Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001446752
Ethics application status
Approved
Date submitted
21/10/2021
Date registered
14/11/2022
Date last updated
14/11/2022
Date data sharing statement initially provided
14/11/2022
Date results information initially provided
14/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an Educational Intervention In Cardiac Rehabilitation Through Whatsapp Using A Randomized Controlled Clinical Trial
Scientific title
Evaluation of the effect of an educational intervention delivered via WhatsApp on cardiovascular knowledge, physical activity levels, and mental health in adults attending cardiac rehabilitation
Secondary ID [1] 305481 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 323861 0
Cardiac Rehabilitation 323862 0
Condition category
Condition code
Cardiovascular 321378 321378 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 321379 321379 0 0
Other physical medicine / rehabilitation
Public Health 321380 321380 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The WhatsApp intervention group (16 participants) and the control group (16 participants) will receive the usual care provided by the "Profesionales de la Salud" Rehabilitation center (supervised exercise sessions and short educational lectures).

Supervised exercise sessions (Provide to both the intervention group and control group):
Participants will receive five 45-minute sessions of exercise per week for 4 to 6 weeks. The number of weeks depends on the number of sessions prescribed by the cardiologist. Each session will include 5 minutes of warm-up, 30 minutes of moderate-intensity exercise on the treadmill or recumbent bike, 10 minutes of endurance exercise, and finally, a cooldown phase of 5 minutes. The sessions will be conducted in an outpatient clinic located in a tertiary care center called "Complejo Médico FOSCAL." The exercise sessions will be delivered concurrently with respect to the WhatsApp educational intervention.

Short educational lectures (Provide to both the intervention group and control group):
Participants will receive a 10-minute lecture two times per week over 4 to 6 weeks, depending on the number of sessions prescribed by the cardiologist. The educational lectures will be delivered concurrently with respect to the WhatsApp educational intervention over the same 4-week period and will be provided in groups of no more than 10 participants.

WhatsApp Intervention (provide only to the intervention group):
In addition, the intervention group will receive the educational intervention by daily WhatsApp messages including videos, images and/or podcasts, explicitly designed for this study. The number of participants in each WhatsApp group will be to a maximum of 4 participants per group. The WhatsApp Intervention will be delivered concurrently over the same 4-week period for those with a 4-week exercise intervention and in the first 4-weeks for those with a 6-week exercise intervention.

There will be a theme by week as follows: arterial hypertension, diabetes, smoking and dyslipidemia. The WhatsApp messages will be sent for four weeks from Monday to Friday, at 8:00 AM. Participants will receive an image of the physiopathology related to the weekly theme on Monday, an image with relevant information of the weekly theme on Tuesday, an image and a podcast about nutritional recommendations on Wednesday, a video of physical activity on Thursday, and an image with motivational phrases on Friday. In addition, every day after sending the message, the researchers will solve questions related to the information received by the participants.

Adherence to the intervention
Adherence to the supervised exercise sessions and short educational lectures will be monitored by an attendance signature. In addition, the providers of the intervention will check the WhatsApp read receipts through the WhatsApp option "read by" at 8 PM every day from Monday to Friday.

Providers
The physiotherapists and kinesiologists of the "Profesionales de la Salud" Rehabilitation center will deliver the usual care. However, this usual care will not be provided by the research group.
Two physiotherapists will deliver the WhatsApp intervention. One of them is specialized in cardiac rehabilitation, completed a Master in education, and is a physiotherapy professor with 12 years of clinical experience in cardiac rehabilitation. The second physiotherapist is specialized in neurorehabilitation, completed a Master of Science in physiotherapy, and is a physiotherapy professor with 14 years of clinical experience in cardiac rehabilitation.
Intervention code [1] 321908 0
Rehabilitation
Intervention code [2] 322456 0
Behaviour
Comparator / control treatment
Control group: usual care.
Usual care includes the same supervised exercise sessions and short educational lectures delivered to the WhatsApp intervention group.
Control group
Active

Outcomes
Primary outcome [1] 329186 0
Cardiovascular risk factor knowledge score
Test name: Knowledge questionnaire
It was designed and validated specifically for this study.
Timepoint [1] 329186 0
Primary timepoint: 4 weeks immediately post-intervention commencement
Second timepoint: 3 months post-intervention completion
Third timepoint: 6 months post-intervention completion
Endpoint: 12 months post-intervention completion
Secondary outcome [1] 401729 0
Physical activity levels. It will be assessed by the International Physical Activity Questionnaire (IPAQ)
Timepoint [1] 401729 0
First timepoint: 4 weeks immediately post-intervention commencement
Second timepoint: 3 months post-intervention completion
Third timepoint: 6 months post-intervention completion
Endpoint: 12 months post-intervention completion
Secondary outcome [2] 409028 0
Anxiety and depression score. It will be assessed by Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 409028 0
First timepoint: 4 weeks immediately post-intervention commencement
Second timepoint: 3 months post-intervention completion
Third timepoint: 6 months post-intervention completion
Endpoint: 12 months post-intervention completion

Eligibility
Key inclusion criteria
• Age > 18 years old
• Have a smartphone with a data plan or access to Wi-Fi network
• Have and know how to use the WhatsApp application
• Demonstrate basic mastery in the use of the WhatsApp application (review audiovisual content and answer a question about the resources).
• Have a prescription of at least 20 cardiac rehabilitation sessions
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have previously carried out a cardiac rehabilitation (CR) program
• Have a previous diagnosis of depression and anxiety
* Cognitive impairment (Mini-Mental Test <25)
* Institutionalized patients
* Patients with severe co-morbidities for whom CR is contra-indicated
* Patients who sustained a severe surgical complication preventing them from participating in CR (general stroke with severe disability)

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 involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated, based in Tang's et al (2018) outcomes, applying 80% power, 5% significance level, and 1:1 ratio, using the test for comparison of means, and standard deviation, and doubling this amount for possible loss to follow-up.

