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.
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
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
- Conditions
- Fall, Fall Injury, Aging, Aged, Medication
- 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.
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.
- First posted27 Dec 2021
- Study start14 Jun 2018
- Primary completion18 Jul 2020
- Study completion18 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Valentin Blichfeldt Sørensen, Aalborg University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Fall Risk Increasing Drugs and Falls in Community-dwelling Older Adults: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05169476
- Acronym / sponsor ID
- 20155750
- Conditions
- Fall, Fall Injury, Aging, Aged, Medication
- Keywords
- Older adults, Accidental falls, Fall-risk increasing drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Community-dwelling older adults
- 75 years old or above
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
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.