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

NCT03608709 | Completed

• 1 other identifier: 2018-82
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 5

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

Conditions

Accidental Fall; Fall

Keywords

Accidental falls; Prediction model

Outcome Measures

Primary Outcomes (1)

• Number of falls

  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

  1 year follow up

Secondary Outcomes (2)

• Time consumption for the final prediction model

  After 6 months

• Arrhythmias

  After 1 year

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Community-dwelling older adults
• years old or above

You may not qualify if:

• Unable to understand Danish evaluated by the data collectors.
• Diagnosed with dementia.
• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (5)

Aktivitetscenter Lynggården

Hirtshals, 9850, Denmark

Location

Aktivitetscenter Vesterlund

Hjørring, 9800, Denmark

Location

Forsamlingsbygningen

Hjørring, 9800, Denmark

Location

Sundhedscenter Hjørring

Hjørring, 9800, Denmark

Location

Sindal Aktivitetscenter

Sindal, 9870, Denmark

Location

Related Publications (1)

• Gade GV, Jorgensen MG, Ryg J, Masud T, Jakobsen LH, Andersen S. Development of a multivariable prognostic PREdiction model for 1-year risk of FALLing in a cohort of community-dwelling older adults aged 75 years and above (PREFALL). BMC Geriatr. 2021 Jun 30;21(1):402. doi: 10.1186/s12877-021-02346-z.

  PMID: 34193084 DERIVED

Study Officials

• Stig Andersen, MD, PhD

  Aalborg University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: August 1, 2018
• Study Start: June 14, 2018
• Primary Completion: July 18, 2020
• Study Completion: July 18, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)