Health LiteracyNCT05176236
Pictographic Education Handout on Tracheostomy Care
A study testing Pictographic tracheostomy care handouts in people with Health Literacy, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Literacy
- What is being tested?
- Pictographic tracheostomy care handouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Documented major physical or cognitive disabilities that would limit the ability to give informed consent or answer survey questions
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University Frances Payne Bolton School of Nursing
Cleveland, Ohio, 44106
About this study
Official title: 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.
- Conditions
- Health Literacy
- Being tested
- Pictographic tracheostomy care handouts
- Keywords
- tracheostomy care, participatory action research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pictographic group | Experimental | Participants received the pictographic handouts on tracheostomy care Receives: Other: Pictographic tracheostomy care handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: immediately after consenting and post intervention (up to 2 weeks) on study survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Oct 2020
- Primary completion30 Mar 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing, University Hospitals Seidman Cancer Center
- Responsible party
- Principal investigator, Tongyao Wang, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176236
- Sponsor's protocol ID
- Pictograph_2021_STTI
- Status last verified
- Dec 2021
- First submitted
- 13 Oct 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang T, Voss JG, Schiltz N, Rezaee R, Chhabra N, Mazanec SR. Effectiveness of Pictorial Education Handout on Tracheostomy Care Self-efficacy in Patients With Head and Neck Cancer and Family Caregivers: A Pilot Quasi-Experimental Study. Cancer Nurs. 2024 Nov-Dec 01;47(6):495-504. doi: 10.1097/NCC.0000000000001237. Epub 2023 Mar 31.
PubMed 37026969
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop a Pictographic Educational Handouts and Validate Its Preliminary Efficacy on Tracheostomy Care
- ClinicalTrials.gov ID
- NCT05176236
- Acronym / sponsor ID
- Pictograph_2021_STTI
- Conditions
- Health Literacy
- Keywords
- tracheostomy care, participatory action research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing, University Hospitals Seidman Cancer Center
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pictographic group | Experimental | Other: Pictographic tracheostomy care handoutsParticipants received the pictographic handouts on tracheostomy care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Documented major physical or cognitive disabilities that would limit the ability to give informed consent or answer survey questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pictographic tracheostomy care handoutsThe handouts were developed and validated by Clinical and inter-professional experts based on the hospital's text-based tracheostomy home care instructions. | Other | Pictographic group |
Primary outcome
Author-developed self-efficacy on tracheostomy care scale
Time frame: immediately after consenting and post intervention (up to 2 weeks) on study survey
Participants' self-reported confidence on tracheostomy care from 0 to 10 (0="not confident", 10="very confident")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 37026969Wang T, Voss JG, Schiltz N, Rezaee R, Chhabra N, Mazanec SR. Effectiveness of Pictorial Education Handout on Tracheostomy Care Self-efficacy in Patients With Head and Neck Cancer and Family Caregivers: A Pilot Quasi-Experimental Study. Cancer Nurs. 2024 Nov-Dec 01;47(6):495-504. doi: 10.1097/NCC.0000000000001237. Epub 2023 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pictographic tracheostomy care handouts in people with Health Literacy, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Author-developed self-efficacy on tracheostomy care scale (time frame: immediately after consenting and post intervention (up to 2 weeks) on study survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05176236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.