Pictographic Education Handout on Tracheostomy Care

Develop a Pictographic Educational Handouts and Validate Its Preliminary Efficacy on Tracheostomy Care

The goal of the study is to address the clinical problem of poor education outcome from the current practice of teaching tracheostomy care by providing them with a pictographic education handout to assist their learning. The study seeks to establish face validity and preliminary efficacy of a pictographic education handout with patients and identify factors associated with lower self-efficacy level on tracheostomy care.

Study Overview

• Status: Completed
• Conditions: Health Literacy
• Intervention / Treatment: Other: Pictographic tracheostomy care handouts

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University Frances Payne Bolton School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Had a tracheostomy as part of head and neck cancer treatment, and who is not on mechanical ventilation
• His or her date of the related tracheostomy surgery was within the past 6 months
• Have received the discharge tracheostomy care education from the clinical nurse

Exclusion Criteria:

• Documented major physical or cognitive disabilities that would limit the ability to give informed consent or answer survey questions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pictographic group; Participants received the pictographic handouts on tracheostomy care	Other: Pictographic tracheostomy care handouts; The handouts were developed and validated by Clinical and inter-professional experts based on the hospital's text-based tracheostomy home care instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Author-developed self-efficacy on tracheostomy care scale	Participants' self-reported confidence on tracheostomy care from 0 to 10 (0="not confident", 10="very confident")	immediately after consenting and post intervention (up to 2 weeks) on study survey

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: University Hospitals Seidman Cancer Center; Sigma Theta Tau International Honor Society of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: participatory action research; tracheostomy care
• Other Study ID Numbers: Pictograph_2021_STTI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No