Nursing Home ResidentsNCT03123601
Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes
A study testing Risk sign displays in people with Nursing Home Residents, run by Campus Neurológico Sénior at 1 site in Portugal.
Trial summary
BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary aspiration among older adults in nursing and health care facilities, which contributes to its loss of independence and quality-of-life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nursing Home Residents
- What is being tested?
- Risk sign displays
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2016to 30 May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female staying at CNS nursing home for long term care;
- Risk of falling and/or dysphagia and/or dehydration defined by brief screening assessment;
- Being interested in participating in this study;
- Signing an informed consent form;
- Willing to comply with the monthly interviews required
- Eligibility validated by CNS health professionals in the multidisciplinary clinical meeting
Who cannot join
- Having significant active psychiatric problems (example: hallucinations, confusion, psychosis) that aggravates patient´s symptoms when dealing with the use of sign displays;
- Inability participate according to the CNS health professionals' judgement
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Campus Neurológico Sénior
Torres Vedras, 2560-280 Torres Vedras
About this study
Official title: Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes: a Clinical Study Protocol
BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary aspiration among older adults in nursing and health care facilities, which contributes to its loss of independence and quality-of-life. Is believed that improving communication among health professional decreases the number of adverse events in institutionalized patients. This study will evaluate the feasibility of a set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and will reflect on tailored interventions to manage these events in nursing homes.
METHODS AND ANALYSIS: This will be a national, single-center, feasibility study. All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.
Read the detailed description
- Preparation phase - teaching session for health professionals An initial teaching session will be held to train and familiarize health professionals with the usage of the sign displays and corresponding intervention procedures. The training will also consist of memorizing/training the definition given to falls, dehydration and pulmonary aspiration and redefining registration of such events in the software. During the training session, any queries from the professionals will be explained. The investigators expect the training will last 60 minutes. This training will be accompanied by written information with the definition of a fall, pulmonary aspiration and dehydration, and specific instructions on what procedures to undertake for each risk sign display. Additionally, the researcher will exemplify the procedure practically, if needed.
- Screening All patients will be invited to participate if they fulfil inclusion criteria. The nurse team from CNS nursing home will propose patients for recruitment and a multidisciplinary team will discuss and decided their study inclusion. In case of incapacity for the patients to give informed consent, family members will then be asked for consent and authorization of screening visit. Informed consent containing comprehensive information about objectives, duration, procedures, voluntariness and possible risks of study participation, will be obtained from patients before any study related proceedings. During the screening visit, an explanation of the objective and compliance needed for the study will be given to the participants and caregivers and all questions will be considered and answered. Demographics data, clinical manifestations and disease management, co-morbidities and past medical conditions will be obtained using a structured questionnaire. Also a brief clinical assessment of risk of falling, pulmonary aspiration and dehydration will be done. In the end of screening and risk assessment, the correspond risk displays will be given to patient by the investigator. 2.1) Clinical Scales Mini Mental State Examination (MMSE) The Mini Mental State Examination is a brief 30-point questionnaire that is used to quantitatively assess cognition. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating list of words, arithmetic, language use and comprehension, and copying a drawing. It can be used to screen for cognition impairment, to estimate the severity of cognitive impairment at a given point in time, to follow the course of cognitive changes in an individual over time, and to document an individual's response to treatment. Time Up and Go (TUG) Time Up and Go is a quick capacity measure to for functional mobility and a good predictor of subject's ability to independently walk outside safely. This clinical test is recommended by MDS review of measurement Instruments to assess posture, gait, and balance in Parkinson's disease and in the latest physiotherapy guidelines to Parkinson's disease. In this test is asked to participant to get up from a standard chair, walk 3m at a comfortable and safe speed and then turn walk to back to sit in the chair. Morse Falls Scale The Morse fall scale assesses the risk of falling for hospital in-patients or those in long-term care, in particular evaluates: falls history, the presence of comorbidities, the use of walking aids, mental status and whether or not patients are on intravenous therapy. Swallowing Disturbance Questionnaire (SDQ) The Swallowing Disturbance Questionnaire (SDQ) for PD patients is a validated self-reporting 15-item questionnaire on swallowing disturbances that appear in the oral and pharyngeal phases of swallowing. Fourteen questions rated by a four-point scale (0 for no disturbance and 3 for severe disturbance), and one ''yes/no'' question (yes was scored 2.5 and no was scored 0.5). GULP Dehydration Risk Screening Tool The GULP is a screening tool to assess geriatric dehydration risk. It includes a score from 0 to 7 points for three categories (24 h fluid intake; urine colour; clinical risk factors for dehydration). Based on results, the GULP tool recommends an hydration management plan, engaging like this the patient in self-monitoring of urine and verbal prompts.
