NCT04281550

Brief Summary

The study aimed to provide evidence of the feasibility of implementing a multi-component intervention for optimising hydration in people with dementia living in care homes. To undertake a multi method feasibility study to investigate the suitability of methods and outcome measures for future research. Objectives:

  1. 1.Explore personal barriers experienced by people with dementia regarding drinking in care home contexts
  2. 2.Explore professional and organisational perspectives of approaches to optimal hydration of residents with dementia and the barriers in everyday practice
  3. 3.Develop a multi-component intervention to enhance hydration for residents in collaboration with care home staff, mental health and geriatric specialists, and residents' family
  4. 4.Assess the feasibility of implementing the intervention in care homes, and impact on recommended daily intake of fluids
  5. 5.Explore the impact of the intervention on daily fluid intake, and designing suitable secondary outcome measures - admission to hospital due to dehydration, falls, laxative use, urinary tract infection, upper respiratory tract infection and skin breakdown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

February 20, 2020

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fluid intake

    Change in proportion of the resident population with higher daily fluid intake

    6 months

  • Fluid intake 2

    Change in mean fluid intake of drinks that are a) offered and b) consumed

    6 months

Secondary Outcomes (8)

  • Hydration care plan

    6 months

  • Hospital admission

    6 months

  • Death

    6 months

  • Referral to GP

    6 months

  • UTI

    6 months

  • +3 more secondary outcomes

Study Arms (1)

Think drink intervention

EXPERIMENTAL

The Think Drink multicomponent hydration intervention was introduced into the intervention group care homes through a staff workshop.

Other: Think Drink

Interventions

The Think Drink Guide that had three interacting components. The 'policy' component was directed at the governance of the care home, whereas 'practice' components were directed at hydration procedures and processes, and 'educational' components that provided learning resources for care home staff to develop knowledge and understanding of hydration care. Think Drink was implemented through a short awareness-raising educational programme and accompanying information booklet detailing a range of practices (including organisational, system and individual practice) designed to encourage hydration.

Think drink intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • must be a care home resident
  • assent for participation is provided by their surrogate decision maker
  • must be able to drink oral fluids

You may not qualify if:

  • unable to drink oral fluids
  • receiving end of life care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Glenda Cook, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study was a three-phase multi-method design consisting of analysis of the empirical grounds for the hydration intervention, development of a multi-component hydration intervention and a feasibility cluster trial of the intervention. The first phase constituted of a survey of care homes, a systematic review-informed review of previous literature and collection of professional perspectives. Second phase was the development the intervention through five workshop events. Finally, the feasibility phase compared 6 intervention homes and 5 control homes in North East England, over a 3-month period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of nursing

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

September 1, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations