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

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: NCT03123601
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
University of Lisbon
Information provided by (Responsible Party):
Campus Neurológico Sénior

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Nursing Home Residents Device: Risk sign displays Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes: a Clinical Study Protocol
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Patients' satisfaction with the sign displays measured with a 7-point likert scale and open-ended questions. [ Time Frame: Minimum of 3 months ]
  2. 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 ]
  3. 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 ]
  4. Type and frequency of adverse events recorded during the period of the study [ Time Frame: Minimum of 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03123601


Locations
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Portugal
Campus Neurológico Sénior
Torres Vedras, Portugal, 2560-280 Torres Vedras
Sponsors and Collaborators
Campus Neurológico Sénior
University of Lisbon
Investigators
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Principal Investigator: Joaquim J Ferreira, MD, PhD Campus Neurológico Sénior

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Campus Neurológico Sénior
ClinicalTrials.gov Identifier: NCT03123601    
Other Study ID Numbers: CNS2017-01
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
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 Campus Neurológico Sénior:
Nursing home
Falls
Dysphasia
Choking
Dehydration
Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes