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CTRI Number  CTRI/2024/08/072687 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Nurse-led educational intervention on self-care behaviour, clinical outcomes and quality of life among heart failure patients 
Scientific Title of Study   Effect of Nurse-led mHealth and module-based educational intervention on self-care behaviour, clinical outcomes and quality of life among heart failure patients: Three-arm 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  Nipin Kalal 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No. Cn: 106, College Of Nursing AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  08955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar Bishnoi 
Designation  Assistant Professor 
Affiliation  Atal Bihari Vajpayee Medical University, UP, 
Address  Atal Bihari Vajpayee Medical University, UP, India
CG City, Sultanpur Road, Lucknow- 226002, India
Lucknow
UTTAR PRADESH
226002
India 
Phone  08003996929  
Fax    
Email  ashokbishnoi11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nipin Kalal 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No. Cn: 106, College Of Nursing AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  08955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS JODHPUR, Bansi Phase 2 Jodhpur, Rajastha, India, PIncode-342005 
Type of Sponsor  Government medical college 
 
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 
Nipin Kalal  AIIMS Jodhpur  Room no., 508 cardiology Unit
Jodhpur
RAJASTHAN 
8955945598

kalalnipin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee All India Institute of Medical Sciences Jodhpur e  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  m-Health and module-based educational intervention  Step 4: Intervention All study participants will receive usual care, which includes all medical, nursing, allied health, and follow-up services provided by the study hospital. In addition to usual care, experimental Group-A will receive mHealth intervention and an experimental Group-B module based educational intervention, respectively. The control group receives the usual care from the health workers in the hospital. The training manual will be available in English and Hindi, both versions will be written in simple sentences with descriptive images to aid patient’s understanding. Details of the nurse led education intervention are described below. Experimental Group-A: mHealth: Experimental group-A will be provided the mHealth educational intervention on following topics: -About disease condition, Fluid management, Diet, Weight management, Walking tips, Sexual activity, Medication, Physical exercises, Medication safety tips, Psychological well-being, Stress reduction, Symptomatic self-care, Warning signs, life style modification (Smoking, alcohol), Follow-up. Health component of artificial intelligence will be added which will help for medication and exercise reminder. This is also showing the red alert in case of abnormal data like vital signs, weight monitoring and fluid balance. Participants will be instructed to maintain a daily log of clinical data, fluid intake and medication. Patients will also be informed to call if they find any health issue and can clarify their doubts. Experimental Group-B: Module based-educational intervention: Experimental Group-B will receive the module-based educational intervention consist of health education and Education booklet will be provided to the intervention group patients at the time of discharge. On the day of visiting hospital (OPD) or discharge (IPD) a tailored discharge health education will be given. Same time the booklet will be handover to the participants which will include the following components: About disease condition, Fluid management, Diet, Weight management, Walking tips, Sexual activity, Medication, Physical exercises, Medication safety tips, Psychological well-being, Stress reduction, Symptomatic self-care, Warning signs, life style modification (Smoking, alcohol), Follow-up. Following the discharge, participants will receive the telephonic call once in a two week to reinforce the teaching. The patients will be advised to follow the instructions available in the education booklet. Participants will be instructed to maintain a daily log of clinical data, fluid intake and medication.  
Comparator Agent  Standard routine care  The control group will receive standard care, which includes all medical, nursing, allied health, and follow-up services offered by the study hospital. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient age 18 years or older
2. Patients or family members who uses android smartphone mobile
3. Patient who had been clinically diagnosed with heart failure
4. Patients who can understand Hindi or English language.
5. Patients who can come to the hospital for follow-up visits.
 
 
ExclusionCriteria 
Details  1. Critically ill patients and terminal illness (CKD, ESRD, MODS, COPD) that affect self-care ability and completion of the study.
2. Patients with Class IV Killip heart failure. 3. Patients with Hearing impairment or deafness.
4. Patient with dementia or other mental health disorder (impaired cognitive functioning).
5. No internet access at home.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Self-Care behaviour
Clinical outcomes
Quality of life
 
Baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Re-admission rate
Mortality rate
 
2 Years 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "153"
Final Enrollment numbers achieved (India)="51" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 20/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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  

Heart failure (HF) is a complex, multifactorial syndrome resulting from impaired heart function. The estimated prevalence of heart failure (HF) in India is approximately 1% of the Population or about 810 million people and the estimated mortality from heart failure is about 0.10 to 0.16 million people per year. A randomised controlled trial is proposed to examine the nurse led mHealth and module-based educational intervention on self-care behaviour, clinical outcomes and quality of life among heart failure patients. The expected results of the nurse led mHealth and module-based educational intervention would help the heart failure patients to be knowledgeable about their disease, acquire skills needed to monitor and recognize their symptoms and perform adequate self-care. All study participants will receive usual care, which includes all medical, nursing, allied health, and follow-up services provided by the study hospital. After obtaining the participants informed consent the researcher will collect the baseline data. It will include the sociodemographic variables, clinical profile, clinical outcomes, Self-Care of heart failure index (SCHFI), Cardiac self-efficacy scale (CSES), Health related quality of life (HRQoL-Minnesota living with heart failure questionnaire), Symptoms status question heart failure (SSQHF), Medication adherence rating scale. The researcher will contact the participants and arrange appointments to collect post intervention data at 3 months from baseline (T1), and 6 months from baseline (T2). The collected data will be analyzed using descriptive and inferential statistics with software like SPSS 20 and Microsoft Excel, and the results will be presented in the form of tables, graphs, and figures. Findings of the study will be disseminated. 

 
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