FrailtyPARCHEDNCT04187859
Prompting And encouRaging Community Hydration Through EDucation
A study testing Education Session and Prompting Cup in people with Frailty, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
Trial summary
PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Education Session and Prompting Cup
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PARCHED will recruit district nurse patients at medium or high risk of dehydration (using the G, U and L of the GULP tool1),
- with a urinary catheter,
- living at home in community or residential care,
- aged 18 years or above
Who cannot join
- Inability to provide informed consent,
- medical conditions or dietary restrictions that would substantially limit ability to complete study requirements (i.e. intravenous fluid intake, inability to lift cup),
- living in nursing care setting,
- end of life pathway,
- diagnosed swallowing difficulty,
- inability to communicate in English or Welsh.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cwm Taf Morgannwg University Health Board
Merthyr Tydfil
Claire Nott
About this study
Official title: A Feasibility Cluster RCT Investigating Improving Fluid Intake in Community-dwelling Urinary Catheterised District Nurse Patients Using an Innovative Prompting Cup, Education or a Combination of These Interventions.
PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty.
PARCHED will randomise four areas in Cwm Taf University Health Board to receive one of four different interventions. Individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.
Read the detailed description
PARCHED is a cluster feasibility randomized control trial (RCT) exploring the potential of an innovative prompting cup and education as person-centred and holistic tools to empower nursing leadership to reduce frailty in a catheterised community-dwelling population. This project will investigate interventions to improve hydration as potentially economically viable solutions to reducing frailty in a vulnerable population. Interventions have been developed using behaviour change theory and techniques. 80 participants will be recruited and will receive one of three interventions or usual care for a period of 12 weeks, data will be collected at baseline, 4 weeks and 12 weeks. Questionnaires, semi-structured interviews, and routine hospital records will be collected or accessed as part of the study.
- Conditions
- Frailty
- Being tested
- Education Session, Prompting Cup
- Keywords
- Hydration, Fluid Intake, Frailty, Feasibility Study
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education SessionBehavioural
Participants will receive an education session from their District Nurse, advising on how to improve their hydration.
Prompting CupDevice
The Droplet Cup is an electronic prompting cup that emits a sound and/or light to encourage the participant to take a drink
| Study group | Role | What they receive |
|---|---|---|
| Education Session | Other | The participant will receive an education session in their home, lasting between 15-30 minutes from a District Nurse. The District Nurses will advise the participant on how to drink more fluids, the importance of hydration and the effects of dehydration. Receives: Behavioral: Education Session |
| Prompting Cup | Other | Participants will receive a Droplet Cup with an electronic prompting device and a brief tutorial session from the District Nurse. The Droplet Cup will encourage the participant to stay hydrated during the day, by emitting a voice or light to encourage them to drink more. Receives: Device: Prompting Cup |
| Control Group | No intervention | There will be no change to the care the participant receives from the District Nurse. |
| Prompting Cup and Education | Other | Participants will receive a Droplet Cup with an electronic prompting device and an education session on the importance of hydration and the effects of dehydration. Receives: Behavioral: Education Session; Device: Prompting Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of participants
Measured: 12 Weeks
Retention of participants
Measured: 12 Weeks
Retention of District Nurses
Measured: 12 Weeks
Acceptability and practicality of intervention for participants
Participants will be approached to complete semi structured interviews which will explore the mechanisms and outcomes of the interventions.
Measured: 12 Weeks
Data Collection
Completion of Case Report Forms
Measured: 12 weeks
Secondary outcomes (12)
Hydration risk score (G, U and L of the GULP tool)
Measured: 12 weeks
Tilburg Frailty Indicator Questionnaire
Measured: 12 weeks
Fluid and food frequency questionnaires
BEV-15
Measured: 12 weeks
Fluid and food frequency questionnaires
SSFFQ
Measured: 12 weeks
Hydration self-efficacy Questionnaire
Measured: 12 weeks
Quality of life Questionnaire
EQ5D
Measured: 12 weeks
PANAS mood questionnaire
Measured: 12 weeks
Montreal cognitive assessment
Measured: 12 weeks
Semi-structured longitudinal interviews with District Nurses
Measured: 12 weeks
Long-term follow up by NHS databases
Measured: 12 months
Healthcare cost questionnaire
Measured: 12 weeks
Evaluation Questionnaire
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start6 Jan 2020
- Primary completionSep 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- PRIME Centre Wales
- Responsible party
- Sponsor
- Investigators
- Rhian Beynon, Study director, Cwm Taf Morgannwg University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187859
- Sponsor's protocol ID
- 257723
- Acronym
- PARCHED
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Cluster RCT Investigating Improving Fluid Intake in Community-dwelling Urinary Catheterised District Nurse Patients Using an Innovative Prompting Cup, Education or a Combination of These Interventions.
