NCT06984692

Brief Summary

The purpose of this study is to assess the effectiveness of a novel mHealth intervention that is being designed to promote self-efficacy and response willingness among Pakistan-based emergency department health care workers (HCWs) in public health emergencies and disasters. This application seeks approval for the trial of the intervention. The purpose of this trial is to gauge short-term (1-month), medium-term (6-months), and longer-term (12-months) impacts of iRise mHealth app on low and middle income based countries HCWs' self-efficacy and willingness to respond (WTR) during public health emergencies and disasters. The investigators will test the hypothesis that the iRise app would yield an increased 12-months WTR in Aga Khan University Hospital (AKUH) and Jinnah Postgraduate Medical Center (JMPC) emergency departments.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

May 8, 2025

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Willingness to respond (WTR) to disasters as measured by Hospital Infrastructure Response Survey Tool (HIRST)

    HIRST uses a 9-point Likert scale \[1= Strongly Agree; 9 = Strongly Disagree\] or "Don't Know) to indicate attitudes and beliefs about a series of 20 construct statements relevant to emergency response risk perception. Score range 20-180. Higher scores indicate a greater willingness to respond or preparedness.

    Baseline, 1 month, 6 months, 12 months

  • Willingness to respond (WTR) to disasters as measured by Hospital Infrastructure Response Survey Tool (HIRST)

    HIRST uses a 9-point Likert scale \[1= Strongly Agree; 9 = Strongly Disagree\] or "Don't Know) to indicate attitudes and beliefs about a series of 20 construct statements relevant to emergency response risk perception. Score range 20-180. Higher scores indicate a greater willingness to respond or preparedness.

    1 month

  • Willingness to respond (WTR) to disasters as measured by Hospital Infrastructure Response Survey Tool (HIRST)

    HIRST uses a 9-point Likert scale \[1= Strongly Agree; 9 = Strongly Disagree\] or "Don't Know) to indicate attitudes and beliefs about a series of 20 construct statements relevant to emergency response risk perception. Score range 20-180. Higher scores indicate a greater willingness to respond or preparedness.

    6 months

  • Willingness to respond (WTR) to disasters as measured by Hospital Infrastructure Response Survey Tool (HIRST)

    HIRST uses a 9-point Likert scale \[1= Strongly Agree; 9 = Strongly Disagree\] or "Don't Know) to indicate attitudes and beliefs about a series of 20 construct statements relevant to emergency response risk perception. Score range 20-180. Higher scores indicate a greater willingness to respond or preparedness.

    12 months

Secondary Outcomes (4)

  • Self efficacy as assessed by the General Self-efficacy Scale

    Baseline

  • Self efficacy as assessed by the General Self-efficacy Scale

    1 month

  • Self efficacy as assessed by the General Self-efficacy Scale

    6 months

  • Self efficacy as assessed by the General Self-efficacy Scale

    12 months

Study Arms (2)

Control Curriculum

ACTIVE COMPARATOR

Control group: The control group will receive standard training in crisis response and management, which is offered as a course on Emergency Management and Response at AKU, for which study participants from JPMC will also readily access. Participants will be able to both view and download the course content via internet and can request a printed version of the course. The course involves introduction to disaster terminology, emergency management cycle and hospital-based patient treatment guidelines. The control curriculum will offer a comprehensive focus on disaster preparedness, addressing important subjects such as emergency management techniques, disasters, and triage. The eight-hour training will be split into two parts, aiming to improve academic and practical understanding. The first part will be a didactic session, where participants will learn fundamental information through lectures and discussions. The second part will consist of hands-on training.

Other: Control Curriculum

iRise curriculum

EXPERIMENTAL

The intervention group would download the iRise mHealth app ("iRise app") via Canvas on the participant's respective smart phones, and based on the participant's own schedules and preferences, would complete different modules of iRise. The iRise app would include emergency management elements as received by the control group, but presented via smart phone-based content delivery (i.e., rather than rather than via the in-person modality utilized for the control group).

Other: iRise curriculum

Interventions

Intervention group: The intervention group would download the iRise mHealth app ("iRise app") via Canvas on the participant's respective smart phones, and based on the participant's own schedules and preferences, would complete different modules of iRise. The iRise app would include emergency management elements as received by the control group, but presented via smart phone-based content delivery (i.e., rather than rather than via the in-person modality utilized for the control group).

iRise curriculum

The control group will receive standard training in crisis response and management, which is offered as a course on Emergency Management and Response at AKU, for which study participants from JPMC will also readily access. The course involves introduction to disaster terminology, emergency management cycle and hospital-based patient treatment guidelines. The control curriculum will offer a comprehensive focus on disaster preparedness, addressing important subjects such as emergency management techniques, disasters, and triage. The eight-hour training will be split into two parts, aiming to improve academic and practical understanding. The first part will be a didactic session, where participants will learn fundamental information through lectures and discussions. The second part will consist of hands-on training, allowing attendees to practice and apply learned concepts in simulated emergency scenarios.

Control Curriculum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants are eligible to be included in the study if
  • aged 18 years or older,
  • have worked in the current job position for at least three months,
  • current Emergency Department clinical staff/employee involved in direct patient care (doctors, nurses, and technicians) at a participating institution (Aga Khan University Hospital (AKUH), Jinnah Postgraduate Medical Centre (JPMC)
  • understand and write English,
  • own a smart phone and have access to the internet to download the app.

You may not qualify if:

  • Participants will not be eligible to participate if
  • younger than 18 years of age,
  • have worked in the current job position for less than three months,
  • are not a current employee or staff member as described above,
  • are auxiliary personnel such as registration staff, housekeeping, porters, and security personnel,
  • don't understand and write English, or
  • don't own a smart phone or have access to the internet to download the app.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

Location

Aga khan university

Karachi, Sindh, Pakistan

Location

Study Officials

  • Daniel Barnett, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This will be a 12-month, two-arm, parallel randomized controlled trial to evaluate a mHealth intervention, iRise, for emergency health care workers (HCWs).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 22, 2025

Study Start

October 1, 2025

Primary Completion

April 15, 2026

Study Completion

April 30, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations