Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000210572p
Ethics application status
Not yet submitted
Date submitted
1/08/2023
Date registered
1/03/2024
Date last updated
1/03/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile Health Intervention among Heart Failure Patients
Scientific title
Mobile Health Intervention Impact on Self-Care Ability and Quality of Life among Heart Failure Patients
Secondary ID [1] 310270 0
Nil known
Universal Trial Number (UTN)
U1111-1296-0125
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure. 332631 0
Condition category
Condition code
Cardiovascular 327764 327764 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study will utilize the Mobile Application as an intervention tool to manage the self-care ability among heart failure patients. This application consists of six features such as; a) Medicines checklist, b) General & HF symptoms with Risk stratification, c) Vital Signs monitoring, d) Exercises, e) Performance tracker and connect with others, and e) HF Education. The mobile app will be developed with an additional feature of a beep alarm to remind the patients to follow these features.
1. Initially the participants will have access to the application for 12 months and definitely will be able to access information whenever they require.
2. We are planning to monitor the fidelity of the intervention by monitoring the primary investigator's phone. Whatever the patient adds to the above-shared features will be monitored on the primary investigator's phone as well as the clinical supervisor's phone.
Intervention code [1] 326648 0
Treatment: Devices
Comparator / control treatment
The control arm of the study will receive standard care in addition to the Educational pamphlets or brochures, including all features of the mobile application.
The control arm will receive the same features as like mobile application but in hard copy in the form of a booklet.
Standard care means which is already in practice in the study setting. The pamphlets and brochures are readily available (heart.org/HF© Copyright 2022 American Heart Association, Inc., a 501(c)(3) not-for-profit. All rights reserved. Unauthorized use is prohibited. DS18804 8/22). The primary investigator will get permission before the commencement of the study.
Pamphlets and brochures contain information regarding the following features.
- Medicine Chart for HF Management
- Self-Check Plan for HF Management
- How Can I Live With Heart Failure?
- What is Heart Failure?
This information has been developed by the American Heart Association (AHA). PI will get permission to utilize the current study before its commencement.
- Standard care for heart failure patients in a hospital setting involves a multidisciplinary approach to manage symptoms, improve quality of life, and prevent hospital readmissions. The following points will be monitored during standard care;
Diagnostic tests (echocardiogram, blood tests).
Assessment of symptoms, history taking, and physical examination.
Administer prescribed medication for heart failure i.e. (beta-blockers, ACE inhibitors, diuretics), etc.
Monitoring for medication side effects and adjusting doses as needed.
Monitoring daily weights.
Adjusting diuretic medications based on fluid status.
Addressing dyspnea, fatigue, and other symptoms through medications and lifestyle modifications. Educating patients on symptom recognition and when to seek medical attention.
Regularly reviewing and reconciling medications.
Control group
Active

Outcomes
Primary outcome [1] 335561 0
Self-Care Ability (measured by SCHFI R7.2-revised-2018).
Timepoint [1] 335561 0
Baseline, and 6 weeks after intervention commencement.
Primary outcome [2] 337546 0
Quality of Life by WHO QOL SHF.
Timepoint [2] 337546 0
Baseline, and 6 weeks after intervention commencement.
Secondary outcome [1] 424961 0
Identify the levels of depression among HF patients.
Cardiac Depression Scale (>100 indicates severe depression)
Timepoint [1] 424961 0
Baseline, and 6 weeks after intervention commencement

Eligibility
Key inclusion criteria
HF patients of both genders with recent hospitalizations
New York Heart Association (NYHA) classification III of HF
Having age of 40 years
Visiting outpatient departments at public and private hospitals, already diagnosed with HF 1 year and EF 40% and positive for cardiac depression (80%).
Ability to speak, understand, and read Urdu or English
Must be willing to use the mobile app.
Willing to participate in the study and giving consent to participate in the trial.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Listed for heart transplant as status
History of stroke within the past year
Major disability, such as aphasia
Individuals with cognitive impairment or other mental health issues
Living in a setting where they are not able to independently engage in self-care (e.g., skilled nursing facility)
Being involved in any other intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be followed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be followed by Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Two different study participants/groups will receive intervention according to the following plan;