- Diary Record In the end of each nursing shift all events of falls, near falls, dehydration and pulmonary aspiration will be recorded in documents specifically created for that purpose by the working staff of CNS.
- Monthly Visits At the end of each month, an interview will be performed to patients and a self-completed questionnaire will be handed to health professionals. Both will be questioned regarding overall acceptability levels and asked for any encountered problems regarding the use of the displays. Additionally, these moments will include questions on clarity of the instructions, reminder of the event definitions and the registration procedures. Importantly, investigators recognize that the visit interview is not flawless, because participants may have forgotten some of their complaints by the time of the visit interview. To their knowledge, there is no study that has previously studied whether recall interviews must be made weekly or whether more-frequent visits would be sufficient to obtain a reliable estimate of information. For this study, a monthly period was considered reasonable and particularly more helpful and feasible in future large trials with long follow-up periods. All visit interviews will be performed by the investigator and will take no more than 10 minutes.
- Monthly reports In the end of each month, as strategy to keep health professionals informed and to remember the importance of registering, a newsletter will be sent to all CNS staff. This will contain information about the study duration and will present a summary of the number of participants in the study (number of patients recruited and number of drop-outs) and of the event recorded in that month.
- Data collection of events It will also collect, in relation to all CNS residents, historical data related to falls, dehydration and pulmonary aspiration events retrospectively from medical and nursing chats within the period of the study and the same period, one year before.
- Conditions
- Nursing Home Residents
- Being tested
- Risk sign displays
- Keywords
- Nursing home, Falls, Dysphasia, Choking, Dehydration
- Medical subject headings
- Aphasia, Airway Obstruction, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk sign displaysDevice
Set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and reflect on tailored interventions to manage these events in nursing homes. Risk sign displays are:
- Small, lightweight rubber coloured bracelets with phrases related with the different risks: "prevent rather than fall", "contain to protect", "drink to hydrate" and "avoid choking".
- Small and coloured signposts next to head of patients bed that are believed to offer some key advantages and increase technically the quality of immediate communication of information and data regarding procedures. It is expected to have greater subject compliance once they will have discrete messages with thoughtful design and colour.
| Study group | Role | What they receive |
|---|---|---|
| Risk sign displays | Experimental | At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts. Receives: Device: Risk sign displays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' adherence trough the number of times and reasons to taken off the risk display or refused to use during the period of the study and/or withdrawing from the study
Measured: Minimum of 3 months
Secondary outcomes (4)
Patients' satisfaction with the sign displays measured with a 7-point likert scale and open-ended questions.
Measured: Minimum of 3 months
Health professionals' satisfaction measured with sign displays through 7-point likert scale and open-ended questions regarding the overall benefits of using the displays and overall perception of its impact on decreasing risk.
Measured: Minimum of 3 months
Comparison to historical medical and nursing charts data review of the relative frequency of number of events per number of days of hospitalization registered during the period of the study, with in an equal period of time, one year before.
Measured: Minimum of 3 months
Type and frequency of adverse events recorded during the period of the study
Measured: Minimum of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Nov 2016
- Primary completion30 Apr 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing Home ResidentsStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Neurológico Sénior
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon
- Responsible party
- Sponsor
- Investigators
- Joaquim J Ferreira, MD, PhD, Principal investigator, Campus Neurológico Sénior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123601
- Sponsor's protocol ID
- CNS2017-01
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duarte M, Bouca-Machado R, Domingos J, Godinho C, Ferreira JJ; CNS risk prompt display study group. Feasibility of using risk prompts to prevent falls, dehydration and pulmonary aspiration in nursing homes: a clinical study protocol. Pilot Feasibility Stud. 2018 Jan 25;4:39. doi: 10.1186/s40814-018-0236-1. eCollection 2018.
