Acceptability and feasibility of Jelly Drops™ in people with dementia
| ISRCTN | ISRCTN16279118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16279118 |
| Integrated Research Application System (IRAS) | 357387 |
| Central Portfolio Management System (CPMS) | 70823 |
| Sponsor | Rotherham Doncaster and South Humber NHS Foundation Trust |
| Funder | Jelly Drops Ltd |
- Submission date
- 17/06/2026
- Registration date
- 17/08/2026
- Last edited
- 17/08/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Issues with water balance in the body and dehydration prevail in those with dementia. This is associated with an increased likelihood for hospitalisation and a reduced quality of life for those affected. In dementia the sensation of thirst can become affected, and putting a drink in front of someone may not be an adequate prompt to enable them to drink. Part of effective dementia care is ensuring that people with dementia remain adequately hydrated. The burden to support hydration falls on carers (paid and unpaid) by prompting and setting reminders; however, this is not always effective. There is an added issue of a lack of valid predictors for dehydration in those with dementia; therefore, the need to find strategies to boost hydration is hugely important for this population. This acceptability and feasibility study is proposed to explore the feasibility of a novel confectionary, Jelly Drops™, which was specifically designed to support hydration in those with dementia.
Who can participate?
Participants for the study will be residing in England and will be recruited purposively via Rotherham, Doncaster and South Humber (RDaSH) NHS Foundation Trust’s clinical services. This study is assessing the feasibility of providing Jelly Drops™ to patients on an inpatient ward treating older adults with dementia or other mental health issues. The population from which the study sample will be drawn are individuals who receive usual care within an NHS inpatient ward, where dehydration is a known issue.
Participants in the interview study will fall into three categories:
1. NHS patients who have capacity and who received Jelly Drops™
2. Familial carers or nominated professionals acting as consultees where participants do not have capacity
3. Healthcare professionals working with patients who received Jelly Drops™
What does the study involve?
Patients will be provided with Jelly Drops™ under the supervision of a member of the hospital team and will be prescribed for use three to four times per day. Taking Jelly Drops ™ will not change any other treatment or care that the hospital will provide.
Someone from the hospital team will be monitoring the patient's health throughout their stay using tools like skin integrity tests, bowel and urine monitoring and food and fluid intake charts, which are used as part of routine care. These tests and monitoring tools will be used as required, but we anticipate this will be four times per day. These will help staff to see if the patient is dehydrated.
Data the hospital team collect related to patients’ health during the study may be used to check whether the Jelly Drops™ have helped them to get hydrated, for example, the results from routine blood tests.
Once the participant has consented, they will be offered Jelly Drops™ at different points while they are on the ward if the staff feel their hydration levels indicate dehydration or risk of dehydration.
Patients, carers and staff will be invited to take part in a one-off interview to speak about their experiences of Jelly Drops™.
What are the possible benefits and risks of participating?
Participants, family members and staff could gain a better understanding of whether (and how much) Jelly Drops ™ can help with dehydration. Participants and family members may find out that Jelly Drops ™ are an acceptable or more convenient means of hydration.
Participants consuming Jelly Drops™ will be residents on an inpatient ward. Any sensitive conversations will be carried out by a member of the healthcare team, who are trained and experienced at supporting patients with these sorts of discussion topics.
For interview participants a distress protocol will be in use, and staff conducting interviews will be experienced with managing sensitive topics. Interview participants will also be provided with a debrief sheet following the interview which thanks them for their participation and advises them of local support services they can contact if they feel they need further support.
Where is the study run from?
Rotherham Doncaster and South Humber NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2026 to September 2027
Who is funding the study?
Jelly Drops™ Ltd (UK)
Who is the main contact?
