FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066532 [Registered on: 30/04/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ellectronic Tablet Based Communication Application ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving Communication and Satisfaction in ICU Patients on mechanical ventilation using communication aids: A Trial of a Communication-APP 
Scientific Title of Study   Efficacy of Communication APP (C-APP) on ease of communication and patient satisfaction among patients with mechanical ventilation in ICUs at a tertiary care center - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANNAPOORANI M 
Designation  PhD Scholar(Nursing-Full Time) 
Affiliation  SRM College of Nursing,Faculty of Medical & Health Sciences ,SRMIST. 
Address  Room No.11, Department of Nursing Research, SRM College of Nursing, SRM Institute of Science and Technology (SRMIST), Kattankulathur Campus, Chengalpattu District.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9962947934  
Fax    
Email  anitha.siron@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C Kanniammal 
Designation  Dean cum Professor 
Affiliation  SRM College of Nursing,SRMIST. 
Address  Room No.1,Department of Medical-Surgical Nursing,SRM College of Nursing,SRM Institute OF Science and Technology(SRMIST), Kattankulathur campus,Chengalpattu District.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9500028394  
Fax    
Email  dean.nursing.ktr@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Bamini Devi N 
Designation  Professor 
Affiliation  SRM College of Nursing,SRMIST. 
Address  Room no.212,Department of Medical Surgical Nursing,SRM College of Nursing,SRM Institute OF Science and Technology(SRMIST), Kattankulathur campus,Chengalpattu District.

Kancheepuram
TAMIL NADU
603203
India 
Phone  7550034277  
Fax    
Email  baminidevi@gmail.com  
 
Source of Monetary or Material Support  
ADMINISTRATION -SRM Institute of Science and Technology -SRM Department of Medical Research,SRM College of Nursing,SRM Medical College Hospital & Research Centre,Kattankulathur,Chengalpattu District.PIN CODE-603203 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkatraman R   SRM Medical College Hospital & Research Centre.  Room No.5,Department of Anesthesiology.
Kancheepuram
TAMIL NADU 		 9894581455

drvenkat94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,SRM Medical College Hospital and Research Centre,Kattankulathur 603203,Chengalpattu District,Tamil Nadu,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z991||Dependence on respirator,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C-APP(Communication Application software) that works on electronic Tabs.(Tablets)  C-App:The C-App ICU trial aims to assess a specialized communication application designed for ICU patients on mechanical ventilation. C-App features icons (picture symbols + words/phrases) representing patient needs, wants, and queries. patients can select icons by touch that generates voice output in English or Tamil. The app operates on a bedside-mounted electronic tablet ,promoting easy accessibility. Patients will use this app from day 3 of mechanical ventilation post-randomization until their extubation or up to day 10 of ventilation. At least 10 communication exchanges are required during this period using the C-App. The trial evaluates its efficacy in improving ease of communication and patient satisfaction, potentially enhancing patient care in critical care settings.  
Comparator Agent  Communication Board.  The Communication Board is a non-electronic paper-printed board.This communication aid placed at bedside for patients on mechanical ventilation. This board features selected symbols, pictures, and words representing patient needs, wants, and queries. Patients indicate selections by pointing, enabling communication with healthcare professionals and family members in ICU settings.Patients in the control group will use the Communication Board from day 3 of mechanical ventilation post-randomization until extubation or up to day 10 of ventilation. At least 10 communication exchanges are required during this period using the communication board.This is routinely used in communication with patients on mechanical ventilator and it is available in ICU s.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of age above 18 years.
Both male and female patients
Patients who are alert, conscious, stable, and attempting to communicate.
Patients on mechanical ventilator (day 3 to 2 weeks)
Patients who are willing to participate
Patients who can read/write/understand English/Tamil
 
 
ExclusionCriteria 
Details  Patients with dementia, delirium, psychiatric disorders
Patients who have difficulty to understand and follow instructions.
Patients whose condition is hemodynamically unstable
Patients with severe hearing, visual which cannot be corrected with aids.
Patients with preexisting communication impairment such as conditions affecting speech articulation, language comprehension, or expression, including aphasia, dysarthria, or language disorders.
Patients on paralytic drugs.
Patients on CMV(Continuous Mandatory Ventilation) Mode 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Ease of Communication
2.Patient satisfaction about Communication Aid 		 1.Ease of communication
Baseline/Pretest:Assessment will be conducted on day 3 of mechanical ventilation after randomization.
Post test: Assessments will be conducted daily from day 4 upto day 10 of mechanical ventilation according to duration of ventilation,example patient on ventilation for 10 days post test will be done on day 4, day 5, day 6, day 7, day 8, day 9, and day 10.
2. Patient Satisfaction (Post test only)This assessment will be done on day 1 or 2 after extubation/tracheostomy. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Physiological Parameters(Heart rate,Blood Pressure,Respiratory Rate,ECG and Oxygen Saturation)
 		 1.Baseline before communication intervention;5 minutes,10 minutes, 15 minutes and 30 minutes after communication intervention 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anitha.siron@gmail.com].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The Efficacy of Communication APP on ease of communication and patient satisfaction among patients with mechanical ventilation in Intensive care units at a tertiary care center is being investigated through a Randomized Controlled Trial

The objective of this trial is to assess the efficacy of Communication APP in improving ease of communication and patient satisfaction among ICU patients undergoing mechanical ventilation

Patients will be  randomized into experimental and control groups with the experimental group receiving Communication APP alongside routine aids while the control group receives routine aids only

 Data collection involves screening patients based on various scales such as the Glasgow Coma Scale and Richmond Agitation Sedation Scale

Baseline assessment includes evaluating ease of communication and physiological parameters like heart rate and blood pressure

During the intervention period a minimum of 10 communication exchanges are facilitated using Communication APP or routine aids

Post-test evaluation occurs 2 to 48 hours post extubation or tracheostomy that includes assessing ease of communication and patient satisfaction

Continuous physiological monitoring of vital signs is conducted before then during and after each communication exchange

Primary outcomes focus on communication ease and patient satisfaction with secondary outcomes examining physiological responses

 
Close