Increasing the quality of life and controlling the symptoms in patients with congestive heart failure
Design
Randomized, double-blind, parallel group controlled trial using balanced block randomization table on 40 patients with congestive heart failure
Settings and conduct
40 patients with congestive heart failure referring to cardiology clinic of Rasool-E-Akram hospital who meet the inclusion criteria will enter the study, and then will get divided into two case and control groups using balanced block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
diagnosis of congestive heart failure according to American Heart Association (AHA) guidelines
age between 50 to 75 years old
diagnosis of the disease at least one year prior to the study
having access to smartphone and knowledge of using mobile applications
Exclusion criteria:
diagnosis of heart failure with preserved ejection fraction
having underlying diseases such as HIV, cirrhosis, kidney transplant,...
not having access to a smartphone, or not being able to use one.
Intervention groups
Patients meeting the inclusion criteria will be divided into two case and control group and will be followed for 6 months. The HEART application will be installed on the smartphone of patients in the case group, will be instructed to use it daily on a regular basis. Patients of the control group will receive the pdf file and will be told to contact the physicians as needed.
Main outcome variables
Controlling the clinical symptoms; preventing disease progress, and preventing hospitalization due to decompensation of heart failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210427051097N1
Registration date:2022-06-15, 1401/03/25
Registration timing:retrospective
Last update:2022-06-15, 1401/03/25
Update count:0
Registration date
2022-06-15, 1401/03/25
Registrant information
Name
Arefeh Zavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 0530
Email address
zavari.hd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Study of the Effectiveness of the HEART Application Use on Clinical Outcomes and Quality of LIfe of Patients with Heart Failure
Public title
Evaluation of the using HEART Application in Patients with Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having Heart Failure According to AHA Criteria
Age between 50 to 75 years old
At Least 1 Year has Passed from Diagnosis
Having Access to a Smartphone and knowledge to Use it
Exclusion criteria:
Lack of Access to Smartphone
Having Heart Failure with Preserved Ejection Fraction
Having Rare Disease such s HIV, Liver Transplantation and ...
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After signing an informed consent, patients will be recruited in the study. This study will have two assigned groups (treatment or T, and control or C). A block with the size of 4 patients will be defined, and all possible balanced combinations of assignment within the blocks will be calculated. Then, patients will be assigned to one of the two groups, using a random number table, by a third person (rather than the physician and the researcher).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: Each target and control group participant will receive a file for the assigned intervention (application or the PDF booklet). If a patient needs companionship to receive the file, only one companion will be allowed in the room. To sum up, only the interventionist, the patient, and a maximum of one companion will be present in the room. Patients will be assigned visit times with a 30-minute interval to prevent crowding. With each patient being visited at separately assigned visit times, the goal of a minimum chance of patients seeing each other will be achieved.
Patients will receive the required explanations to avoid talking to the physician about the assigned intervention, and in case of speaking of it, only refer to it as the "intervention". After receiving the file (target or control), patients will leave the location.
Clinical caregiver: The physician will be blinded to the intervention type in all stages of the intervention including visiting and follow-up till the end of the study. The physician will be instructed to avoid speaking about the type of intervention to the patients, and in case of talking about it, refer to it as the ''intervention''.
Data analyst: After gathering all data, the data analyst will receive a version of the data with blinded intervention groups and with no personal information. Then, the data analyst reports the results.
Interventionist: The interventionist will be aware of the intervention groups and type of the intervention in both groups.
Application developer: Designing the application will be done before patient selection and randomization. The developer will be blinded to the intervention groups until the end of the study.
All people involved in the study will be banned from sharing information regarding the assigned groups until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
NO 52, first west 12 metri, second south 16 metri, west chaharbagh Blvd, south Jannat Abad
City
Tehran
Province
Tehran
Postal code
1474713361
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.IUMS.FMD.REC.1399.765
Health conditions studied
1
Description of health condition studied
congestive heart failure
ICD-10 code
I50.32
ICD-10 code description
Chronic diastolic (congestive) heart failure
Primary outcomes
1
Description
score of SF-36 (Short-Form-36) questionnaire
Timepoint
calculating the score of SF-36 questionnaire during a 6 month period
Method of measurement
using SF-36 questionnaire
2
Description
score of MLHFQ questionnaire (Minnesota Living with Heart Failure Questionnaire)
Timepoint
calculating the score of MLHFQ questionnaire during a 6 month period
Method of measurement
using MLHFQ questionnaire
3
Description
score of EHF.ScB-9 questionnaire (European Heart Failure Self-care Behavior Scale-9)
Timepoint
calculating the score of EHF.ScB-9 questionnaire during a 6 month period
Method of measurement
using EHF.ScB-9 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using HEART APPLICATION . We are trying to encourage patients with heart failure to better control their weight, blood pressure, and diet, improve their compliance to medication, and increase their physical activity level. We hypothesize that this intervention and these lifestyle modifications will prevent disease progression, hospitalization due to decompensated heart failure, and death. This application will be used daily. Every morning, each patient will enter the information regarding their symptoms including leg swelling, dyspnea, night-time sleep quality, etc., along with the other features of the application. After entering the information, the patients will see their performance based on the score they earn by answering the questions. The performance will display with different colors. If the displayed color is red, the patient must refer to the hospital for seeking medical care, or call the third person of the study for guidance. Also, a reminder will be set to remind the patients twice daily, once in the morning and once at night, to take their medications. The aim of the study is to help the patients adhere to the lifestyle modifications, and no new medication or substance is used in the study. We also do not interfere or change the medication regimen of the patients, and they will take their medications as prescribed by their doctor.
Category
Lifestyle
2
Description
Control group: transferring a pdf file containing healthy life style recommendations for congestive heart failure patients, to the smartphone of patients of the control group. To provide a similar file, the patients in the control group will receive an educational file containing 180 short sentences (lifestyle modification tips), and they will be suggested to read one sentence each day, and try to adapt to that. Same as the intervention group, the patients will not receive any medication or substance. Also, no change will be made in the medication regimen of the patients, and they will take their medications as prescribed by their doctor.
Iran University of Medical Science, Hemmat Exp, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Hassanzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasool-E-Akram Hospital, Niyayesh Ave, Sattarkhan Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0098 21 64351
Email
drmhxim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Hassanzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasool-E-Akram Hospital, Niyayesh Ave, Sattarkhan Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0098 21 64351
Email
drmhxim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Hassanzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasool-E-Akram Hospital, Niyayesh Ave, Sattarkhan Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0098 21 64351
Email
drmhxim@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data of this study will be available, publishable and reachable upon request, with respect to patients' privacy and without revealing their names or personal information.
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Employees of academic institutions and people working in industry
Under which criteria data/document could be used
Only those in charge will have access to the data.
What processes are involved for a request to access data/document
Introduce yourself and your job position
Authentication
Submission of a letter from the legal authorities to the responsible person
Review the application for a maximum of 6 months
Sending requests after a written commitment not to misuse information scientifically and financially