Acceptability of Hip Protector Airbags in Older People

Evaluating the Acceptability of Airbag Hip Protectors in Older People

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

Study Overview

• Status: Recruiting
• Conditions: Falls Risk
• Intervention / Treatment: Device: Helite hip protector; Device: Wolk hip protector

Detailed Description

Traditional hip protectors are specialised pads designed to shield the greater trochanter on (fall) impact. They have uncertain benefits in reducing hip fracture risk and have very poor uptake due to discomfort. Recently, airbag technology has allowed radical change in design and wearability of hip protectors. Despite these airbags being commercially available, there is little evidence of their acceptability/wearability, and as with all hip protectors, virtually no research exists in community-dwelling people. A study of traditional hip protectors found that they may reduce fear of falling (FoF) in community dwellers but activity levels or quality of life were not assessed. A non-randomised study is ongoing of hip airbags on fractures in nursing homes, but none in community dwellers. Two Hip Protectors available in Europe are CE marked as personal protective equipment and approved for sale. There is a need to evaluate their acceptability and usefulness before considering larger clinical trials evaluating their efficacy in preventing hip fractures. This study will evaluate the two hip protectors and gain patient feedback in their use.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frances Dockery, MD; Phone Number: +35318093000; Email: francesdockery@beaumont.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Beaumont Hospital
    • Contact: Frances Dockery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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

Exclusion criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airbag1; Airbag1 worn for two months	Device: Helite hip protector; hip protector; Device: Wolk hip protector; Hip protectdor
Experimental: Airbag2; Airbag2 worn for 2 months	Device: Helite hip protector; hip protector; Device: Wolk hip protector; Hip protectdor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and useability of a hip protector airbag, quantitative measure	SUS (System Usability Scale): The SUS is adapted for the purposes of this study, from similar in the literature and consists of 10 questions each uses a 10 point Likert scale rating factors such as ease of use, charging the device, appearances etc. A high score (100 max score) means highly rated, and 10 (lowest score) means poorly rated.	After 2 months of wearing each device.
Fear of falling (FoF)	FoF will be assessed using the FES1 (Falls Efficacy Scale International 1) questionnaire. This uses a 4 point scale for subjective level of concern for 16 questions related to falls and activity. Maximum scores is 64 for highest level of concern or fear of falling.	After 2 months of wearing each device

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: Beaumont Hospital
• Investigators: Principal Investigator: Frances Dockery, MD, Beaumont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hip protector; Airbag
• Other Study ID Numbers: RFCTLR 73

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: tbc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No