Clinical trial NCT04187859: Prompting And encouRaging Community Hydration Through EDucation
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Keywords: Hydration
Fluid Intake
Frailty
Feasibility Study
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: PRIME Centre Wales
First posted: 2019-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment of participants
timeFrame: 12 Weeks
measure: Retention of participants
timeFrame: 12 Weeks
measure: Retention of District Nurses
timeFrame: 12 Weeks
measure: Acceptability and practicality of intervention for participants
timeFrame: 12 Weeks
measure: Data Collection
timeFrame: 12 weeks
Secondary outcomes:
measure: Hydration risk score (G, U and L of the GULP tool)
timeFrame: 12 weeks
measure: Tilburg Frailty Indicator Questionnaire
timeFrame: 12 weeks
measure: Fluid and food frequency questionnaires
timeFrame: 12 weeks
measure: Fluid and food frequency questionnaires
timeFrame: 12 weeks
measure: Hydration self-efficacy Questionnaire
timeFrame: 12 weeks
measure: Quality of life Questionnaire
timeFrame: 12 weeks
measure: PANAS mood questionnaire
timeFrame: 12 weeks
measure: Montreal cognitive assessment
timeFrame: 12 weeks
measure: Semi-structured longitudinal interviews with District Nurses
timeFrame: 12 weeks
measure: Long-term follow up by NHS databases
timeFrame: 12 months
measure: Healthcare cost questionnaire
timeFrame: 12 weeks
measure: Evaluation Questionnaire
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Cwm Taf Morgannwg University Health Board
Study officials:
affiliation: Cwm Taf Morgannwg University Health Board
name: Rhian Beynon
role: STUDY_DIRECTOR
References: