gerontechnology; Risk; Water consumption; Autonomy

Outcome Measures

Primary Outcomes (5)

• Change of daily water consumption before and after using the dysphagia cup for 5 days

  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.

  From the start of 5-day pre-test to the end of 5-day trial period

• Change of daily actual liquid consumption in using conventional cup and dysphagia cup

  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.

  From the start of 5-day pre-test to the end of 5-day trial period

• Change of frequency of choking and coughing every day before and after using the dysphagia cup

  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.

  From the start of 5-day pre-test to the end of 5-day trial period

• Change of intensity of choking and coughing every day before and after using the dysphagia cup

  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.

  From the start of 5-day pre-test to the end of 5-day trial period

• Qualitative measures: Potential risks to service users while using the dysphagia cups

  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.

  From the start to the end of 2- or 3-day training period

Secondary Outcomes (4)

• 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

• Qualitative measures: The perceived benefits and acceptability of the dysphagia cups for caregivers

  At the end of the 5-day trial period

Study Arms (1)

The dysphagia cups

EXPERIMENTAL

The participants will use the one of the two models of dysphagia cups for 5 days during trial period.

Device: The dysphagia cups

Interventions

The dysphagia cups DEVICE

After the training period of the one of dysphagia cups, participants will start using cup to consume water during a designated period of time every day. Participants consuming water with Cup A will drink from a static position with their chins towards their chests, the so-called Chin-Tuck maneuver. This position leads epiglottal naturally covering the trachea and causes liquid only flowing to the esophagus and thus stomach. The restoring force of the membrane ensures a constant level of liquid at the upper edge of the cup and thus enables this preferred and safe drinking position. Cup B limits the maximum volume of water flowing out of the Cup B designated by the staff. Controlled liquid flow prevents overflowing the mouth and gulping, thus reduces the risk of choking and liquid aspiration. Participants can choose to drink the water from Cup B with a straw when necessary.

The dysphagia cups

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• \- Not able to learn to use Cup A during training session
• \- Not able to learn to use Cup B during training session
• \- None

Sponsors & Collaborators

• The University of Hong Kong: lead
• Haven of Hope Hospital: collaborator
• The Social Innovation and Entrepreneurship Development Fund, Hong Kong: collaborator

Study Sites (6)

Haven of Hope Hang Hau Care and Attention Home for Severely Disabled

Hong Kong, 00, Hong Kong

Location

Haven of Hope Ming Tak Day Activity Centre cum Hostel - Extended Care Programme

Hong Kong, 00, Hong Kong

Location

Haven of Hope Sister Annie Skau Holistic Care Centre

Hong Kong, 00, Hong Kong

Location

Haven of Hope Tsui Lam Day Care Centre for the Elderly

Hong Kong, 00, Hong Kong

Location

Haven of Hope Woo Ping Care & Attention Home

Hong Kong, 00, Hong Kong

Location

Haven of Hope Yee Ming Day Care Centre for the Elderly

Hong Kong, 00, Hong Kong

Location

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: The trial is a single group pre-post test study at elderly residential settings and rehabilitation settings. 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, and use the dysphagia cups for 5 days.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: July 13, 2023
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for 10 years.

Locations

HK (6)