Dr Kevin Williamson, kevin.williamson@nhs.net
Contact information
Principal investigator, Scientific
Rotherham Doncaster and South Humber NHS Foundation Trust, Grounded Research, 2 St Catherine’s Close, Tickhill Rd Hospital Site
Doncaster
DN4 8QN
United Kingdom
| Phone | +44 (0)3000 212456 |
|---|---|
| kevin.williamson@nhs.net |
Public
Grounded Research, Rotherham Doncaster and South Humber NHS Foundation Trust, 2 St Catherine’s Close, Tickhill Rd Hospital Site
Doncaster
DN4 8QN
United Kingdom
| Phone | +44 (0)3000 212456 |
|---|---|
| rdash.research-gov@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized study |
| Secondary study design | Non randomised study |
| Participant information sheet | 49732_PIS_V1.2_15Apr2026.pdf |
| Scientific title | AQUA: an open-label Acceptability and feasibility trial of ‘Jelly Drops™’ for hydration and QUAlity of care for people with dementia |
| Study acronym | AQUA |
| Study objectives | The aim of this study is to see whether a) Jelly Drops™ is an acceptable intervention to patients and their families as a means to support hydration and b) it is feasible to collect all the data needed to properly test the intervention as a means of hydration in a future randomised controlled trial |
| Ethics approval(s) |
Approved 21/04/2026, Welsh Research Ethics Committee 1 (Health and Care Research Wales Floor 4, Crown Building, Cathays Park, Cardiff, CF10 3NQ, United Kingdom; -; Wales.REC1@wales.nhs.uk), ref: 26/WA/0046 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Participant identification: Healthcare professionals in the clinical team will receive 60 minutes of training on the study protocol and other documents from members of the research team in order to recruit to the study. A nurse consultant will help to identify patients that might be suitable for the current study. Someone from the hospital team will speak to the patient or their family member to ask if they are interested in taking part in the study. Participant approach: Potential participants and/or family members will be given more information about the study through the Participant Information Sheet (PIS) and given the chance to ask the research team any questions. Participant screening: The research team will perform screening against eligibility criteria to see if participants are suitable to take part in the study. The research team will be available to answer any questions if needed. Provide consent: Once happy with the study information, potential participants and/or family members will be asked to provide consent by completing a form. Baseline: Once consented, the participant will undergo a number of baseline procedures which are all part of usual care. These will be a blood test, fluid and bowel charts, a skin integrity test and diet monitoring. Provision of Jelly Drops™: These will be given to the participant by a member of the hospital team. Taking Jelly Drops ™ will not change any other treatment or care that the hospital will provide for the participant and will be given additionally to usual care. Consumption will then be monitored by staff on wards. Open Jelly Drops™ will be swapped for fresh ones if not consumed within a set period of time and as they are monitored we will be aware of whether any Jelly Drops™ have been left in participant bedrooms, given away or otherwise disposed of by participants. Measuring participants' hydration and nutrition: Someone from the hospital team will be monitoring the participant’s health throughout the study. This will include whether they are dehydrated using skin integrity tests, fluid balance and bowel charts, and diet monitoring which will be completed multiple times a day, every day throughout the study, as is done in routine care. Interviews: A member of the team will also ask participants, i.e., patients who are able to consent, familial carers and healthcare staff, if they wish to take part in a one-to-one interview where they will be asked about their experience of the process of being prescribed the Jelly Drops ™ and their quality of life after taking the Jelly Drops™. This will require consent again, and information will be provided to the participant about what this will involve beforehand. Data analysis: Data the hospital team collect related to the participant’s health during the study will be used to check for trends across the study. We will not have enough data at this stage to measure the effectiveness of Jelly Drops™. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Hydration and renal function measured using clinical blood sample at baseline (day 0) |
| Completion date | 30/09/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 25 |
| Key inclusion criteria | 1. Aged 16 years or older (inclusive) on the day of consent (for carers and consentees) 2. Either: 2.1. A diagnosis of dementia and be undergoing NHS care 2.2. A family member who has received a diagnosis of and is being treated for, dementia 2.3. A healthcare professional providing care for those with dementia |
| Key exclusion criteria | 1. Inability to read and understand the consent form in order to provide informed consent to participate in the study. (with the exception of participants who have an appropriate consultee or those for whom translation or interpreter adaptations are available as would be used in usual care) 2. Patient with known swallowing difficulties 3. Patients may be excluded if there is a medication or safety issue identified by the clinical team or due to the potential burden of sample collection |
| Date of first enrolment | 27/03/2026 |
| Date of final enrolment | 31/08/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Tickhill Road
Doncaster
DN4 8QN
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the chief investigator. This is a feasibility study, so the data set is limited to the measures set out under the outcome measures. Requests should be sent to Dr Kevin Williamson (kevin.williamson@nhs.net). Data will be available after the end of the trial when the study has been analysed and written up. Data will be stored for 10 years after the end of the trial. Reasonable requests will be considered; no identifiable data will be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 15/04/2026 | 14/07/2026 | No | Yes |
| Protocol file | version 1.1 | 20/03/2026 | 14/07/2026 | No | No |
Additional files
- 49732_PIS_V1.2_15Apr2026.pdf
- Participant information sheet
- 49732_Protocol_V1.1_20Mar2026.pdf
- Protocol file
Editorial Notes
17/06/2026: Study's existence confirmed by the NIHR.
