NCT05169476

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

2.1 years

First QC Date

December 10, 2021

Last Update Submit

December 23, 2021

Conditions

Keywords

Older adultsAccidental fallsFall-risk increasing drugs

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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. 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 27, 2021

Study Start

June 14, 2018

Primary Completion

July 18, 2020

Study Completion

July 18, 2020

Last Updated

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations