| 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
|
|
|
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
|
|
|
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
|
|
|
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. |