STATISTICAL ANALYSIS:
univariate analysis: descriptive statistics will be carried out, through means and standard deviations for the quantitative variables and frequency tables for the categorical variables.

The bivariate analysis will be carried out to evaluate the differences within and between groups through Chi2 test.

To assess changes through follow-up, a repeated measures ANOVA will be use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/04/2022
Date of last participant enrolment
Anticipated
Actual
15/07/2022
Date of last data collection
Anticipated
Actual
15/08/2022
Sample size
Target
32
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 24195 0
Colombia
State/province [1] 24195 0
Santander

Funding & Sponsors
Funding source category [1] 309838 0
University
Name [1] 309838 0
University of Santander
Country [1] 309838 0
Colombia
Funding source category [2] 309896 0
Other
Name [2] 309896 0
Profesionales de la Salud
Country [2] 309896 0
Colombia
Funding source category [3] 309897 0
University
Name [3] 309897 0
University Manitoba
Country [3] 309897 0
Canada
Primary sponsor type
University
Name
Universidad de Santander,
Address
Calle 70 N° 55-210, Bucaramanga, Santander, 680003
Country
Colombia
Secondary sponsor category [1] 310873 0
Other
Name [1] 310873 0
Profesionales de la salud
Address [1] 310873 0
,Cl. 46 #33-16, Bucaramanga, Colombia, Postal Code: 680003
Country [1] 310873 0
Colombia
Secondary sponsor category [2] 310925 0
Individual
Name [2] 310925 0
Diana Carolina Sanchez Ramirez
Address [2] 310925 0
66 Chancellors Cir, Winnipeg, MB R3T 2N2, Canadá
Country [2] 310925 0
Canada
Other collaborator category [1] 282019 0
Individual
Name [1] 282019 0
Zully Rocio Rinco
Address [1] 282019 0
Universidad of Santander, Calle 70 N° 55-210, Bucaramanga, Santander Postal Code: 680003
Country [1] 282019 0
Colombia
Other collaborator category [2] 282090 0
Individual
Name [2] 282090 0
Adriana Angarita Fonseca
Address [2] 282090 0
Universidad of Santander, Calle 70 N° 55-210, Bucaramanga, Santander Postal Code: 680003
Country [2] 282090 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309579 0
Ethics Committee Universidad de santander
Ethics committee address [1] 309579 0
Calle 70 N° 55-210, Bucaramanga, Santander Colombia 680003
Ethics committee country [1] 309579 0
Colombia
Date submitted for ethics approval [1] 309579 0
Approval date [1] 309579 0
08/06/2021
Ethics approval number [1] 309579 0
Acta 023 08 de junio 2021

Summary
Brief summary
This study aims to assess the effect of an educational intervention delivered by WhatsApp among participants enrolled in a cardiac rehabilitation program. Both control and intervention groups will receive supervised exercise and short educational lectures. In addition, the intervention group will receive a 4-week educational intervention via WhatsApp. We will assess cardiovascular risk factor knowledge score, physical activity levels, anxiety and depression, and quality of life through self-administered questionnaires at baseline, 4-weeks, 3-month, 6-month and 12-month post-enrollment. Differences between control and intervention groups and pre-and post-intervention periods will be evaluated. We hypothesize that people who receive the structured educational intervention using WhatsApp will show better results in the immediately post-intervention assessment, and these benefits will remain up to 12 months later compared with people who will receive usual care in a cardiac rehabilitation program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114654 0
Prof Adriana Marcela Jacome Hortua
Address 114654 0
Universidad de Santander, Calle 70 N° 55-210, Bucaramanga, Santander 68003
Country 114654 0
Colombia
Phone 114654 0
+573107899030
Fax 114654 0
Email 114654 0
ad.jacome@mail.udes.edu.co
Contact person for public queries
Name 114655 0
Miss Zully Rocio Rincon Rueda
Address 114655 0
Universidad de Santander, Calle 70 N° 55-210, Bucaramanga, Santander
Country 114655 0
Colombia
Phone 114655 0
+573102289525
Fax 114655 0
Email 114655 0
zu.rincon@mail.udes.edu.co
Contact person for scientific queries
Name 114656 0
Miss Zully Rocio Rincon Rueda
Address 114656 0
Universidad de Santander, Calle 70 N° 55-210, Bucaramanga, Santander
Country 114656 0
Colombia
Phone 114656 0
+573102289525
Fax 114656 0
Email 114656 0
zu.rincon@mail.udes.edu.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The de-identified, raw, line-by-line individual participant data will not be available for this study.
The data collected in the study will be treated and protected in accordance with Law 1581 of 2012, guaranteeing the owner of the information the rights established by Colombian legislation. It is important to specify that, through informed consent, each participant will be asked for authorization to process the information obtained, which will be used for academic purposes and encrypted to guarantee their anonymity. This information will be stored for five years at the University of Santander (UDES) under the responsibility of the Principal Investigator.


What supporting documents are/will be available?




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.