- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414563
Effectiveness of an Web Application in Enhancing Informal Caregivers' Nasogastric Tube Feeding Competency
Effectiveness of an Nasogastric Web Application in Reducing Time to Achieve Nasogastric Tube Feeding Competency Among Informal Caregivers
The goal of this trial is to determine whether adding a nasogastric tube web application to standard face-to-face caregiver training helps informal caregivers learn nasogastric tube feeding more quickly than standard training alone.
The main question is:
Does the use of a nasogastric tube web application alongside standard face-to-face caregiver training shorten the time required for caregivers to learn nasogastric tube feeding, compared with standard training alone?
Researchers will compare two groups: caregivers who receive standard face-to-face training plus access to the web application and caregivers who only receive standard face-to-face training to see who will learn nasogastric tube feeding more quickly.
Participants will:
- Receive either standard face-to-face training plus the web application or standard face-to-face training alone when identified for nasogastric tube feeding training.
- Have their time taken to learn nasogastric tube feeding recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nasogastric tube feeding is a technically-demanding procedure that requires both practical skill and sound clinical judgement to avoid potentially serious complications. It is therefore essential that caregivers receive adequate training to perform this task safely and effectively. Evidence suggests that digital caregiver training interventions-particularly those that include simulation-based learning and multimodal audio-visual content-can improve caregiver skills in learning and performing procedures such as nasogastric tube feeding. However, the effectiveness of a web application in improving informal caregivers' ability to perform nasogastric tube feeding has not yet been evaluated.
Assessing the usefulness of this web application may help improve existing training methods and technological supports for caregivers, enhance the quality of home-based care, strengthen continuity of care between hospital and home settings, and reduce unnecessary healthcare use.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore
- Nursing Implementation, Translation & Research Office (NITRO); Tan Tock Seng Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Caregivers who will receive standard face-to-face training
Inclusion Criteria:
- Individual who has been identified by the healthcare team to undergo caregiver training for nasogastric feeding to assist a patient with nutritional needs.
- No prior training or experience in nasogastric feeding.
- Potentially able to complete course of caregiver training for nasogastric feeding in the hospital of enrolment.
- Aged 21 and above.
Exclusion Criteria:
- Caregivers who are cognitively impaired.
- Have received prior training for nasogastric feeding.
- Will not be able to complete their course of caregiving training for nasogastric feeding in the hospital of enrolment.
Caregivers who will receive standard face-to-face training plus access to the web application
Inclusion Criteria:
- Individual who has been identified by the healthcare team to undergo caregiver training for nasogastric feeding to assist a patient with nutritional needs.
- No prior training or experience in nasogastric feeding.
- Potentially able to complete course of caregiver training for nasogastric feeding in the hospital of enrolment.
- Have the basic literacy skills to use the nasogastric tube web application.
- Able to access and use the nasogastric web application over the course of their training in nasogastric tube feeding to support their learning.
- Aged 21 and above.
Exclusion Criteria:
- Caregivers who are cognitively impaired.
- Have received prior training for nasogastric feeding.
- Will not be able to complete their course of caregiving training for nasogastric feeding in the hospital of enrolment.
- Have no or limited literacy ability to use the nasogastric web application
- Unable to access and use the nasogastric web application over the course of their training in nasogastric tube feeding.
Patients
Inclusion Criteria:
- Aged 50 years and above.
- Patient whose caregiver has been identified to undergo nasogastric tube feeding training to support their nutritional needs.
- Has mental capacity as per the approved documentation of capacity form or has a legal representative willing to provide consent to allow study team to extract medical records.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard face-to-face training
Caregivers in this arm will receive the standard face-to-face training for nasogastric tube feeding
|
|
|
Experimental: Standard face-to-face training plus access to the web application
Caregivers in this arm will receive the standard face-to-face training for nasogastric tube feeding plus access to the nasogastric tube web application to support their learning.
|
The application was co-developed with caregivers and has been content validated by multiple experts.
It can be accessed using web-enabled smart device.
The application has four main features; (1) video demonstrations; (2) micro-learning modules to build knowledge, (3) quizzes to test understanding, and (4) virtual simulation scenarios to mirror real-world scenarios for hands-on practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time taken to achieve competency
Time Frame: Through study completion, an average of 1 week
|
Time taken in hours and minutes for caregivers to achieve competency in nasogastric tube (NG) feeding
|
Through study completion, an average of 1 week
|
|
Number of training sessions to achieve competency
Time Frame: Through study completion, an average of 1 week
|
Number of training sessions taken for caregivers to competency in nasogastric tube feeding
|
Through study completion, an average of 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge of nasogastric tube feeding
Time Frame: Through study completion, an average of 1 week
|
Knowledge of nasogastric tube feeding will be measured using a self-developed Nasogastric Tube Feeding Knowledge Scale.
