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Prompting And encouRaging Community Hydration Through EDucation (PARCHED)

Primary Purpose

Frailty

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Education Session
Prompting Cup
Sponsored by
Cwm Taf University Health Board (NHS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring Hydration, Fluid Intake, Frailty, Feasibility Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cwm Taf Morgannwg University Health BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

No Intervention

Other

Arm Label

Education Session

Prompting Cup

Control Group

Prompting Cup and Education

Arm Description

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.

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.

There will be no change to the care the participant receives from the District Nurse.

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.

Outcomes

Primary Outcome Measures

Recruitment of participants
Retention of participants
Retention of District Nurses
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.
Data Collection
Completion of Case Report Forms

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2019
Last Updated
January 21, 2020
Sponsor
Cwm Taf University Health Board (NHS)
Collaborators
PRIME Centre Wales
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1. Study Identification

Unique Protocol Identification Number
NCT04187859
Brief Title
Prompting And encouRaging Community Hydration Through EDucation
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cwm Taf University Health Board (NHS)
Collaborators
PRIME Centre Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Hydration, Fluid Intake, Frailty, Feasibility Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education Session
Arm Type
Other
Arm Description
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.
Arm Title
Prompting Cup
Arm Type
Other
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
There will be no change to the care the participant receives from the District Nurse.
Arm Title
Prompting Cup and Education
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Session
Intervention Description
Participants will receive an education session from their District Nurse, advising on how to improve their hydration.
Intervention Type
Device
Intervention Name(s)
Prompting Cup
Intervention Description
The Droplet Cup is an electronic prompting cup that emits a sound and/or light to encourage the participant to take a drink
Primary Outcome Measure Information:
Title
Recruitment of participants
Time Frame
12 Weeks
Title
Retention of participants
Time Frame
12 Weeks
Title
Retention of District Nurses
Time Frame
12 Weeks
Title
Acceptability and practicality of intervention for participants
Description
Participants will be approached to complete semi structured interviews which will explore the mechanisms and outcomes of the interventions.
Time Frame
12 Weeks
Title
Data Collection
Description
Completion of Case Report Forms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hydration risk score (G, U and L of the GULP tool)
Time Frame
12 weeks
Title
Tilburg Frailty Indicator Questionnaire
Time Frame
12 weeks
Title
Fluid and food frequency questionnaires
Description
BEV-15
Time Frame
12 weeks
Title
Fluid and food frequency questionnaires
Description
SSFFQ
Time Frame
12 weeks
Title
Hydration self-efficacy Questionnaire
Time Frame
12 weeks
Title
Quality of life Questionnaire
Description
EQ5D
Time Frame
12 weeks
Title
PANAS mood questionnaire
Time Frame
12 weeks
Title
Montreal cognitive assessment
Time Frame
12 weeks
Title
Semi-structured longitudinal interviews with District Nurses
Time Frame
12 weeks
Title
Long-term follow up by NHS databases
Time Frame
12 months
Title
Healthcare cost questionnaire
Time Frame
12 weeks
Title
Evaluation Questionnaire
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Lloydwin, PhD
Phone
01685 351456
Email
christina.lloydwin@wales.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Nott, BSc
Phone
01685 351457
Email
claire.nott@wales.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhian Beynon
Organizational Affiliation
Cwm Taf Morgannwg University Health Board
Official's Role
Study Director
Facility Information:
Facility Name
Cwm Taf Morgannwg University Health Board
City
Merthyr Tydfil
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Nott

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prompting And encouRaging Community Hydration Through EDucation

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