NCT06204471

Brief Summary

Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

November 14, 2023

Last Update Submit

January 11, 2024

Conditions

Falls Risk

Keywords

Hip protectorAirbag

Outcome Measures

Primary Outcomes (1)

  • Acceptability and useability of a hip protector airbag, qualitative analysis

    Tolerance of, and psychosocial impact of wearing a hip protector airbag will be explored through a semi-structured in-depth interview at the end of each 2-month period of wearing the airbag. This will explore significant patterns and themes related to acceptability of each airbag through deductive interview content analysis.

    After 2 month period of wearing each airbag

Secondary Outcomes (2)

  • Acceptability and useability of a hip protector airbag, quantitative measure

    After 2 months of wearing each device.

  • Fear of falling (FoF)

    After 2 months of wearing each device

Study Arms (2)

Airbag1

EXPERIMENTAL

Airbag1 worn for two months

Device: Helite hip protectorDevice: Wolk hip protector

Airbag2

EXPERIMENTAL

Airbag2 worn for 2 months

Device: Helite hip protectorDevice: Wolk hip protector

Interventions

Helite hip protectorDEVICE

hip protector

Airbag1Airbag2
Wolk hip protectorDEVICE

Hip protectdor

Airbag1Airbag2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 65 years and older
  • or more falls in the last year requiring medical attention
  • Fear of Falling (single question Y/N)
  • Able to give informed consent

You may not qualify if:

  • Nursing home resident
  • Immobile, or requires another person to assist with transfers and mobility
  • Unable to apply or remove the hip airbag independently
  • Waist circumference \<70cm or \>125cm (Helite device is sized by waist) and
  • Hip circumference \<84cm or \>125cm (Wolk device sized by hip)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

RECRUITING

Study Officials

  • Frances Dockery, MD

    Beaumont Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Dockery, MD

CONTACT

+35318093000francesdockery@beaumont.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Pilot study of two months, then crossed over to the other for two months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

January 12, 2024

Study Start

January 2, 2024

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

IE(1)