Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000846527
Ethics application status
Approved
Date submitted
13/03/2024
Date registered
8/07/2024
Date last updated
8/07/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an intervention to mitigate barriers in participation and adhesion to the programs of Cardiac Rehabilitation, a Clinical Trial Randomized.
Scientific title
Effect of an educational health intervention to mitigate barriers in participation and adhesion to the programs of Cardiac Rehabilitation, a Clinical Trial Randomized.
Secondary ID [1] 311724 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 333209 0
lung disease 333513 0
Condition category
Condition code
Cardiovascular 329895 329895 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 330194 330194 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized controlled clinical trial, with 2 parallel arms, 1:1 random assignment and blinding for outcome assessment. Initially, the Cardiac Rehabilitation Barriers Scale is completed.

Experimental group: will receive barrier mitigation strategies. Items that are rated as “agree” or “strongly agree” will be considered barriers, and a mitigation strategy will be derived for each of the identified barriers. Possible strategies are for example: cost (for example, costs for transportation, housing and food). the mitigation strategy is Ask the program about the option of a short rehabilitation plan. Check with your rehabilitation program if the institution has a social program that can provide support through housing, food or transportation services, find out if there are nearby low-cost accommodations.
Check with your program about the option to prioritize your assignment if you live out of town. If you definitely cannot afford to have your therapy at a cardiac rehabilitation center, we suggest that you get an appointment with a physical therapist to develop an exercise plan and then you could follow it.

A follow-up will be carried out at the end of the scheduled time of the sessions prescribed for each patient to determine the level of adherence in participation in the rehabilitation program.

At the end of the time scheduled for compliance with the sessions scheduled by your treating physician, a final interview will be conducted to learn about the perception of the mitigation strategy through semi-structured interviews.

Definition of mitigation strategy: actions aimed at improving patient participation and assistance in cardiac and pulmonary rehabilitation programs, within the framework of health education.

An example of a strategy is: the patient perceives distance as a barrier (for example, he is not located in the neighborhood where he lives, it is too far away for him to travel). The proposed strategy is to consult the cardiac rehabilitation program, if there is a program near your home or in your apartment. Also, ask if they have any plans for activities to do at home, or if they know of a place near the program where they can stay for a short period of time. If these options are not viable, ask if they have a short rehabilitation plan, that is, more times a week for less time. Finally, find out if there is an option for cardiac rehabilitation at home or via telerehabilitation. If there are no options for you to have your therapy at a cardiac rehabilitation center, we suggest that you make an appointment with a physical therapist to develop an exercise plan.

Once each participant meets the eligibility criteria, they must answer the EBRC Cardiac Rehabilitation Barriers Scale. According to the number of perceived barriers, the respective mitigation strategies will be assigned, therefore, the mitigation strategies will be individualized for each patient.

The strategy is sent once the patient answers the barriers scale. According to their responses to the perceived barriers, the designed strategy that corresponds to each barrier is sent.

the frequency for the derivation of the strategy is only once before starting participation in a cardiac rehabilitation program. Before starting their rehabilitation sessions, the patient who meets the eligibility criteria is contacted and the barrier scale is applied; according to their responses, the corresponding strategies are derived. A telephone follow-up is carried out after 2 weeks.
The strategy is derived online to the participant's email. If they do not have one, also PDF / screen shot the responses to share with the patient another way (print, Send via whatsapp)

The research team completes the answers to the barrier scale for the intervention group on the Qualtrics platform and the platform immediately derives the respective strategies.

In the institutions that provide cardiac rehabilitation services where patients attend, they monitor attendance at rehabilitation sessions, which will allow adherence to be monitored. Regarding the educational strategy to mitigate barriers, a follow-up will be carried out with a phone call 2 weeks after the start, as well as at the end of participation.
Intervention code [1] 328188 0
Rehabilitation
Comparator / control treatment
Control group: Will not receive barrier mitigation strategy. You will receive conventional treatment offered by the program.

