Prompting And encouRaging Community Hydration Through EDucation

Not Applicable

• Conditions: Frailty
• Interventions: Device: Prompting Cup; Behavioral: Education Session

• Registration Number: NCT04187859
• Lead Sponsor: Cwm Taf University Health Board (NHS)

Brief 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.

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-01-06
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23
• Primary Completion: 2020-09
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prompting Cup	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.
Prompting Cup and Education	Education Session	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.
Education Session	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.
Prompting Cup and Education	Prompting Cup	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.

Primary Outcome Measures

Name	Time	Method
Retention of District Nurses	12 Weeks
Recruitment of participants	12 Weeks
Acceptability and practicality of intervention for participants	12 Weeks	Participants will be approached to complete semi structured interviews which will explore the mechanisms and outcomes of the interventions.
Retention of participants	12 Weeks
Data Collection	12 weeks	Completion of Case Report Forms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cwm Taf Morgannwg University Health Board; 🇬🇧 Merthyr Tydfil, United Kingdom