NCT04187859

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 23, 2020

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

November 27, 2019

Last Update Submit

January 21, 2020

Conditions

Frailty

Keywords

HydrationFluid IntakeFrailtyFeasibility Study

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (12)

  • Hydration risk score (G, U and L of the GULP tool)

    12 weeks

  • Tilburg Frailty Indicator Questionnaire

    12 weeks

  • Fluid and food frequency questionnaires

    12 weeks

  • Fluid and food frequency questionnaires

    12 weeks

  • Hydration self-efficacy Questionnaire

    12 weeks

  • +7 more secondary outcomes

Study Arms (4)

Education Session

OTHER

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

Prompting Cup

OTHER

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

Control Group

NO INTERVENTION

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

Prompting Cup and Education

OTHER

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 SessionDevice: Prompting Cup

Interventions

Education SessionBEHAVIORAL

Participants will receive an education session from their District Nurse, advising on how to improve their hydration.

Education SessionPrompting Cup and Education
Prompting CupDEVICE

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

Prompting CupPrompting Cup and Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cwm Taf Morgannwg University Health Board

Merthyr Tydfil, United Kingdom

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rhian Beynon

    Cwm Taf Morgannwg University Health Board

    STUDY DIRECTOR

Central Study Contacts

Christina Lloydwin, PhD

CONTACT

01685 351456christina.lloydwin@wales.nhs.uk

Claire Nott, BSc

CONTACT

01685 351457claire.nott@wales.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 5, 2019

Study Start

January 6, 2020

Primary Completion

September 1, 2020

Study Completion

May 1, 2021

Last Updated

January 23, 2020

Record last verified: 2019-10

Locations

GB(1)