The scale was designed to examine caregiver understanding of nasogastric tube management.
It contains 8 items answered using a true-false format.
Each item answered correctly will receive one point.
Higher scores indicate higher caregiver knowledge.
|
Through study completion, an average of 1 week
|
|
Change in confidence in performing nasogastric tube feeding
Time Frame: Through study completion, an average of 1 week
|
Confidence in performing nasogastric tube feeding will be measured using a self-developed Perceived Confidence in Nasogastric Tube Feeding Scale.
The scale was designed to examine caregiver confidence in performing nasogastric tube feeding.
It contains 7 items rated on a 5-point scale from 0(not confident at all) to 4(very confident).
Higher scores indicate higher caregiver confidence.
|
Through study completion, an average of 1 week
|
|
Change in preparedness for caregiving
Time Frame: Through study completion, an average of 1 week
|
Preparedness for caregiving will be measured using the Preparedness for Caregiving Scale.
The scale was designed to assess how well prepared caregivers perceive they are in the various aspects of caregiving.
It contains 8 questions rated on a 5-point scale from 0(not at all prepared) to 4(very well prepared).
Higher scores indicate higher caregiver preparedness.
|
Through study completion, an average of 1 week
|
|
Caregiver acceptance of the web application as a technological training aid
Time Frame: Through study completion, an average of 1 week
|
This outcome will only be measured in caregivers in the experimental arm (standard face-to-face training plus access to the web application).
Caregiver acceptance of the web application as a technological training aid will be measured using an adapted version of the Unified Theory of Acceptance and Use of Technology (UTAUT) scale.
The scale contains 15 questions rated on a 5-point scale from 1(strongly disagree) to 5(strongly agree) in 5 domains - performance expectancy, effort expectancy, social influence, facilitating conditions and intention.
Higher scores indicate higher acceptance.
|
Through study completion, an average of 1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-1814
- CareEco21-0032 (Other Grant/Funding Number: National Innovation Challenge Grant Call on Caregiving Ecosystem)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysphagia
-
Istanbul University - CerrahpasaRecruitingDysphagia | Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationTurkey (Türkiye)
-
Morinaga Milk Industry Co., LTDHospital de MataróRecruitingDysphagia | Swallowing Disorder | Dysphagia, Oral Phase | Dysphagia, Esophageal | Dysphagia, OropharyngealSpain
-
Dongtan Sacred Heart HospitalCompleted
-
Christian SimonRecruitingDysphagia RehabilitationSwitzerland
-
University of BaghdadNot yet recruiting
-
Zhejiang Provincial People's HospitalNot yet recruitingDysphagia After Stroke
-
All India Institute of Medical Sciences, New DelhiRecruitingOropharyngeal Dysphagia | Dysphagia, Late Effect of Stroke | Transfer Dysphagia | Cricopharyngeus Muscle DysfunctionIndia
-
First Teaching Hospital of Tianjin University of...Recruiting
-
National Taiwan University HospitalRecruitingDysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationTaiwan
-
University of Southern CaliforniaRecruitingDysphagia | Pharyngeal Dysphagia | Oral Pharyngeal DysphagiaUnited States
Clinical Trials on Nasogastric tube web application
-
Rennes University HospitalCompletedPancreaticoduodenectomy | Digestive System Surgical ProcedureFrance
-
Wakayama Medical UniversityCompleted
-
National Taiwan University HospitalUnknown
-
Yale UniversityWithdrawnSmall Bowel ObstructionUnited States
-
Centre Hospitalier le MansNot yet recruitingIntubated Patient Requiring a Gastric TubeFrance
-
Cancer Institute and Hospital, Chinese Academy...Shanxi Province Cancer Hospital; Guangdong Provincial Hospital of Traditional... and other collaboratorsNot yet recruitingPancreaticoduodenectomy | Minimally Invasive Surgical Procedures | Nasogastric Tube DecompressionChina
-
University of ManitobaCompleted
-
Hamilton Health Sciences CorporationMcMaster UniversityCompleted
-
Federico II UniversityCompleted
-
Chinese University of Hong KongUnknown