Prompting And encouRaging Community Hydration Through EDucation (PARCHED)

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.

Study Overview

• Status: Unknown
• Conditions: Frailty
• Intervention / Treatment: Behavioral: Education Session; Device: Prompting Cup

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merthyr Tydfil, United Kingdom
    • Recruiting
    • Cwm Taf Morgannwg University Health Board
    • Contact: Claire Nott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Education Session; 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.	Behavioral: Education Session; Participants will receive an education session from their District Nurse, advising on how to improve their hydration.
Other: Prompting Cup; 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.	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
No Intervention: Control Group; There will be no change to the care the participant receives from the District Nurse.
Other: Prompting Cup and Education; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of participants		12 Weeks
Retention of participants		12 Weeks
Retention of District Nurses		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.	12 Weeks
Data Collection	Completion of Case Report Forms	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydration risk score (G, U and L of the GULP tool)		12 weeks
Tilburg Frailty Indicator Questionnaire		12 weeks
Fluid and food frequency questionnaires	BEV-15	12 weeks
Fluid and food frequency questionnaires	SSFFQ	12 weeks
Hydration self-efficacy Questionnaire		12 weeks
Quality of life Questionnaire	EQ5D	12 weeks
PANAS mood questionnaire		12 weeks
Montreal cognitive assessment		12 weeks
Semi-structured longitudinal interviews with District Nurses		12 weeks
Long-term follow up by NHS databases		12 months
Healthcare cost questionnaire		12 weeks
Evaluation Questionnaire		12 Weeks

Collaborators and Investigators

• Sponsor: Cwm Taf University Health Board (NHS)
• Collaborators: PRIME Centre Wales
• Investigators: Study Director: Rhian Beynon, Cwm Taf Morgannwg University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hydration; Frailty; Feasibility Study; Fluid Intake
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 257723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No