NCT05176236

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

October 13, 2021

Last Update Submit

December 16, 2021

Conditions

Health Literacy

Keywords

tracheostomy careparticipatory action research

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pictographic group

EXPERIMENTAL

Participants received the pictographic handouts on tracheostomy care

Other: Pictographic tracheostomy care handouts

Interventions

Pictographic tracheostomy care handoutsOTHER

The handouts were developed and validated by Clinical and inter-professional experts based on the hospital's text-based tracheostomy home care instructions.

Pictographic group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University Frances Payne Bolton School of Nursing

Cleveland, Ohio, 44106, United States

Location

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
Research Fellow, Sarah Cole Hirsh Institute for Evidence Based Practice, Frances Payne Bolton School of Nursing

Study Record Dates

First Submitted

October 13, 2021

First Posted

January 4, 2022

Study Start

October 1, 2020

Primary Completion

March 30, 2021

Study Completion

May 30, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations

US(1)