Prompting And encouRaging Community Hydration Through EDucation

Frailty Clinical Trial

— PARCHED  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187859
• Other study ID #: 257723
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: May 2021

Study information

• Verified date: October 2019
• Source: Cwm Taf University Health Board (NHS)
• Contact: Christina Lloydwin, PhD
• Phone: 01685 351456
• Email: christina.lloydwin[@]wales.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Education Session
Participants will receive an education session from their District Nurse, advising on how to improve their hydration.

Device:
• Prompting Cup
The Droplet Cup is an electronic prompting cup that emits a sound and/or light to encourage the participant to take a drink

Locations

Country	Name	City	State
United Kingdom	Cwm Taf Morgannwg University Health Board	Merthyr Tydfil

Sponsors (2)

Lead Sponsor	Collaborator
Cwm Taf University Health Board (NHS)	PRIME Centre Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of participants		12 Weeks
Primary	Retention of participants		12 Weeks
Primary	Retention of District Nurses		12 Weeks
Primary	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.	12 Weeks
Primary	Data Collection	Completion of Case Report Forms	12 weeks
Secondary	Hydration risk score (G, U and L of the GULP tool)		12 weeks
Secondary	Tilburg Frailty Indicator Questionnaire		12 weeks
Secondary	Fluid and food frequency questionnaires	BEV-15	12 weeks
Secondary	Fluid and food frequency questionnaires	SSFFQ	12 weeks
Secondary	Hydration self-efficacy Questionnaire		12 weeks
Secondary	Quality of life Questionnaire	EQ5D	12 weeks
Secondary	PANAS mood questionnaire		12 weeks
Secondary	Montreal cognitive assessment		12 weeks
Secondary	Semi-structured longitudinal interviews with District Nurses		12 weeks
Secondary	Long-term follow up by NHS databases		12 months
Secondary	Healthcare cost questionnaire		12 weeks
Secondary	Evaluation Questionnaire		12 Weeks