Determining the effectiveness of e-health education based on the therapeutic engagement model on the health and behavioral outcomes of patients with heart failure
Design
A parallel-group, single-blind, blocked randomization controlled clinical trial on 88 patients
Settings and conduct
This study will be conducted as a randomized clinical trial on 88 heart failure patients over the age of 18 who have completed the informed consent form in Farshchian Cardiovascular Hospital affiliated to Hamedan University of Medical Sciences in Hamedan city. In addition to routine treatment, intervention group patients will also receive e-health education. The study is one-way blind, the data analyst will not know about the division of patients into test and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients who have been diagnosed with heart failure class I to III by a cardiologist; are over 18 years old; literate; willing to participate in the study; have the access to the internet by patient or a family member who lives with; have been diagnosed with heart failure for at least 6 months; and have no psychiatric diseases; and the exclusion criteria include severe emergency conditions; patient’s refusal to continue the study; patient’s death; and participation in other educational programs.
Intervention groups
Intervention group: despite receiving routine training, patients will receive remote training through the website for three months using a special password; By entering the website, they benefit from its educational content and are followed up by making phone calls and sending and receiving messages. Control group: Patients will receive routine discharge training according to the current hospital program and no additional training.
Main outcome variables
Self-care; health related quality of life; medication adherence; physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240304061168N1
Registration date:2024-05-21, 1403/03/01
Registration timing:registered_while_recruiting
Last update:2024-05-21, 1403/03/01
Update count:0
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Mohammad Reza Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 1772
Email address
mohammad.r.gh.138222@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of e-health education based on the therapeutic engagement model on the health and behavioral outcomes of patients with heart failure
Public title
The effect of e-health education on patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of heart failure class I to III confirmed by a cardiologist
Reading and writing literacy
Over 18 years of age
Desire to participate in the study
Internet access by patient or a family member who lives with patient
Absence of psychiatric diseases
Having heart failure for at least 6 months
Exclusion criteria:
Having severe emergency conditions
Patient refusal to continue the study
Patient’s death
Participation in other educational programs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
First, among the patients who meet the inclusion criteria, they will be selected using the available sampling method and based on the random block method, they will be assigned to either the e-health education group based on the therapeutic engagement model (intervention) or the group receiving routine training (control). For this purpose, the researcher will prepare 4 sheets, with the number "1" written on two sheets for the first group and the number "2" written on two sheets for the second group. The cards will be mixed in a container and randomly drawn one at a time for each patient without replacement until all four cards are drawn. Then four sheets will be returned to the container, and this process will be repeated until the calculated sample volume is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analysis and outcome assessment will not know about the assignment of patients to two intervention and control groups during the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838698
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.UMSHA.REC.1403.087
Health conditions studied
1
Description of health condition studied
Patients with heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Self-care
Timepoint
Before and 3 months after the end of the intervention
Method of measurement
Using the self-care of heart failure index by Riegel et alia: The self-care of heart failure index was designed and compiled by Riegel et alia in 2004 to measure the self-care in heart failure patients. This questionnaire consists of 3 scales with 22 questions, including 10 questions for self-care maintenance, 6 questions for self-care management, and 6 questions for self-care confidence. Each scale is standardized with a possible score from 0 to 100.
Secondary outcomes
1
Description
Medication adherence
Timepoint
Before and 3 months after the end of the intervention
Method of measurement
Using the medication adherence reporting scale by Yan Chen et alia: The medication adherence reporting scale was compiled by Yan Chen et alia in 2019. This questionnaire contains of 5 questions, and the frequency rating of each behavior in this questionnaire is based on a 5-point scale that is graded from never to always. The total score of the scale ranges from 5, which indicates the lowest level of adherence, to 25, which indicates the highest level of adherence.
2
Description
Physical activity
Timepoint
Before and 3 months after the end of the intervention
Method of measurement
Using the rapid assessment of physical activity questionnaire by Topolski et alia: The rapid assessment of physical activity questionnaire was compiled by Topolski et alia in 2006 in order to measure the physical activity. This questionnaire contains of 9 questions designed to evaluate strength, flexibility and level and intensity of physical activity. The total score of the first seven items is from 1 to 7 points, with the respondent's score categorized into one of five levels of physical activity: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active. Responses to the strength training and flexibility items are scored separately, with strength training = 1, flexibility = 2, or both = 3.
3
Description
Health related quality of life
Timepoint
Before and 3 months after the end of the intervention
Method of measurement
Using the MacNew Heart Disease health-related quality of life questionnaire by Valenti et alia: The MacNew Heart Disease health-related quality of life questionnaire was designed and compiled by Valenti et alia in 1996. This questionnaire consists of 27 items which fall into three domains [a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale]. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The maximum possible score in any domain is 7 [high HRQL] and the minimum is 1 [poor HRQL].
Intervention groups
1
Description
Intervention group: After introducing the study and stating its objectives, if desired, the patients will complete the informed consent form, the demographic information form, self-care of heart failure index, medication adherence reporting scale, rapid assessment of physical activity, and MacNew questionnaires. In addition to receiving routine training during discharge that is provided in the hospital, patients will benefit from an educational website about heart failure developed by the research team. Participants in the intervention group are given usernames and passwords specific to each of them, and basic training is provided on how to use each of the website's components. The website will be provided to the intervention group for three months and they will benefit from its educational content by using the website. Different sections of the website include educational modules related to understanding heart failure, the causes and complications of this disease, services that can be provided by the relevant doctor or nurse, self-efficacy and self-management training for the patient, lifestyle modification, the section related to caregivers, warning signs and questions that can be exchanged with the doctor, simple language animations for better visual understanding by patients of the condition, interviews with various patients going through different stages of treatment, practical tools for increasing self-efficacy and adherence to treatment including symptoms and events diary, monitoring chart, appointment record, warning signs, and medicine chart as well as a section for patient question and answer. To follow up and motivate the patients in the intervention group, phone calls will be made to them once a week in the first month and once every two weeks in the next two months. Also, patients can ask the researcher through the website whenever they have a question. The study outcomes will be assessed through questionnaires at pre-study and 3 months after the end of the intervention.
Category
Treatment - Other
2
Description
Control group: In this group, patients will enter the study after receiving informed consent and will complete the questionnaires. These people will only undergo routine training during hospital discharge and will not receive e-health education. At the end of the study, the educational content of the website will be provided to this group in the form of a booklet. The study outcomes will be assessed through questionnaires at pre-study and 3 months after the end of the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Cardiovascular Hospital
Full name of responsible person
Mohammad Reza Ghorbani
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
mohammad.r.gh.11382@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghorbani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
mohammad.r.gh.11382@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Pakrad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
f_pakrad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghorbani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
mohammad.r.gh.11382@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I must provide all information for the sponsoring institution