SAFER Karachi - A Fall Prevention Intervention

NCT07504237 | Active Not Recruiting

• 2 other identifiers: 2025-11554-35416D43TW007292
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the adapted and strengthened fall prevention program feasible and acceptable for older adults in Karachi?
2. 2.Does participation in the program improve mobility, balance, fall-related self-efficacy, and emotional well-being among participants?
3. 3.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
4. 4.Receive a follow-up home visit to reinforce safety practices and environmental modifications
5. 5.Attend a booster session after 3 months to support continued engagement
6. 6.Complete assessments at baseline and follow-up, including mobility, cognitive function, quality of life, and emotional well-being
7. 7.Maintain monthly fall logs to report any fall incidents during the study period

Conditions

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

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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

  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

  At baseline and at the end of the intervention and follow-up (up to 6 months)

• Short-term Functional and Psychosocial Outcomes: Nutritional Status

  At baseline and at the end of the intervention and follow-up (up to 6 months)

• Short-term Functional and Psychosocial Outcomes: Sleep Quality

  At baseline and at the end of the intervention and follow-up (up to 6 months)

Other Outcomes (1)

• Fall Incidence

  Monthly during follow-up (up to 6 months)

Study Arms (1)

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.

Behavioral: Stepping On Fall Prevention Program

Interventions

Stepping On Fall Prevention Program BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Older adults, aged 60 years and above, residing in urban Karachi

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (2)

• Stepping On Program, https://www.steppingon.com/

  BACKGROUND

• 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.

  PMID: 32695497 BACKGROUND

Study Officials

• Sonia Sameen, MSc.

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 31, 2026
• Study Start: September 1, 2025
• Primary Completion: June 30, 2026
• Study Completion: July 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for up to 3 years.
• Access Criteria: Access will be granted to researchers with a methodologically sound proposal. Requests should be directed to the principal investigator and will be reviewed based on scientific merit, ethical considerations, and feasibility.

Locations

PA (1)