The ElderlyNCT04242745
The Effect of Audible Alarm on the Fluid Consumption of the Elderly
A study testing Intervention group in people with The Elderly, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Elderly
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2017to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Criteria for inclusion in the study were being aged 65 or over, not having a fluid deficiency and living in nursing home.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Audible Alarm on the Fluid Consumption of The Elderly Living in a Nursing Home: A Randomized, Controlled Trial
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.
- Conditions
- The Elderly
- Being tested
- Intervention group, Control group
- Keywords
- Elderly, fluid consumption, fluid deficiency, nursing home, audible alarm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention group; Behavioral: Control group |
| Control group | No intervention | The control group was given only education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, about three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start27 Jul 2017
- Primary completion1 Feb 2018
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perihan ÇETİN, Izmir Katip Celebi University
- Investigators
- Perihan ÇETİN, Assistant Professor, PhD, Study chair, Izmir Katip Celebi Universityİsmet EŞER, Professor, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242745
- Sponsor's protocol ID
- 17-7.1/36; 27.07.2017
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Audible Alarm on the Fluid Consumption of The Elderly Living in a Nursing Home: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04242745
- Acronym / sponsor ID
- 17-7.1/36; 27.07.2017
- Conditions
- The Elderly
- Keywords
- Elderly, fluid consumption, fluid deficiency, nursing home, audible alarm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention group, Behavioral: Control groupProcedure/Surgery:The intervention group was given education and a wristwatch which gave an audible alarm to remind them to drink liquid. |
| Control group | No intervention | –The control group was given only education. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Criteria for inclusion in the study were being aged 65 or over, not having a fluid deficiency and living in nursing home.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThe 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. | Behavioural | Intervention group |
| Control groupThe 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perihan ÇETİN, Assistant Professor, PhD study chair
Izmir Katip Celebi University
İsmet EŞER, Professor study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with The Elderly, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of fluids taken by the elderly (time frame: Through study completion, about three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.