- ClinicalTrials.gov ID
- NCT04187859
- Acronym / sponsor ID
- PARCHED / 257723
- Conditions
- Frailty
- Keywords
- Hydration, Fluid Intake, Frailty, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- PRIME Centre Wales
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty.
PARCHED will randomise four areas in Cwm Taf University Health Board to receive one of four different interventions. Individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.
Detailed description
PARCHED is a cluster feasibility randomized control trial (RCT) exploring the potential of an innovative prompting cup and education as person-centred and holistic tools to empower nursing leadership to reduce frailty in a catheterised community-dwelling population. This project will investigate interventions to improve hydration as potentially economically viable solutions to reducing frailty in a vulnerable population. Interventions have been developed using behaviour change theory and techniques. 80 participants will be recruited and will receive one of three interventions or usual care for a period of 12 weeks, data will be collected at baseline, 4 weeks and 12 weeks. Questionnaires, semi-structured interviews, and routine hospital records will be collected or accessed as part of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Education Session | Other | Behavioral: Education SessionThe participant will receive an education session in their home, lasting between 15-30 minutes from a District Nurse. The District Nurses will advise the participant on how to drink more fluids, the importance of hydration and the effects of dehydration. |
| Prompting Cup | Other | Device: Prompting CupParticipants will receive a Droplet Cup with an electronic prompting device and a brief tutorial session from the District Nurse. The Droplet Cup will encourage the participant to stay hydrated during the day, by emitting a voice or light to encourage them to drink more. |
| Control Group | No intervention | –There will be no change to the care the participant receives from the District Nurse. |
| Prompting Cup and Education | Other | Behavioral: Education Session, Device: Prompting CupParticipants will receive a Droplet Cup with an electronic prompting device and an education session on the importance of hydration and the effects of dehydration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PARCHED will recruit district nurse patients at medium or high risk of dehydration (using the G, U and L of the GULP tool1),
- with a urinary catheter,
- living at home in community or residential care,
- aged 18 years or above
Key exclusion criteria (6 listed)
- Inability to provide informed consent,
- medical conditions or dietary restrictions that would substantially limit ability to complete study requirements (i.e. intravenous fluid intake, inability to lift cup),
- living in nursing care setting,
- end of life pathway,
- diagnosed swallowing difficulty,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education SessionParticipants will receive an education session from their District Nurse, advising on how to improve their hydration. | Behavioural | Education Session, Prompting Cup and Education |
| Prompting CupThe Droplet Cup is an electronic prompting cup that emits a sound and/or light to encourage the participant to take a drink | Device | Prompting Cup, Prompting Cup and Education |
Primary outcome
Recruitment of participants
Time frame: 12 Weeks
Retention of participants
Time frame: 12 Weeks
Retention of District Nurses
Time frame: 12 Weeks
Acceptability and practicality of intervention for participants
Time frame: 12 Weeks
Participants will be approached to complete semi structured interviews which will explore the mechanisms and outcomes of the interventions.
Data Collection
Time frame: 12 weeks
Completion of Case Report Forms
12 secondary outcomes
Hydration risk score (G, U and L of the GULP tool)
Time frame: 12 weeks
Tilburg Frailty Indicator Questionnaire
Time frame: 12 weeks
Fluid and food frequency questionnaires
Time frame: 12 weeks
Fluid and food frequency questionnaires
Time frame: 12 weeks
Hydration self-efficacy Questionnaire
Time frame: 12 weeks
Quality of life Questionnaire
Time frame: 12 weeks
PANAS mood questionnaire
Time frame: 12 weeks
Montreal cognitive assessment
Time frame: 12 weeks
Semi-structured longitudinal interviews with District Nurses
Time frame: 12 weeks
Long-term follow up by NHS databases
Time frame: 12 months
Healthcare cost questionnaire
Time frame: 12 weeks
Evaluation Questionnaire
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhian Beynon study director
Cwm Taf Morgannwg University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Session and Prompting Cup in people with Frailty, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Lloydwin, PhD (01685 351456, christina.lloydwin@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of participants (time frame: 12 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.