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The Effect of Audible Alarm on the Fluid Consumption of the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242745
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Perihan ÇETİN, Izmir Katip Celebi University

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.


Condition or disease Intervention/treatment Phase
The Elderly Behavioral: Intervention group Behavioral: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of an Audible Alarm on the Fluid Consumption of The Elderly Living in a Nursing Home: A Randomized, Controlled Trial
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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

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.


Behavioral: Control group
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.

No Intervention: Control group
The control group was given only education.



Primary Outcome Measures :
  1. Total amount of fluids taken by the elderly [ Time Frame: Through study completion, about three years ]
    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.

  2. Fluid deficit of the elderly [ Time Frame: Through study completion, about three years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Stratified 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

Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Criteria for inclusion in the study were being aged 65 or over, not having a fluid deficiency and living in nursing home.

Exclusion Criteria:

  • Exclusion criteria were having an education level of less than primary education
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242745


Locations
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Turkey
İzmir Katip Çelebi University
İzmir, Turkey
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
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Study Chair: Perihan ÇETİN, Assistant Professor, PhD Izmir Katip Celebi University
Study Director: İsmet EŞER, Professor Ege University
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Responsible Party: Perihan ÇETİN, Assistant Professor, PhD,, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT04242745    
Other Study ID Numbers: 17-7.1/36; 27.07.2017
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Perihan ÇETİN, Izmir Katip Celebi University:
Elderly
fluid consumption
fluid deficiency
nursing home
audible alarm