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CTRI Number  CTRI/2024/08/072792 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Self care Intervention Program (SIP) on Self-care Behaviour, Clinical Outcome and Quality of Life among patients with Heart Failure. 
Scientific Title of Study   Effectiveness of Self care Intervention Program (SIP) on Self-care Behaviour, Clinical Outcome and Quality of Life among patients with Heart Failure- a Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MeeralakshmiG 
Designation  Assistant Professor 
Affiliation  Government College of Nursing, Government Medical College, Thiruvananthapuram. 
Address  Government College of Nursing, Medical-Surgical Nursing Dept., P.G. Block, Room No.2 Government Medical College, Thiruvananthapuram, Kerala. India.

Thiruvananthapuram
KERALA
695011
India 
Phone  9207306340  
Fax    
Email  meerapraveen08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MeeralakshmiG 
Designation  Assistant Professor 
Affiliation  Government College of Nursing, Government Medical College, Thiruvananthapuram. 
Address  Government College of Nursing, Medical-Surgical Nursing Dept., P.G.Block. Room No.2 Government Medical College, Thiruvananthapuram, Kerala. India.

Thiruvananthapuram
KERALA
695011
India 
Phone  9207306340  
Fax    
Email  meerapraveen08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meeralakshmi. G 
Designation  Assistant Professor 
Affiliation  Government College of Nursing, Government Medical College, Thiruvananthapuram. 
Address  Government College of Nursing, Medical-Surgical Nursing Dept., P.G.Block, Room No.2 Government Medical College, Thiruvananthapuram, Kerala. India.

Thiruvananthapuram
KERALA
695011
India 
Phone  9207306340  
Fax    
Email  meerapraveen08@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College Hospital, Medical College P.O. Thiruvananthapuram, Kerala, India. 
 
Primary Sponsor  
Name  MeeralakshmiG 
Address  Assistant Professor, Government College of Nursing, Thiruvananthapuram. 
Type of Sponsor  Other [self] 
 
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 Sivaprasad K  Government Medical College Hospital, Medical College P.O. Thiruvananthapuram, Kerala.  Cardiology department- ICCU1, ICCU2, ward 1,2,3 and 4.
Thiruvananthapuram
KERALA 		 9446301189

spprasadam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government College of Nursing, Thiruvananthapuram.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I508||Other heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Self-care Intervention Program (SIP) and standard treatment.  Self-care Intervention Program (SIP) is an individually tailored programme prepared based on European Society of Cardiology and American Heart Association guidelines. It includes a combination of face-to-face instruction with teach-back method on self-care with three sessions (video-assisted teaching, demonstration of monitoring body weight, a symptom and event diary, and a leaflet on self-care) and reinforcement. •Face-to-face instruction with teach-back method: This involves three sessions of one-to-one individualized tailored instruction to the patients and their caregivers on various aspects of self-care in heart failure. The first two sessions will be given on two consecutive days and the third session will be on the day of discharge. The first session will be a video-assisted teaching on various aspects of self-care in heart failure. This will take approximately 30 minutes. The components of instruction include:  an overview of heart failure  lifestyle modifications such as activity & exercise, healthy diet, fluid and salt restrictions, cessation of smoking, abstinence of alcohol  immunization with influenza & pneumococcal vaccine  symptom monitoring & early recognition of signs and symptoms of worsening heart failure; and symptom management .compliance with medications  follow-ups o During the second session, patients will be taught how to check body weight by demonstration. They will also be given a symptom and event diary to log their symptoms, body weight and frequency of readmissions. This will take approximately 15 minutes.  Symptom and event diary: It is a diary for recording symptoms, body weight, and frequency of readmissions. Patients will be instructed to monitor and record their symptoms such as shortness of breath, cough, edema, chest pain, palpitation, disturbed sleep, and decreased appetite and fatigue in the diary. They can also record the number of unplanned/ emergency hospital admissions, visits to the emergency department for exacerbation of symptoms related to heart failure, the reason for hospitalization/ emergency visit, and the duration of hospital admission if any. o During the third session (on the day of discharge), patients will be given a leaflet on HF self-care. It is a printed material containing the same information on HF self-care as in face-to face instruction for further reference. This will take approximately 10 minutes. • Reinforcement: An online support group (WhatsApp group) will be created for further reinforcement to the participants & ongoing interaction. This will be continued for 12 weeks. Apart from this, reinforcement will be given individually during their subsequent visits to the OPD every month (total 3 visits- 4 weeks, 8 weeks & 12 weeks).  
Comparator Agent  Standard treatment  Cardiologists consultation & prescription for medications and their advise 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with a clinical diagnosis of Heart Failure who are 18 years or above, with reduced ejection fraction (equal to or less than 40%), NYHA functional class II to III, having a smartphone or an android tablet and the knowledge to use these devices or a caregiver who has the knowledge to use these devices, able to read and speak Malayalam language and willing to participate. 
 
ExclusionCriteria 
Details  Patients with a clinical diagnosis of Heart Failure who have a documented history of:
-coexisting terminal illness (cancer, or primary organ failure- CLD, CKD, interstitial lung disease, stroke).
-psychiatric illness and dementia.
-receiving advanced heart failure therapies (VADs/ transplant)

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Self-care behaviour, Clinical outcomes- left ventricular ejection fraction, readmission, functional status, mortality; and Quality of Life  Self-care behaviour and NYHA functional class will be measured at baseline, 4 weeks, and 12 weeks. LVEF and QoL will be measured at baseline and 12 weeks. Readmission will be measured at 4 weeks and 12 weeks.  
 
Secondary Outcome  
Outcome  TimePoints 
Medication adherence  baseline, 4 weeks, 12 weeks 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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 3 
Date of First Enrollment (India)   15/10/2024 
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="2"
Months="1"
Days="1" 
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  
This study is a randomized controlled trial with a parallel arm to evaluate the effectiveness of the Self-care Intervention Program (SIP) on self-care behaviour, clinical outcomes and quality of life of patients with heart failure attending Medical College Hospital, Thiruvananthapuram, Kerala. Self-care Intervention Program (SIP) includes face -to-face instruction with teach-back method by using video-assisted teaching on various aspects of self-care in heart failure for patients and their caregivers, demonstration of checking body weight, symptom and event diary and a leaflet on self-care. reinforcement will be through an online platform (WhatsApp group) and during subsequent OPD visits. The control group will receive only standard care. The primary outcome measures are self-care behaviour, clinical outcomes (LVEF, readmission, NYHA functional class and mortality) and quality of life. The secondary outcome is medication adherence. Self-care behaviour, NYHA functional class and medication adherence will be measured at baseline, 4 weeks and 12 weeks. LVEF and QoL will be measured at baseline and 12 weeks. Readmission will be measured at 4 weeks and 12 weeks.



 
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