Accidental FallsSAFERNCT07504237
SAFER Karachi - A Fall Prevention Intervention
A study testing Stepping On Fall Prevention Program in people with Accidental Falls and Falls, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Falls, Falls Injury
- What is being tested?
- Stepping On Fall Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults, aged 60 years and above, residing in urban Karachi
Who cannot join
- Individuals who rely on assistive devices for mobility
- Individuals who are bedbound or homebound and require full-time assistance
- Individuals with diagnosed cognitive impairment or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAFER Karachi: Strengthening an Adapted Fall Prevention Intervention for Resilience in Older Adults - A Pilot Study in Karachi
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:
Read more
- Is the adapted and strengthened fall prevention program feasible and acceptable for older adults in Karachi?
- Does participation in the program improve mobility, balance, fall-related self-efficacy, and emotional well-being among participants?
Participants will:
- 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
- Receive a follow-up home visit to reinforce safety practices and environmental modifications
- Attend a booster session after 3 months to support continued engagement
- Complete assessments at baseline and follow-up, including mobility, cognitive function, quality of life, and emotional well-being
- Maintain monthly fall logs to report any fall incidents during the study period
Read the 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
- Being tested
- Stepping On Fall Prevention Program
- Keywords
- Fall Prevention, Accidental Falls, Older Adults, Aging Population, Geriatric, Balance Training, Mobility, Community-Based Intervention, Stepping On Program, Feasibility Study, Quasi-Experimental Study, Urban Health, Pakistan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping On Fall Prevention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive a 7-week group-based fall prevention intervention adapted for the local context. The program focuses on improving strength, balance, and safety awareness among older adults, with additional follow-up through a home visit and booster session to support sustained behaviour change. Receives: Behavioral: Stepping On Fall Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Adapted Fall Prevention Intervention: Recruitment Rate
Proportion of eligible participants enrolled in the study. Expressed as a percentage (0-100%), with higher values indicating better feasibility.
Measured: From baseline to the end of recruitment (up to 2 months)
Feasibility of the Adapted Fall Prevention Intervention: Retention Rate
Proportion of enrolled participants who complete the study. Expressed as a percentage (0-100%), with higher values indicating better feasibility.
Measured: From baseline to the end of the intervention and follow-up (up to 6 months)
Feasibility of the Adapted Fall Prevention Intervention: Session Attendance
Number or proportion of intervention sessions attended by participants. Reported as a percentage or count, with higher values indicating better adherence.
Measured: From baseline to the end of the intervention and follow-up (up to 6 months)
Feasibility of the Adapted Fall Prevention Intervention: Adherence to Intervention
Extent to which participants follow prescribed intervention components. Reported as a proportion or score, with higher values indicating better adherence.
Measured: From baseline to the end of intervention and follow-up (up to 6 months)
Acceptability of the Adapted Fall Prevention Intervention: Acceptability Score
Measured using a Likert-scale questionnaire (e.g., 1-5), where higher scores indicate greater acceptability of the intervention.
Measured: From baseline to the end of the intervention anf follow-up (up to 6 months)
Acceptability of the Adapted Fall Prevention Intervention: Participant Experience (Qualitative)
Assessed through qualitative interviews exploring participant experiences and perceptions of the intervention. Data will be analyzed thematically.
Measured: At the end of the intervention and follow-up (up to 1 month)
Acceptability of the Adapted Fall Prevention Intervention: Facilitator Evaluation
Facilitator-reported acceptability will be assessed using a structured questionnaire adapted from the Acceptability of Intervention Measure (AIM), a validated 4-item scale evaluating appropriateness, satisfaction, appeal, and willingness to continue. Items are rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). A mean score (range: 1-5) will be calculated, with higher scores indicating greater acceptability.
In addition, facilitators will complete a Structured Intervention Delivery Assessment Checklist covering ease of delivery, fidelity, and participant engagement. Items will be rated on a 5-point Likert scale (1 = poor/not at all to 5 = excellent/to a great extent). Mean domain and overall scores (range: 1-5) will be calculated, with higher scores indicating better implementation. Responses will be summarized descriptively.
Measured: At the end of the intervention and follow-up (up to 1 month)
Secondary outcomes (9)
Short-term Functional and Psychosocial Outcomes: Activities of Daily Living (ADL)
Assessed using the Katz Index of Independence in Activities of Daily Living. Scores range from 0 to 6, with higher scores indicating greater independence.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Fall-Related Self-Efficacy
Measured using the Modified Falls Efficacy Scale. Scores range from 0 to 10 (or tool-specific range), with higher scores indicating greater confidence in performing activities without falling.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Mobility and Balance
Assessed using the Timed Up and Go (TUG) test. Performance is measured in seconds, with shorter times indicating better mobility and balance.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Nutritional Status
Measured using the Mini Nutritional Assessment (MNA). Scores range from 0 to 30, with higher scores indicating better nutritional status.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Sleep Quality
Assessed using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Quality of Life
Measured using the World Health Organization Quality of Life - BREF (WHOQOL-BREF). Domain scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Cognitive Function
Assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Emotional Well-being
Measured using the Kessler Psychological Distress Scale (K10). Scores range from 10 to 50, with higher scores indicating greater psychological distress.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Short-term Functional and Psychosocial Outcomes: Adherence to Safety Modifications
Adherence to recommended home and community safety modifications will be assessed using a structured Self-Reported Safety Modification Adherence Checklist developed for this study based on standard fall prevention guidelines from multiple sources, including the Otago guidelines, WHO, and more. The checklist will include multiple items covering home environment modifications, use of assistive devices, and safe mobility practices. Each item will be scored as 0 (not implemented), 1 (partially implemented), or 2 (fully implemented).
A total adherence score will be calculated by summing item responses, with scores ranging from 0 to the maximum possible based on applicable items; higher scores indicate greater adherence. Adherence may also be expressed as a proportion (%) of recommended modifications implemented.
Measured: At baseline and at the end of the intervention and follow-up (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, pre-test and post-test quasi-experimental pilot study designed to evaluate the feasibility, acceptability, and short-term effects of a culturally adapted and strengthened fall prevention intervention among older adults in urban Karachi. All participants will receive the intervention, which consists of a structured 7-week group-based program incorporating strength and balance training, environmental safety education, medication awareness, and behavioural strategies. The intervention is delivered by trained facilitators, with physiotherapist-informed guidance for exercise components to ensure safety and appropriateness for older adults. Following the core intervention, participants will receive a home visit to reinforce behavioural and environmental modifications, as well as a booster session to support sustained engagement and adherence. Outcomes will be assessed at baseline and at follow-up time points to evaluate changes within participants over time.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Sonia Sameen, Aga Khan University
- Investigators
- Sonia Sameen, MSc., Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504237
- Sponsor's protocol ID
- 2025-11554-35416
- Other IDs
- D43TW007292, 2025
- Acronym
- SAFER
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary study results and will include variables necessary to reproduce the findings. All data sharing will be subject to approval by the principal investigator and the Aga Khan University Ethics Review Committee, and will require a data sharing agreement to ensure confidentiality, ethical use, and compliance with institutional policies.
Publications
Stepping On Program, https://www.steppingon.com/
Mahoney JE, Gangnon R, Clemson L, Jaros L, Cech S, Renken J. Outcomes associated with scale-up of the Stepping On falls prevention program: A case study in redesigning for dissemination. J Clin Transl Sci. 2020 Mar 4;4(3):250-259. doi: 10.1017/cts.2020.17.
PubMed 32695497