NCT07504237

SAFER Karachi - A Fall Prevention Intervention

SAFER Karachi: Strengthening an Adapted Fall Prevention Intervention for Resilience in Older Adults - A Pilot Study in Karachi

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot study is to evaluate the feasibility, acceptability, and short-term effects of a culturally adapted and strengthened fall prevention program in older adults aged 60 years and above living in urban Karachi, Pakistan. The study aims to understand whether a structured, community-based intervention can improve mobility, confidence, and overall well-being, while reducing the risk of falls. The main questions it aims to answer are: 1. Is the adapted and strengthened fall prevention program feasible and acceptable for older adults in Karachi? 2. Does participation in the program improve mobility, balance, fall-related self-efficacy, and emotional well-being among participants? Participants will: 1. Take part in a 7-week group-based fall prevention program that includes strength and balance exercises, home safety education, medication awareness, and behavioural strategies 2. Receive a follow-up home visit to reinforce safety practices and environmental modifications 3. Attend a booster session after 3 months to support continued engagement 4. Complete assessments at baseline and follow-up, including mobility, cognitive function, quality of life, and emotional well-being 5. Maintain monthly fall logs to report any fall incidents during the study period

Detailed description

Falls are a major public health concern among older adults and are a leading cause of injury, disability, and loss of independence worldwide. The burden is particularly high in low- and middle-income countries (LMICs), where over 80% of fall-related deaths occur. In Pakistan, and especially in urban settings like Karachi, older adults face compounded risks due to limited access to geriatric care, inadequate home safety infrastructure, financial constraints, and reliance on informal caregiving systems. Despite this growing burden, fall prevention remains underexplored and under-implemented in the local context. Most evidence-based fall prevention interventions have been developed and tested in high-income countries, raising concerns about their applicability in LMIC settings due to differences in environmental conditions, health system structures, cultural norms, and resource availability. There is a critical need to adapt and evaluate such interventions to ensure they are feasible, acceptable, and effective within the local context. The SAFER Karachi study (Strengthening an Adapted Fall Prevention Intervention for Resilience in Older Adults) is a pilot quasi-experimental study designed to address this gap. The study aims to adapt, strengthen, and evaluate a culturally relevant fall prevention intervention for community-dwelling older adults aged 60 years and above in urban Karachi. The intervention is based on the evidence-based Stepping On program, a multi-component fall prevention strategy that integrates strength and balance training, environmental safety education, medication awareness, and behavioural change approaches to improve self-efficacy and reduce fall risk. While the core structure of the program will be retained, context-specific adaptations and strengthening measures will be incorporated to enhance feasibility, safety, and relevance in a low-resource urban setting. These include standardized facilitator training, physiotherapist-informed delivery of exercise components, integration of supportive tools to improve adherence, and minor refinements informed by formative research and local implementation considerations. The study will use a pre-test and post-test quasi-experimental design and will enroll approximately 50 older adults from selected urban communities in Karachi. The intervention will be delivered over a 7-week period through structured group sessions led by trained facilitators. Each session will focus on key components of fall prevention, including physical exercises, home hazard identification, medication-related risk awareness, vision and footwear considerations, and behavioural strategies to support long-term adherence. Peer interaction and social support will be emphasized to enhance engagement and sustainability. Following the core intervention, participants will receive a home visit to reinforce behavioural changes and environmental modifications, as well as a booster session to support continued engagement and retention of key practices. The primary focus of this pilot study is to assess the feasibility and acceptability of implementing the adapted intervention in Karachi's urban community settings. Feasibility will be evaluated through indicators such as recruitment rates, retention, session attendance, and adherence to intervention components. Acceptability will be assessed through participant feedback, qualitative interviews, and facilitator observations, providing insights into user experience and implementation challenges. In addition, the study will assess short-term changes in selected health and functional outcomes, including mobility and balance, fall-related self-efficacy, cognitive function, emotional well-being, nutritional status, sleep quality, and overall quality of life. Participants will also maintain monthly fall logs to document fall occurrences, providing preliminary data to inform future research, although the study is not powered to detect long-term reductions in fall incidence. Data collection will include baseline and follow-up assessments using standardized and validated tools, as well as qualitative interviews to explore participant experiences, barriers, facilitators, and recommendations for improvement. These findings will be used to further refine the intervention and enhance its contextual fit. This pilot study is designed to generate critical preliminary evidence to inform a larger, fully powered trial. By identifying key implementation challenges, participant engagement patterns, and early outcome trends, the study will contribute to the development of a scalable, culturally appropriate fall prevention model for Pakistan and similar LMIC settings. Ultimately, the SAFER Karachi study seeks to shift the focus from reactive management of fall-related injuries to proactive, community-based prevention strategies. By improving mobility, confidence, and overall well-being among older adults, this intervention has the potential to enhance independence and quality of life while reducing the burden on families and health systems.

Conditions

• Accidental Falls
• Falls
• Falls Injury
• Mobility Difficulty
• Mobility and Independence
• Aged 60 Years or Older

Interventions

Type	Name	Description
BEHAVIORAL	Stepping On Fall Prevention Program	This intervention is a culturally adapted and contextually strengthened version of the evidence-based Stepping On fall prevention program, tailored for older adults in a low-resource urban setting. Unlike standard implementations, this version incorporates context-specific modifications based on local environmental, social, and health system realities in Karachi. Key distinguishing features include structured facilitator training to ensure standardized delivery, physiotherapist-informed guidance for exercise components to enhance safety, and integration of supportive tools to improve participant adherence and engagement. The intervention also includes follow-up reinforcement through home visits and a booster session to support sustained behaviour change. These adaptations are designed to improve feasibility, acceptability, and scalability of the intervention within resource-constrained settings while retaining the core evidence-based components of the original program.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: Pakistan