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FallNCT05169476

FRIDs and Fall Risk Among Older Adults

An observational study of Fall and Fall Injury, run by Aalborg University Hospital at 5 sites in Denmark.

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

The European Geriatric Medicine Society (EuGMS) Task and Finish Group published a consensus paper on fall-risk increasing drugs. However, the group did not reach consensus on 17 medication classes as potential FRIDs. Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
Conditions the study is for
Fall, Fall Injury, Aging
How many people
241 participants
Where
5 sitesDenmark
Study dates
14 Jun 2018to 18 Jul 2020
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 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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. 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.

Who may be able to join

  • Community-dwelling older adults
  • 75 years old or above

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites
  • Aktivitetscenter Lynggården

    Hirtshals, 9850

  • Aktivitetscenter Vesterlund

    Hjørring, 9800

  • Forsamlingsbygningen

    Hjørring, 9800

  • Sundhedscenter Hjørring

    Hjørring, 9800

  • Sindal aktivitetscenter

    Sindal, 9870

Other trials in Denmark

About this study

Official title: Potential Fall Risk Increasing Drugs and Falls in Community-dwelling Older Adults: A Prospective Cohort Study

The European Geriatric Medicine Society (EuGMS) Task and Finish Group published a consensus paper on fall-risk increasing drugs. However, the group did not reach consensus on 17 medication classes as potential FRIDs. Thus, in this study the investigators want to examine the association between use of these potential FRIDs and falls rate with a 1-year follow-up in a cohort of community-dwelling older adults, aged 75 years or more.

Read the detailed description

Falls in community-dwelling older adults are the most frequent cause of injury. Every year, 30% of the adults over the age of 65 years fall increasing to 32-42% among those aged ≥ 75 years. Most falls have a multifactorial aetiology such as previous falls, advanced age, cognitive impair-ment, environmental risks, and hazardous activities, along with presence of chronic disease, muscle weakness, gait and balance disorders, and medication use Especially the use of fall-risk-increasing drugs (FRIDs) is a prominent risk factor.

Recently, The European Geriatric Medicine Society (EuGMS) Task and Finish Group published a consensus paper classifying 14 medication classes as fall-risk-increasing drug (FRID) (14). Most of them were psychotropics, but several new possible FRIDs were identified. However, the group did not reach consensus on 17 medication classes as potential FRIDs.

Therefore, to achieve a better understanding of these 17 medication classes as potential FRIDs, more studies taking these issues into account are warranted.

Primary objective:

To examine the association between use of the potential FRIDs and falls rate with a 1-year follow-up in a cohort of community-dwelling older adults, aged 75 years or more.

Study design and sample:

A prospective cohort study with 1-year follow-up will be performed in collaboration with the municipality of Hjørring, Denmark. The sample size was derived without a recommended power calculation; hence, the sample size builds on feasible recruitment within the 13 months inclusion period granted by the municipality due to economical and administrative reasons.

Study setting, participants, data collectors, process of recruitment and data collection:

According to Danish legislation on health and social services, Danish municipalities are responsible for developing and initiating prophylactic and health-promoting initiatives for their senior citizens. This is done through different authorities in the municipality (e.g. preventive-home-visits, senior activity centres). Also, the municipality of Hjørring administers a local hall for citizens together with general- and patient associations. Therefore, data collection will be performed in participants' own homes through preventive-home-visits, at senior activity centres and at the local hall in the municipality of Hjørring, Denmark.

Baseline characteristics:

Data collection was performed at baseline and based on a multifactorial falls risk test battery in-cluding various physical tests (static balance under dual-task conditions, grip- and lower limb strength, reaction time of lower limbs and gait speed); self-report questionnaire on sociodemo-graphic characteristics, frailty, nutrition, disability, fear of falling, health-related quality of life, depressive symptoms, several physical symptoms, cognitive tests; and reporting of comorbidities (23). The participants' comorbidities were obtained from the participants' hospital records and the diagnoses were indexed according to the International Classification of Diseases 10th revision (ICD-10).

Baseline medication:

To determine the participants' medications at inclusion, the investigators consulted the national Shared Medica-tion Record (SMR). The SMR is a national registry of current medication use and pharmacy rec-ords of prescriptions to each citizen in Denmark. Any physician involved in the patients' clinical course has access to the SMR data and all details of each prescription and the date of the latest medication reconciliation are provided (24). For each participant all medication registered in SMR at baseline was documented and indexed according to the WHO-recommended anatomical therapeutic chemical (ATC) medication classification system.

Confounding covariates:

Many different risk factors and predictors for falls in older adults have been described previously. All these risk factors are possible confounders to the potential FRIDS; hence, the following a priori list specifies the confounding variables to be adjusted for in the multivariate regression model:

  • Age
  • Sex
  • History of previous falls
  • The comorbidity related to the potential FRID to adjust for confounding by indication
  • Fear of falling using Short Falls Efficacy Scale-International 7-item
  • Gait speed measured with a 4-meter walk test
  • Cognitive impairment estimated by the Orientation-Memory-Concentration test per-formed over the telephone
  • Frailty using the Tilburg Frailty Indicator
  • Physical and instrumental disability in activities of daily living using the Vulnerable El-ders Survey 13 .
  • Depressive symptoms using Geriatric Depression Scale 4 item, a depression diagnosis or prescription of any antidepressants
  • Use of benzodiazepines, benzodiazepines derivatives or non-benzodiazepines (Z-drugs)
  • Use of opioids
Keywords
Older adults, Accidental falls, Fall-risk increasing drugs

What is being measured

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

  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

    Measured: 1-year follow-up

Timeline

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

  1. First posted27 Dec 2021
  2. Study start14 Jun 2018
  3. Primary completion18 Jul 2020
  4. Study completion18 Jul 2020

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
Cohort
Time perspective
Prospective
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169476
Sponsor's protocol ID
20155750
Status last verified
Dec 2021
First submitted
10 Dec 2021
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fall and Fall Injury, run by Aalborg University Hospital at 5 sites in Denmark.

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 2 inclusion and 4 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. 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 falls (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Jan 2022.

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