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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04242745
Other study ID # 17-7.1/36; 27.07.2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2017
Est. completion date December 20, 2019

Study information

Verified date January 2020
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 20, 2019
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Izmir Katip Çelebi University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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