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Accidental FallCHRONOFALLSNCT04367298

Chronoprevention in Hospital Falls of Older People

An observational study of Accidental Fall, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Accidental falls in hospitals are serious events concerning the safety of the patients. Recent studies demonstrated that the time of falls is a key factor to be considered in prevention. It has been shown that the time of day, the day of the week and the month of the year impact on the occurrence of falls. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Accidental Fall
What is being tested?
Chronoprevention
How many people
200 participants
Where
1 siteSpain
Study dates
1 Jan 2018to 1 Jun 2022
How long will I take part?
34 Months
Phase
Observational
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
  • No healthy volunteers
  • Older adult

Study population: Patients over 65 years who suffer one/several fall/s during their hospital admission to four hospital (one teaching and three non-teaching hospitals)

Who may be able to join

  • Patients who suffer a hospital fall
  • Accept and sing the informed consent
  • Nurses in charge of the care of patients who suffer a fall
  • Accept and sing the informed consent

Who cannot join

  • Do not accept and sign the informed consent
  • Nurses who do not care for a patient suffering a fall
  • Do no accept and sign the informed consent

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Maimónides Biomedical Research Institute of Córdoba

    Córdoba, 14004

Other trials in Spain

About this study

Official title: Chronoprevention in Hospital Falls of Older People: A Nursing Intervention CHRONOFALLS

Accidental falls in hospitals are serious events concerning the safety of the patients. Recent studies demonstrated that the time of falls is a key factor to be considered in prevention. It has been shown that the time of day, the day of the week and the month of the year impact on the occurrence of falls.

The aim of this project is to know the effect of the application of a program of preventive measures based on the temporal patterns of the risk factors on the hospital fall occurrence. A mixed method research design will be conducted. Three phases will be carry out: 1) Longitudinal prospective study in two parts: a) audits and seminars of health professionals focused on an effective and efficient hospital falls register. Cosinor and Multi-Component analyses will be performed to obtain temporal patterns of the hospital falls and their related variables. b) Implementation of a based-temporal patterns, multidimensional prevention program. 2) Retrospective study of falls registered in institutional databases. 3) Qualitative study based on focus groups (physicians, nurses and nursing assistants).

It is imperative to study temporal patterns of hospital falls to effectively and comprehensively define the etiology of falls, and therefore, design preventive strategies. A reduction of the number of in-hospital falls and related injuries is expected, as well as, an improvement of the quality of life of patients. Considering temporal patterns, and levels of mood and sleep of healthcare professionals will achieve an improvement of patient safety.

Read the detailed description

-Design

A mixed-method research will be carried out. Three different study design will be used:

Phase 1. Prospective longitudinal study in 2 steps:

  • A first step, of 18 months, in which a first intervention of audits and seminars in health professionals will be carried out, focused on an effective and efficient registry of hospital falls in older people. This first phase is crucial to identify temporal patterns of falls in relation to specific intrinsic and extrinsic risk factors among hospitalized older people; as well as the levels of fatigue/sleepiness, attention and cognitive functionality of the health professionals who attend to an in-hospital fall.
  • A second step, of application of a multidimensional prevention program for 15 months focused on organizational, educational and behavioral elements; applied to admitted older people and health professionals.

Phase 2. Retrospective study of the fall records found in the institutional databases of the study centers, in the period between January 2018 - September 2020. This period covers the first (January 2018 - May 2019) and the second phase (June 2019 - September 2020) of the project, previously indicated.

Phase 3. Descriptive exploratory study with a qualitative approach, focus groups made up of health professionals: doctors, nurses and nursing assistants who provide and have provided their professional services in the field of study, in the periods in which the studies have been carried out. longitudinal and retrospective previously mentioned.