Interventional Arm will receive intervention through mobile application whereas;
Control arm will receive intervention through educational pamphlets or brochure

Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive Statistics
Mean ± Standard Deviation:
Frequency & Percentages

Inferential Statistics
Linear Regression (group mean differences)
T-test (compare mean difference b/w Int.& c)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
24/11/2025
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment outside Australia
Country [1] 25683 0
Pakistan
State/province [1] 25683 0
Sindh

Funding & Sponsors
Funding source category [1] 314477 0
University
Name [1] 314477 0
Ziauddin University
Country [1] 314477 0
Pakistan
Primary sponsor type
University
Name
Ziauddin University
Address
4/B Shahrah-e-Ghalib Rd, Block 6 Clifton, Karachi, Karachi City, Sindh 75000Faculty of Nursing and Midwifery; Block-B, North Nazimabad, Karachi
Country
Pakistan
Secondary sponsor category [1] 317721 0
None
Name [1] 317721 0
Address [1] 317721 0
Country [1] 317721 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313528 0
Ethical Review Committee, Ziauddin University, Karachi-Pakistan.
Ethics committee address [1] 313528 0
4/B Shahrah-e-Ghalib Rd, Block 6 Clifton, Karachi, Karachi City, Sindh 75000
Ethics committee country [1] 313528 0
Pakistan
Date submitted for ethics approval [1] 313528 0
03/02/2025
Approval date [1] 313528 0
Ethics approval number [1] 313528 0

Summary
Brief summary
"Heart Failure (HF) is a chronic progressive disease affecting over 64 million individuals globally (Perez-Gutierrez et al., 2022, Savarese et al., 2022) and experts predict that the figure will keep rising over the following few decades due to society aging and other risk factors (Bragazzi et al., 2021, Topol and Califf, 2007).
Additionally, a mobile health intervention is also one of the management approaches for HF patients, along with medical therapy. To successfully manage HF, self-care is essential to preventing recurrent hospitalizations and enhancing quality of life (Toback and Clark, 2017, Vellone et al., 2017).
The interventional group received six features of the mobile app such as; a) Medicines checklist, b) General & HF symptoms with Risk stratification, c) Vital Signs monitoring, d) Exercises, e) Performance tracker & Connect with others, and e) HF Education."

"Mobile health intervention will help increase the self care ability and quality of life for patients with heart failure".
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128458 0
Mr Shahzad Bashir
Address 128458 0
Ziauddin University, Faculty of Nursing and Midwifery. Block-B, North Nazimabad, Karachi, Pakistan.
Country 128458 0
Pakistan
Phone 128458 0
+923461594640
Fax 128458 0
Email 128458 0
shahzad.bashi@zu.edu.pk
Contact person for public queries
Name 128459 0
Mr Shahzad Bashir
Address 128459 0
Ziauddin University, Faculty of Nursing and Midwifery. Block-B, North Nazimabad, Karachi, Pakistan.
Country 128459 0
Pakistan
Phone 128459 0
+9233362197835
Fax 128459 0
Email 128459 0
shahzad_shams125@yahoo.com
Contact person for scientific queries
Name 128460 0
Mr Shahzad Bashir
Address 128460 0
Ziauddin University, Faculty of Nursing and Midwifery. Block-B, North Nazimabad, Karachi, Pakistan.
Country 128460 0
Pakistan
Phone 128460 0
+923461594640
Fax 128460 0
Email 128460 0
shahzad.bashi@zu.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It's more complex therefore it will not included.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19864Informed consent form  shahzad_shams125@yahoo.com 386350-(Uploaded-28-11-2023-20-26-54)-Study-related document.docx
19865Statistical analysis plan  shahzad_shams125@yahoo.com 386350-(Uploaded-28-11-2023-20-27-11)-Study-related document.docx
19867Study protocol  shahzad_shams125@yahoo.com 386350-(Uploaded-27-02-2024-02-29-37)-Study-related document.docx
21077Other    Flow diagram of the data collection and proposed i... [More Details] 386350-(Uploaded-28-11-2023-20-27-52)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.