PubMed 29416872
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes: a Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT03123601
- Acronym / sponsor ID
- CNS2017-01
- Conditions
- Nursing Home Residents
- Keywords
- Nursing home, Falls, Dysphasia, Choking, Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Campus Neurológico SéniorUniversity, hospital or other
- Collaborators
- University of Lisbon
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 21 Apr 2017 (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.
BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary aspiration among older adults in nursing and health care facilities, which contributes to its loss of independence and quality-of-life. Is believed that improving communication among health professional decreases the number of adverse events in institutionalized patients. This study will evaluate the feasibility of a set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and will reflect on tailored interventions to manage these events in nursing homes.
METHODS AND ANALYSIS: This will be a national, single-center, feasibility study. All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.
Detailed description
- Preparation phase - teaching session for health professionals An initial teaching session will be held to train and familiarize health professionals with the usage of the sign displays and corresponding intervention procedures. The training will also consist of memorizing/training the definition given to falls, dehydration and pulmonary aspiration and redefining registration of such events in the software. During the training session, any queries from the professionals will be explained. The investigators expect the training will last 60 minutes. This training will be accompanied by written information with the definition of a fall, pulmonary aspiration and dehydration, and specific instructions on what procedures to undertake for each risk sign display. Additionally, the researcher will exemplify the procedure practically, if needed.
- Screening All patients will be invited to participate if they fulfil inclusion criteria. The nurse team from CNS nursing home will propose patients for recruitment and a multidisciplinary team will discuss and decided their study inclusion. In case of incapacity for the patients to give informed consent, family members will then be asked for consent and authorization of screening visit. Informed consent containing comprehensive information about objectives, duration, procedures, voluntariness and possible risks of study participation, will be obtained from patients before any study related proceedings. During the screening visit, an explanation of the objective and compliance needed for the study will be given to the participants and caregivers and all questions will be considered and answered. Demographics data, clinical manifestations and disease management, co-morbidities and past medical conditions will be obtained using a structured questionnaire. Also a brief clinical assessment of risk of falling, pulmonary aspiration and dehydration will be done. In the end of screening and risk assessment, the correspond risk displays will be given to patient by the investigator. 2.1) Clinical Scales Mini Mental State Examination (MMSE) The Mini Mental State Examination is a brief 30-point questionnaire that is used to quantitatively assess cognition. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating list of words, arithmetic, language use and comprehension, and copying a drawing. It can be used to screen for cognition impairment, to estimate the severity of cognitive impairment at a given point in time, to follow the course of cognitive changes in an individual over time, and to document an individual's response to treatment. Time Up and Go (TUG) Time Up and Go is a quick capacity measure to for functional mobility and a good predictor of subject's ability to independently walk outside safely. This clinical test is recommended by MDS review of measurement Instruments to assess posture, gait, and balance in Parkinson's disease and in the latest physiotherapy guidelines to Parkinson's disease. In this test is asked to participant to get up from a standard chair, walk 3m at a comfortable and safe speed and then turn walk to back to sit in the chair. Morse Falls Scale The Morse fall scale assesses the risk of falling for hospital in-patients or those in long-term care, in particular evaluates: falls history, the presence of comorbidities, the use of walking aids, mental status and whether or not patients are on intravenous therapy. Swallowing Disturbance Questionnaire (SDQ) The Swallowing Disturbance Questionnaire (SDQ) for PD patients is a validated self-reporting 15-item questionnaire on swallowing disturbances that appear in the oral and pharyngeal phases of swallowing. Fourteen questions rated by a four-point scale (0 for no disturbance and 3 for severe disturbance), and one ''yes/no'' question (yes was scored 2.5 and no was scored 0.5). GULP Dehydration Risk Screening Tool The GULP is a screening tool to assess geriatric dehydration risk. It includes a score from 0 to 7 points for three categories (24 h fluid intake; urine colour; clinical risk factors for dehydration). Based on results, the GULP tool recommends an hydration management plan, engaging like this the patient in self-monitoring of urine and verbal prompts.
- Diary Record In the end of each nursing shift all events of falls, near falls, dehydration and pulmonary aspiration will be recorded in documents specifically created for that purpose by the working staff of CNS.
- Monthly Visits At the end of each month, an interview will be performed to patients and a self-completed questionnaire will be handed to health professionals. Both will be questioned regarding overall acceptability levels and asked for any encountered problems regarding the use of the displays. Additionally, these moments will include questions on clarity of the instructions, reminder of the event definitions and the registration procedures. Importantly, investigators recognize that the visit interview is not flawless, because participants may have forgotten some of their complaints by the time of the visit interview. To their knowledge, there is no study that has previously studied whether recall interviews must be made weekly or whether more-frequent visits would be sufficient to obtain a reliable estimate of information. For this study, a monthly period was considered reasonable and particularly more helpful and feasible in future large trials with long follow-up periods. All visit interviews will be performed by the investigator and will take no more than 10 minutes.
- Monthly reports In the end of each month, as strategy to keep health professionals informed and to remember the importance of registering, a newsletter will be sent to all CNS staff. This will contain information about the study duration and will present a summary of the number of participants in the study (number of patients recruited and number of drop-outs) and of the event recorded in that month.
- Data collection of events It will also collect, in relation to all CNS residents, historical data related to falls, dehydration and pulmonary aspiration events retrospectively from medical and nursing chats within the period of the study and the same period, one year before.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.
| Arm | Type | Receives |
|---|---|---|
| Risk sign displays | Experimental | Device: Risk sign displaysAt baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female staying at CNS nursing home for long term care;
- Risk of falling and/or dysphagia and/or dehydration defined by brief screening assessment;
- Being interested in participating in this study;
- Signing an informed consent form;
- Willing to comply with the monthly interviews required
Key exclusion criteria (2 listed)
- Having significant active psychiatric problems (example: hallucinations, confusion, psychosis) that aggravates patient´s symptoms when dealing with the use of sign displays;
- Inability participate according to the CNS health professionals' judgement
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 |
|---|---|---|
| Risk sign displaysSet of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and reflect on tailored interventions to manage these events in nursing homes. Risk sign displays are: * Small, lightweight rubber coloured bracelets with phrases related with the different risks: "prevent rather than fall", "contain to protect", "drink to hydrate" and "avoid choking". * Small and coloured signposts next to head of patients bed that are believed to offer some key advantages and increase technically the quality of immediate communication of information and data regarding procedures. It is expected to have greater subject compliance once they will have discrete messages with thoughtful design and colour. | Device | Risk sign displays |
Primary outcome
Patients' adherence trough the number of times and reasons to taken off the risk display or refused to use during the period of the study and/or withdrawing from the study
Time frame: Minimum of 3 months
4 secondary outcomes
Patients' satisfaction with the sign displays measured with a 7-point likert scale and open-ended questions.
Time frame: Minimum of 3 months
Health professionals' satisfaction measured with sign displays through 7-point likert scale and open-ended questions regarding the overall benefits of using the displays and overall perception of its impact on decreasing risk.
Time frame: Minimum of 3 months
Comparison to historical medical and nursing charts data review of the relative frequency of number of events per number of days of hospitalization registered during the period of the study, with in an equal period of time, one year before.
Time frame: Minimum of 3 months
Type and frequency of adverse events recorded during the period of the study
Time frame: Minimum of 3 months
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 21 Mar 2019.
- Derived from this study: PubMed 29416872Duarte M, Bouca-Machado R, Domingos J, Godinho C, Ferreira JJ; CNS risk prompt display study group. Feasibility of using risk prompts to prevent falls, dehydration and pulmonary aspiration in nursing homes: a clinical study protocol. Pilot Feasibility Stud. 2018 Jan 25;4:39. doi: 10.1186/s40814-018-0236-1. eCollection 2018.
- 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.
Joaquim J Ferreira, MD, PhD principal investigator
Campus Neurológico Sénior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk sign displays in people with Nursing Home Residents, run by Campus Neurológico Sénior at 1 site in Portugal.
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 6 inclusion and 2 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 21 Mar 2019. 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 Portugal. 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?
Patients' adherence trough the number of times and reasons to taken off the risk display or refused to use during the period of the study and/or withdrawing from the study (time frame: Minimum of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123601, which also lists 1 linked publication.
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 21 Mar 2019.