ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of a Multivariable Prognostic PREdiction Model for 1-year Risk of FALLing in Community-dwelling Older Adults in a Non-clinical Setting (PREFALL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03608709
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Gustav Valentin Blichfeldt Sørensen, Aalborg Universitetshospital

Brief Summary:

Falls in community-dwelling older adults is a frequent problem with an incidence of 30 % in over-65s and 50 % in over-80s. Incidences are expected to increase significantly in the future due to population aging. For instance, as of 2017, the global population older than 65 years is estimated to be 962 million and will increase to 1.4 and 2.1 billion in 2030 and 2050 respectively. In Denmark, falls are the most common accidents among older adults with around 36,000 fall accidents seen annually by the Danish health services and approximately 680 deaths yearly. This high frequency of fall accidents may also support the fact that falls in Denmark are the fourth most common reason for years lived with disability, thereby giving rise to reduced quality of life. Also, falls are associated with elevated morbidity, mortality, poorer physical functioning and early admission to long-term care facilities. Thus, this frequent and escalating problem of fall accidents is of major concern.

Fall prevention is therefore highly relevant. It is recognised that fall-preventive strategies should take on a multifaceted approach due the multifactorial aetiology of falls. This is substantiated by more than 400 risk factors of falling that have now been identified. These spread across different domains including socio-demographics, medical conditions (e.g. atrial fibrillation), medication, physical performance (e.g. reduced lower extremity strength or reaction time), psychology (e.g. depression or fear of falling) and cognition (e.g. global cognitive impairment or reduced executive functioning).

In order to aid health care professionals in targeting fall-preventive interventions, individual assessments of fall risk are imperative. In Denmark, municipalities are obliged to perform preventive initiatives to preserve the physical, mental and social health along with the functional capacity and quality of life of their older adults. The aim of these initiatives is to enable the older adults to live an independent and meaningful life for as long as possible. Recently, The Danish Health Authority released an updated manual to support this work. This emphasised the need for development of a validated prediction model to be used in a municipally environment to identify older adults at risk of falling. This is due to the abovementioned consequences of falls. To the knowledge of the authors, this is in line with literature being sparse on prognostic prediction models on falls in community-dwelling older adults with data collected outside a clinical environment (i.e. hospitals, GPs and screening or assessment centres).

Objectives:

Primary:

To develop and internally validate a multifactorial prognostic prediction model on fall risk in community-dwelling older adults in a non-clinical setting. The intended use of the model is, for municipalities, to identify and refer citizens with high risk of falls to fall-preventive interventions.

Secondary:

  1. To estimate time-consumption for the final prediction model.
  2. To describe the prevalence of arrhythmias in community-dwelling older adults.

Condition or disease
Accidental Fall Fall

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Multivariable Prognostic PREdiction Model for 1-year Risk of FALLing in Community-dwelling Older Adults in a Non-clinical Setting
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls




Primary Outcome Measures :
  1. Number of falls [ Time Frame: 1 year follow up ]

    Falls will be monitored using monthly prepaid fall calendars and validated by a phone call if a fall is registered. Also, circumstances of the fall will be asked about in the phone call.

    Blinding:

    Assessors of the outcome will be naturally blinded towards the predictors due to test results not being available before end of follow-up. Also, assessors of the outcome will be blinded to the questionnaire results by not having access to these in REDCap



Secondary Outcome Measures :
  1. Time consumption for the final prediction model [ Time Frame: After 6 months ]
    Time consumption for both the tests and questionnaire

  2. Arrhythmias [ Time Frame: After 1 year ]
    Prevalence of arrhythmias will be calculated as the proportion of participants having arrhythmias in the study population at the time of the baseline measurements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The target group of PHVs is community-dwelling older adults primarily +75 years old. PHVs are not offered to citizens already receiving local authority home help except for those receiving help with cleaning. As of 2017, the target group of PHVs in the municipality of Hjørring consisted of approximately 4,800 community-dwelling older adults of which 2,053 received a PHV. We expect to include 400 participants from PHVs. Data collection will be performed by trained nurses.

- The target group of SACs is primarily retirees (+65 years old), but also early retirees (+60 years old) with reduced physical, psychological or social functional capacity. As of 2018, 318 citizens of the target group attend SACs in the municipality of Hjørring weekly. We expect to include 100 participants from SACs. However, in case of economical, administrative or timing problems, this may alter in both PHV and SACs. The activity centres are staffed with health care workers collecting data for this study.

Criteria

Inclusion Criteria:

  1. Community-dwelling older adults
  2. 75 years old or above

Exclusion Criteria:

  1. Presence of acute illness defined by the presence of a participant-reported experience of illness arisen within 7 days prior to inclusion impairing their everyday functioning in such a way that they opt out of social activities outside their homes while this state is present.
  2. Unable to understand Danish evaluated by the data collectors.
  3. Diagnosed with dementia.
  4. Unable to stand up for 60 seconds without support and visually fixate on an object at the same time. Support is defined by any assistive devices or help from another person.

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): NCT03608709


Contacts
Contact: Gustav V B Soerensen, MD 004597660844 gustav.soerensen@rn.dk

Locations
Denmark
Aktivitetscenter Lynggården Recruiting
Hirtshals, Denmark, 9850
Contact: Gustav VB Sørensen, MD         
Aktivitetscenter Vesterlund Recruiting
Hjørring, Denmark, 9800
Contact: Gustav VB Sørensen, MD         
Forsamlingsbygningen Recruiting
Hjørring, Denmark, 9800
Contact: Gustav VB Sørensen, MD         
Sundhedscenter Hjørring Recruiting
Hjørring, Denmark, 9800
Contact: Gustav VB Sørensen, MD         
Sindal Aktivitetscenter Recruiting
Sindal, Denmark, 9870
Contact: Gustav VB Sørensen, MD         
Sponsors and Collaborators
Aalborg Universitetshospital
Investigators
Study Director: Stig Andersen, MD, PhD Aalborg Universitetshospital
  Study Documents (Full-Text)

Documents provided by Gustav Valentin Blichfeldt Sørensen, Aalborg Universitetshospital:
Study Protocol  [PDF] November 4, 2018


Responsible Party: Gustav Valentin Blichfeldt Sørensen, Principal Investigator, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT03608709     History of Changes
Other Study ID Numbers: 2018-82
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gustav Valentin Blichfeldt Sørensen, Aalborg Universitetshospital:
Accidental falls
Prediction model