Conditions
Accidental Fall
Being tested
Chronoprevention
Keywords
accidental falls, older people, nursing care, nursing, temporal patterns, prevention, circadian rhythms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChronopreventionBehavioural

    Preventive measures will be focused on organizational, educational and behavioural elements related to older people and healthcare professionals

Study groups in NCT04367298
Study groupRoleWhat they receive
Chronoprevention in hospital fallsImplementation of a hospital preventive measures program: adjusted to the identification of temporal patterns of falls and relative risk factors of falls.
Receives: Behavioral: Chronoprevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participant with Hospital falls

    Records of falls coded in the International Classification of Diseases (ICD-10) between codes W00-W19.9

    Measured: Through study completion, an average of 1 month

Secondary outcomes (7)

  1. Chronotype of patient

    Morningness-Eveningness according to Horne-Östberg Questionnaire (1976). Scores can range from 18-86. Scores of 41 and below indicate "evening types". Scores of 59 and above indicate "morning types". Scores between 42 and 58 indicate "intermediate types".

    Measured: Through study completion, an average of 1 month

  2. Quality of life of patient

    Short Form 36 Health Survey (SF-36) (Spanish version 2) (Alonso et al. 1996). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Measured: Through study completion, an average of 1 month

  3. General health status of patient

    28-Item General Health Questionnaire (GHQ28) (Spanish version) (Lobo et al. 1985). Scores can range from 0-84. Higher GHQ-28 scores indicate higher levels of distress

    Measured: Through study completion, an average of 1 month

  4. Sleep pattern of the healthcare professionals

    Pittsburgh Sleep Quality Index (Spanish version) (Macías \& Royuela, 1996). Score can range from 0-21 with the higher total score indicating worse sleep quality.

    Measured: Through study completion, an average of 1 month

  5. Chronotype of the healthcare professionals

    Chronotype according to Horne-Östberg Questionnaire (1976). Scores can range from 18-86. Scores of 41 and below indicate "evening types". Scores of 59 and above indicate "morning types". Scores between 42 and 58 indicate "intermediate types".

    Measured: Through study completion, an average of 1 month

  6. Quality of life of the healthcare professionals

    Short Form 36 Health Survey (SF-36) (Spanish version 2) (Alonso et al. 1996). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Measured: Through study completion, an average of 1 month

  7. General health status of the healthcare professional

    28-Item General Health Questionnaire (GHQ28) (Spanish version) (Lobo et al. 1985). Scores can range from 0-84. Higher GHQ-28 scores indicate higher levels of distress

    Measured: Through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start1 Jan 2018
  3. Primary completion1 Sep 2020
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (actual)
Target duration
34 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04367298
Sponsor's protocol ID
PI-0360-2017
Acronym
CHRONOFALLS
Status last verified
Oct 2022
First submitted
23 Apr 2020
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Lopez-Soto PJ, Lopez-Carrasco JC, Fabbian F, Minarro-Del Moral RM, Segura-Ruiz R, Hidalgo-Lopezosa P, Manfredini R, Rodriguez-Borrego MA. Chronoprevention in hospital falls of older people: protocol for a mixed-method study. BMC Nurs. 2021 Jun 6;20(1):88. doi: 10.1186/s12912-021-00618-y.

    PubMed 34092223

  • Lopez-Soto PJ, Rodriguez-Cortes FJ, Minarro-Del Moral RM, Medina-Valverde MJ, Segura-Ruiz R, Hidalgo-Lopezosa P, Manfredini R, Rodriguez-Borrego MA; CHRONOFALLS project collaborators. CHRONOFALLS: A multicentre nurse-led intervention in the chronoprevention of in-hospital falls in adults. BMC Nurs. 2023 May 5;22(1):149. doi: 10.1186/s12912-023-01322-9.

    PubMed 37143072

Questions about this trial

What is this clinical trial studying?

An observational study of Accidental Fall, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

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 4 inclusion and 3 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 13 Oct 2022. 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 Spain. 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?

Number of Participant with Hospital falls (time frame: Through study completion, an average of 1 month). 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 NCT04367298, which also lists 2 linked publications.

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 13 Oct 2022.

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