| CTRI Number |
CTRI/2024/05/067882 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FACE TO FACE AND VIDEO BASED EDUCATION ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Care from hospital to home is good for patients |
|
Scientific Title of Study
|
A Randomized Control Trial to assess the Effectiveness of Patient Centred Transitional Care Model (PCTCM) on Self efficacy, Health Literacy and Adherence to Treatment (SeHAt) of Patients who underwent Valve Replacement Surgery at AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karuppanasamy.V |
| Designation |
M.Sc Nursing (Cardiological/CTVS Nursing |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing,Near Old OT Block,AIIMS,Ansari Nagar, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9643294737 |
| Fax |
|
| Email |
candidaalbicans5653@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing,Room No 2, Second Floor,Porta Cabin,Near Old OT Block,AIIMS,Ansari Nagar,New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing,Room No 2, Second Floor,Porta Cabin,Near Old OT Block,AIIMS,Ansari Nagar,New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| College Of Nursing, AIIMS, New Delhi, India, Pin Code-110029. |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
College of Nursing, Near Old OT Block, AIIMS, Ansari Nagar, New Delhi, India, Pin Code-110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRShashi Mawar |
AIIMS New Delhi |
Room No-1,Porta Cabin, Second Floor, College Of Nursing, Near Old OT Block, AIIMS, Ansari Nagar, New Delhi.
New Delhi
DELHI |
8800228317
drshashimawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I088||Other rheumatic multiple valve diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patient Centered Transitional Care Model (PCTCM) |
Demographic, clinical information and pre test at baseline. Implementation of PCTCM at baseline for experimental group.
Follow up at 1 week and 4 weeks with post test.
The subjects in the control group will be followed at same timeline with standard treatment.
|
| Intervention |
Patient Centred Transitional Care Model (PCTCM) |
PATIENT CENTRED TRANSITIONAL CARE MODEL(PCTCM) The intervention includes PCTC Model there are following components of this model
Disease condition and surgery details
Activity, Rest and sleep
Nutrition and Tips
Follow-up
The PCTC MODEL will be administered using multimedia approach such as videos pamphlets and flash cards. Intervention will include face to face interaction with the patient and explanation of disease condition as well as do’s and don’ts after surgery, demonstration on physical activities, post operative exercises, dietary counselling, emphasis on medication adherence, dietary restriction and compliance to lab investigations. The intervention will be given 2-3 days before discharge (the transition phase) and further reinforced on the day of discharge and subsequent follow-up visits (7-10 days).
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Post operative patients
1.Who underwent valve replacement and getting discharged after valvular heart surgery.
2.Age between 18-65 years
3.Willing to participate in study
4.Can communicate in Hindi and English
|
|
| ExclusionCriteria |
| Details |
Patients who are hemodynamically unstable. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved Self Efficacy, Health Literacy and Adherence to treatment (SEHAT) among patients who underwent valve replacement surgery |
2-3 days before discharge
On the day of discharge
on the first follow up (7-10 days after discharge)
4 weeks after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compliance & Satisfaction of PCTCM among Post Valve Replacement Patients |
4 weeks after the discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
study title: A randomized control trial to assess the effectiveness of the patient centered transitional care model (PCTCM) on self efficacy, health literacy and adherence treatment (SeHAt) of patients who underwent valve replacement surgery at AIIMS New delhi. need of the study: many patients are risk of acquiring pneumonia, surgical site infections, thrombo-embolic events after surgery, lack in the necessary information about aftercare, so development of PCTC MODEL IS essential to improve the quality of life of the patients. Aim: Improvement on self efficacy, health literacy, adherence to treatment among post valve replacement surgical patients method: A Randomized control Trial Sample size: 25 in each group (control and experimental ) Intervention: face to face interaction , PCTC MODEL will be administered using multimedia approach by videos, pamphlets, flashcards. outcome tools: self efficacy 5 point Likert scale, health literacy questionnaire, adherence to treatment 5 point Likert scale |