NCT01960738

Brief Summary

To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,116

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 7, 2013

Last Update Submit

October 9, 2013

Conditions

Keywords

DivingWaterRecreationPrecursor

Outcome Measures

Primary Outcomes (1)

  • Mishaps

    Mishaps were reported by scuba divers themselves, at the end of their diving day (the day they were enrolled). Mishaps are precursors of injuries. Injuries are less common outcomes (in fact, nobody got injured), hence we used mishaps - which allowed us to test the efficacy of pre-dive checklists, and do so with limited resources.

    One day

Secondary Outcomes (2)

  • Major mishaps

    One day

  • Minor Mishaps

    One day

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group received a pre-dive checklist and a post-dive log

Other: A pre-dive checklist

Control

NO INTERVENTION

The control group received the post-dive log only.

Interventions

The pre-dive checklist included a checklist of tasks to be undertaken before the dive, a dive-plan that asked the diver to plan the depth, and amount of gas kept at different levels of diving, and 4 dive tips.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • Having a valid Diver Certification
  • Deemed fit by the Dive operator to dive on the day of participation
  • Planning to dive on the day of participation
  • Have basic knowledge of English

You may not qualify if:

  • A diver who did not answer the outcomes questionnaire was later excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aquatic Safaris

Wilmington, North Carolina, 28403, United States

Location

Sunset House

George Town, Grand Cayman, Cayman Islands

Location

Aldora Divers

San Miguel de Cozumel, Quintana Roo, Mexico

Location

Sand Dollar Sports

San Miguel de Cozumel, Quintana Roo, Mexico

Location

Related Publications (1)

  • Ranapurwala SI, Denoble PJ, Poole C, Kucera KL, Marshall SW, Wing S. The effect of using a pre-dive checklist on the incidence of diving mishaps in recreational scuba diving: a cluster-randomized trial. Int J Epidemiol. 2016 Feb;45(1):223-31. doi: 10.1093/ije/dyv292.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Shabbar I Ranapurwala, MPH

    Research Assistant, Medical Research

    PRINCIPAL INVESTIGATOR
  • Petar J Denoble, MD, DSc

    Vice President, Medical Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 11, 2013

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations