Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes

March 19, 2019 updated by: Campus Neurológico Sénior

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.
  6. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Torres Vedras, Portugal, 2560-280 Torres Vedras
        • Campus Neurológico Sénior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Risk sign displays
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.
Device: Risk sign displays

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Minimum of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patients' satisfaction with the sign displays measured with a 7-point likert scale and open-ended questions.
Time Frame: Minimum of 3 months
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
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
Minimum of 3 months
Type and frequency of adverse events recorded during the period of the study
Time Frame: Minimum of 3 months
Minimum of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Campus Neurológico Sénior

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Lisbon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joaquim J Ferreira, MD, PhD, Campus Neurológico Sénior

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNS2017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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