NCT05434442

Brief Summary

The aim of this study is to determine the effects of animation-based mobile application and simulation-based training methods on tracheal aspiration knowledge and skills of patient relatives who care for patients with tracheostomy/tracheotomy. Experimental pre-test-post-test control group study design was planned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 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 3, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

June 14, 2022

Last Update Submit

November 30, 2023

Conditions

TracheostomyFamily CaregiversAspiration

Keywords

Family CaregiversTracheostomy aspirationMobile applicationSimulation training

Outcome Measures

Primary Outcomes (2)

  • To determine the effects of simulation model, mobile application and routine training methods on the knowledge scores of the caregivers of patients with tracheostomy before the training, after the training and one month after the training.

    Getting at least 50 points from each part of the "knowledge evaluation form", which includes questions about the procedure.

    through study completion, an average of 1 year

  • To determine the effects of simulation model, mobile application and routine training methods on the skill levels of caregivers of patients with tracheostomy before, after and one month after training.

    Caregivers will be evaluated according to the "skill evaluation form" during the aspiration process from the tracheostomy.

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Satisfaction with different training methods

    through study completion, an average of 1 year

  • One month after the different trainings, the effects of caregivers on the aspiration application will be evaluated using the "Results Evaluation Form".

    through study completion, an average of 1 year

Study Arms (3)

1-simulation model training

OTHER

Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator. They will also receive clinical routine training

Other: simulation model trainingOther: control group

2-mobile app training

OTHER

An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher. They will also receive clinical routine training

Other: mobile app trainingOther: control group

3-control group

OTHER

Clinical routine training will be given to caregivers in this group.

Other: control group

Interventions

simulation model trainingOTHER

Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator.

1-simulation model training
mobile app trainingOTHER

An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher.

2-mobile app training
control groupOTHER

Clinical routine training will be given to caregivers in this group.

1-simulation model training2-mobile app training3-control group

Eligibility Criteria

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

You may qualify if:

  • Being the primary caregiver of the patient who will undergo a tracheotomy or tracheostomy, which is expected to last at least one month,
  • Primary care will be continued by the same caregiver for a period of one month.
  • Volunteering to participate in the research
  • Being over 18 years old,
  • Absence of a diagnosed psychiatric illness that may interfere with communication
  • Owning and being able to use a smart mobile phone

You may not qualify if:

  • Not being the primary caregiver of the patient who will undergo tracheostomy or tracheotomy,
  • Change of primary caregiver in less than a month
  • Closing the tracheotomy in less than a month
  • Not volunteering to participate in the research
  • Be under the age of 18,
  • Having a diagnosed psychiatric illness that may interfere with communication
  • Not having or being unable to use a smart mobile phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yeliz

Bursa, Nilüfer, Turkey (Türkiye)

Location

Bursa Uludag university

Bursa, 16000, Turkey (Türkiye)

Location

Related Publications (2)

  • Bayram SB, Caliskan N. Effect of a game-based virtual reality phone application on tracheostomy care education for nursing students: A randomized controlled trial. Nurse Educ Today. 2019 Aug;79:25-31. doi: 10.1016/j.nedt.2019.05.010. Epub 2019 May 9.

    PMID: 31102793BACKGROUND

  • Loerzel VW, Crosby WW, Reising E, Sole ML. Developing the Tracheostomy Care Anxiety Relief Through Education and Support (T-CARES) Program. Clin J Oncol Nurs. 2014 Oct;18(5):522-7. doi: 10.1188/14.CJON.522-527.

    PMID: 25253106BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • yeliz Şapulu Alakan

    Uludag Universty

    PRINCIPAL INVESTIGATOR

  • Neriman Akansel

    Uludag Universty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Caregivers will be assigned to control, simulation and mobile application groups by block randomization method, and communication between groups will be controlled. Caregivers assigned to groups by block randomization method will be numbered. Skill evaluation videos will be taken by a researcher. Skill assessments will also be made by another blinded researcher to the groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Caregivers will be assigned to control, simulation and mobile application groups by block randomization method. An equal number of caregivers from each clinic will be assigned to each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 28, 2022

Study Start

June 3, 2022

Primary Completion

August 10, 2023

Study Completion

August 10, 2023

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After the research is published
Access Criteria
It will be shared by researcher Yeliz ŞAPULU ALAKAN to be used in meta analysis or other research.

Locations

TU(2)