| CTRI Number |
CTRI/2025/09/094652 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [other (specify)effectiveness of Transitional care Program] |
| Study Design |
Other |
|
Public Title of Study
|
A study to test whether a special care program can reduce depression, anxiety and stress in patients waiting for heart bypass surgery. |
|
Scientific Title of Study
|
The effectiveness of transitional care program on alleviating depression, anxiety, stress and to enhance cardiac self-efficacy among patients awaiting for elective coronary artery bypass graft. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reena Rani |
| Designation |
PhD Scholar |
| Affiliation |
KAHER Institute of Nursing Science, Belagavi |
| Address |
Reena Rani full time PhD scholar Faculty of Nursing
KAHER Institute of Nursing Science, Belagavi
Belgaum
KARNATAKA
591124
India |
| Phone |
08708080683 |
| Fax |
- |
| Email |
mannsehray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. Preeti Bhupali |
| Designation |
Vice Principal |
| Affiliation |
KLE University, Belagavi |
| Address |
Room No. 4 KLE University college of Nursing Science. Dr. Prabhakar Kore Basic Medical Science Building Near KLE Hospital and Medical Research Centre Belagavi-590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448526697 |
| Fax |
- |
| Email |
Preetirb7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reena Rani |
| Designation |
PhD Scholar |
| Affiliation |
KAHER Institute of Nursing Science, Belagavi |
| Address |
Reena Rani full time PhD scholar Faculty of Nursing
KAHER Institute of Nursing Science, Belagavi
Belgaum
KARNATAKA
591124
India |
| Phone |
08708080683 |
| Fax |
- |
| Email |
mannsehray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute/Hospital Name: KLES Dr. Prabhakar Kore Hospital & Medical Research Centre.: The Institute provides infrastructure support, including access to patient records, and clinical facilities. ADDRESS: KLES Dr. Prabhakar Kore Hospital & Medical Research Centre Front Entrance, NH Service Road, Nehru Nagar, Belagavi, Karnataka – 590010, India |
|
|
Primary Sponsor
|
| Name |
Reena Rani |
| Address |
KLE University, College of Nursing KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
Front Entrance, NH Service Road, Nehru Nagar, Belagavi, Karnataka – 590010, India |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Reena Rani |
KAHER Institute of Nursing Science, Belagavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPreeti Bhupali |
Dr Prabhakar Kore Tertiary Care Hospital, Belagavi |
Room no-55 KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
Front Entrance, NH Service Road, Nehru Nagar, Belagavi, Karnataka – 590010, India
Belgaum
KARNATAKA |
09448526697
-
Preetirb7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethics Committee on Human Subject |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable (single arm study) |
Not Applicable (single arm study) |
| Intervention |
Transitional Cae Program. |
The Transitional Care Program will be delivered during hospital stay and reinforced through follow-up contacts up to 3 months. Assessments will be done at 1 week, 1 month and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient above 18 years of age.
Patient who are willing to participate in the study.
Patient who are present during the time of data collection.
Patient who are able to communicate and no disabilities like -speech or hearing problem. |
|
| ExclusionCriteria |
| Details |
Patient who are critical ill. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Depression, anxiety and stress – measured using DASS-21 scale at baseline (pre-intervention), immediately post-intervention, 1 week, 1 month and 3 months follow-up.
2.Cardiac self-efficacy – measured using Cardiac Self-Efficacy Scale at baseline, immediately post-intervention, 1 week, 1 month and 3 months follow-up. |
immediately post-intervention, 1 week, 1 month and 3 months follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life, physical activity, and alleviating anxiety, depression, stress and to enhance cardiac self efficacy among patient who are awaiting for elective coronary artery bypass surgery in Tertiary care hospital, Belagavi. |
Follow-ups on 1week, 1 month,3 months. |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
30/09/2025 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
“Patients awaiting or undergoing coronary artery bypass graft (CABG) surgery often experience anxiety, depression, stress and reduced confidence in managing their heart condition. Transitional care programs, which provide education, counseling and follow-up support, may help improve recovery and self-care ability. The purpose of this study is to evaluate the effectiveness of a transitional care program in reducing depression, anxiety and stress, and in enhancing cardiac self-efficacy among CABG patients.” |