NCT04242745

Brief Summary

Research shows that older people need reminders to increase fluid consumption. The aim of the research was to investigate the effect of an audible alarm on the fluid consumption of old people living in a nursing home. The research was conducted as a single-blind, randomized controlled, prospective experimental study on the pre-test post-test model. The study was performed between 27 July 2017 and 1 February 2018 at a nursing home in the west of Turkey. Out of 979 in nursing home who conformed to the inclusion criteria of the study, 100 (intervention group (n: 50) and control group (n: 50) were voluntarily included in the sample. The intervention group was given education and a wristwatch which gave an audible alarm to remind them to drink liquid, the control group was given only education. The old people in both groups were monitored before the education, after the education, after the audible alarm and 15 days after the audible alarm every three days on total of 12 days. The amount of liquid that the elderly should drink daily was determined according to Gaspar formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

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

July 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 16, 2020

Last Update Submit

January 24, 2020

Conditions

Keywords

Elderlyfluid consumptionfluid deficiencynursing homeaudible alarm

Outcome Measures

Primary Outcomes (2)

  • Total amount of fluids taken by the elderly

    The elderly in the intervention and control groups; before the education (on the 2nd, 3rd and 4th days of the study), after the education (on the 6th, 7th and 8th days of the research), after the audible stimulus (on the 9th, 10th and 11th days of the research), and 15 days after the audible stimulus monitoring (26, On the 27th and 28th days), the total amount of fluid he consumed daily was measured and recorded by the nurse.

    Through study completion, about three years

  • Fluid deficit of the elderly

    The elderly in the intervention and control groups; before the training (on the 2nd, 3rd and 4th days of the study), after the training (on the 6th, 7th and 8th days of the research), after the audible stimulus (on the 9th, 10th and 11th days of the research), and 15 days after the audible stimulus monitoring (26, On the 27th and 28th days), the 24-hour amount of urine and the urine concentration was measured and recorded by the nurse.

    Through study completion, about three years

Study Arms (2)

Intervention group

EXPERIMENTAL

Procedure/Surgery:The intervention group was given education and a wristwatch which gave an audible alarm to remind them to drink liquid.

Behavioral: Intervention groupBehavioral: Control group

Control group

NO INTERVENTION

The control group was given only education.

Interventions

The elderly in this group were trained using the "For Your Health For Fluid" training booklet and a projection device, and after training, all individuals were given a training booklet. The training was carried out individually in a room reserved for training and took an average of 25-30 minutes. A Beyid wristwatch was used. This spoke the time in Turkish, every hour on the hour. In this way, the old people were reminded to drink a glass of liquid each hour. The watch had an alarm capability, and could be taken on to sleep mode at night in order not to wake the old people.

Intervention group
Control groupBEHAVIORAL

The elderly in this group were trained using the "For Your Health For Fluid" training booklet and a projection device, and after training, all individuals were given a training booklet. The training was carried out individually in a room reserved for training and took an average of 25-30 minutes.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsStratified randomization scheme of the intervention and control group is shown below Variable intervention group Control group Total Age 65-74 Years 13 13 26 75-84 Years 29 28 57 85 Years and Over 8 9 17 Gender Women 31 30 61 Male 19 20 39 Education Status Primary School 17 18 35 High School and above 33 32 65 Total 50 50 100
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Being visually or aurally impaired,
  • Being bedridden,
  • Not being able to take liquids orally, Having health problems such as fever,
  • Vomiting, diarrhea or kidney disease causing fluid loss,
  • Taking diuretic medication and using more than more than five doses per day,
  • Having a diagnosis of a disease such as kidney failure or cardiac insufficiency requiring restriction of fluids, or having a diagnosis of neurological or psychiatric dysfunction, or dementia or Alzheimer's.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Katip Çelebi University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Perihan ÇETİN, Assistant Professor, PhD

    Izmir Katip Celebi University

    STUDY CHAIR
  • İsmet EŞER, Professor

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD,

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 27, 2020

Study Start

July 27, 2017

Primary Completion

February 1, 2018

Study Completion

December 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations