Multi-component Intervention for Reducing Fear of Falling in Community-dwelling Older Adults

NCT05192408 | Unknown

• 1 other identifier: 2021/00742
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

In the short term, the study will provide insight into the effectiveness of multi-component intervention for reducing Fear of falling (FoF) in community-dwelling older adults. Effective interventions will be incorporated into existing programs for frailty and falls prevention in primary care. Reducing FoF will break the cycle of physical activity restriction, functional decline and further falls in older adults. Long term potential benefits include improving the health status of older adults and thus reducing healthcare utilization. The primary aim is to compare the effectiveness of a multi-component intervention comprising exercise recommendations, cognitive behavioural therapy (CBT) components and motivational interviewing (MI) based telephone review against usual care for reducing Fear of Falling (FoF) in community- dwelling older adults. Secondary aims include to compare the effectiveness of the multi-component intervention against usual care for increasing physical activity and reducing falls in community- dwelling older adults. The hypothesis is that the multi-component intervention will be more effective as compared to usual care for reducing FoF and falls and increasing physical activity in community- dwelling older adults.

Conditions

Fear of Falling

Outcome Measures

Primary Outcomes (1)

• Fear of Falling (FoF)

  FoF as measured by short FES-I

  3 months

Secondary Outcomes (2)

• Number of falls

  3 months

• Physical Activity

  3 months

Study Arms (2)

Multi-component intervention

EXPERIMENTAL

Individual intervention will comprise: 1. Cognitive- behavioral therapy (CBT) which includes: - Behavioural activation, cognitive restructuring, promotion of safety, relaxation techniques 2. Exercise recommendation utilizing current Exercise in older adults Patient Education Materials (PEMs) and videos, tailored based on frailty level and readiness to progress - Components include balance and strength 3. Use of motivational interviewing (MI) techniques for goal setting There will be 4 sessions in total. Initial sessions will be carried out face to face or via videoconferencing platform if participant prefers due to ongoing COVID-19 pandemic. Subsequent sessions will be carried out via telephone. Initial sessions will last around 30 minutes and subsequent sessions will last 15 to 30 minutes.

Behavioral: Multi-component intervention

Usual Care

OTHER

Patient Education Materials (PEMs) on: 1. Exercise in older adults (Stay Active, Stay Strong and Stay Steady) - 3 different levels tailored to frailty level and for progression 2. Falls prevention 3. FoF

Other: Usual Care

Interventions

Multi-component intervention BEHAVIORAL

Individual intervention will comprise: 1. Cognitive- behavioral therapy (CBT) which includes: - Behavioural activation, cognitive restructuring, promotion of safety, relaxation techniques 2. Exercise recommendation utilizing current Exercise in older adults Patient Education Materials (PEMs) and videos, tailored based on frailty level and readiness to progress - Components include balance and strength 3. Use of motivational interviewing (MI) techniques for goal setting There will be 4 sessions in total. Initial sessions will be carried out face to face or via videoconferencing platform if participant prefers due to ongoing COVID-19 pandemic. Subsequent sessions will be carried out via telephone.

Multi-component intervention

Usual Care OTHER

Patient Education Materials

Usual Care

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Older adults aged 65 and above
• Followed up at National Healthcare Group Polyclinics for any chronic condition
• Able to communicate in English, Mandarin, Malay
• Reports Fear of falling as screened by single question

You may not qualify if:

• Unable to agree to participation e.g., due to cognitive impairment
• Unable or unsafe to participate in any exercise as determined by clinician e.g., terminal illness, uncontrolled hypertension, immobility
• Unable to participate in telephone sessions e.g., due to hearing impairment
• Known psychiatric condition on treatment

Sponsors & Collaborators

• National Healthcare Group Polyclinics: lead

Study Sites (1)

National Healthcare Group Polyclinics

Singapore, 380130, Singapore

Location

Related Publications (1)

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and study team members who carry out intervention(nurses) will not be masked. Outcome assessors will be study team members from different clinics as participants or study team members who were not involved in intervention, and will thus be unaware of participants' allocated group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 14, 2022
• Study Start: January 3, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)