The control group corresponds to subjects who meet the eligibility criteria and are going to attend a cardiac rehabilitation program at the institution that provides their health services but who will not receive the educational strategy to mitigate barriers to participation. Patients will attend their rehabilitation sessions according to the schedule given directly by their service provider, which is a daily session. In the institutions that provide cardiac rehabilitation services where patients attend, they monitor attendance at rehabilitation sessions, which will allow for adherence control.
Control group
Active

Outcomes
Primary outcome [1] 337662 0
Adherence in participation in the cardiac rehabilitation program
Timepoint [1] 337662 0
At the end of the sessions scheduled by your treating doctor. A telephone follow-up is carried out after 2 weeks.
Secondary outcome [1] 432741 0
Nil
Timepoint [1] 432741 0
Nil

Eligibility
Key inclusion criteria
Subjects with Spanish mother tongue who are referred to services phase II cardiac rehabilitation located in Cúcuta, Valledupar, Bucaramanga and its metropolitan area.

Yes, subjects must have previous cardiovascular disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who have already started cardiac rehabilitation treatment phase II. Patients with cognitive disorders that prevent them understand the questions and educational program included in this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It will be done by simple randomassignment. The generation of the sequence will be carried out by an epidemiologist who will not participate in the interventions, evaluation of the outcome or statistical analysis, and whom the principal investigator will contact by telephone. It will be carried out by simple random assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. Sealed envelope method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A non-probabilistic sampling will be performed for convenience.
For the statistical analysis, the Stata 14.0 software. The distribution analysis of the continuous variables is will be carried out through the Shapiro Wilk test, these will be presented in measurements of central tendency and dispersion, and for measurements on a nominal scale Absolute and relative frequencies will be calculated. The difference between Measurements will be compared between groups using Student's t test or Rank sum for independent data. The mean and deviation will be calculated utility rating standard. The proportions will be compared with Chi-2, accompanied by Fisher's exact test. It will be considered a level 5% alpha for the entire analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment outside Australia
Country [1] 26198 0
Colombia
State/province [1] 26198 0
Bucaramanga, Cúcuta, Valledupar

Funding & Sponsors
Funding source category [1] 316054 0
University
Name [1] 316054 0
Universidad de Santander
Country [1] 316054 0
Colombia
Primary sponsor type
University
Name
Juan Carlos Sánchez Delgado. University of Santander. UDES
Address
Country
Colombia
Secondary sponsor category [1] 318216 0
Individual
Name [1] 318216 0
Diana Marcela Niño. University of Santander. UDES
Address [1] 318216 0
Country [1] 318216 0
Colombia
Secondary sponsor category [2] 318217 0
Individual
Name [2] 318217 0
Jhon Alexander Rojas Caballero. University of Santander. UDES
Address [2] 318217 0
Country [2] 318217 0
Colombia
Secondary sponsor category [3] 318218 0
Individual
Name [3] 318218 0
Laura Marcela Uribe. University of Santander. UDES
Address [3] 318218 0
Country [3] 318218 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314874 0
Ethics Committee of Universidad de Santander-UDES
Ethics committee address [1] 314874 0
Ethics committee country [1] 314874 0
Colombia
Date submitted for ethics approval [1] 314874 0
31/05/2023
Approval date [1] 314874 0
01/06/2023
Ethics approval number [1] 314874 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133014 0
Prof Juan Carlos Sánchez Delgado
Address 133014 0
calle 70 No 55-210 Bucaramanga, Santander. University of Santander. UDES
Country 133014 0
Colombia
Phone 133014 0
+57 3157207661
Fax 133014 0
Email 133014 0
[email protected]
Contact person for public queries
Name 133015 0
Juan Carlos Sánchez Delgado
Address 133015 0
calle 70 No 55-210 Bucaramanga, Santander. University of Santander. UDES
Country 133015 0
Colombia
Phone 133015 0
+57 3157207661
Fax 133015 0
Email 133015 0
[email protected]
Contact person for scientific queries
Name 133016 0
Diana Marcela Niño Pinzón
Address 133016 0
calle 70 No 55-210 Bucaramanga, Santander. University of Santander. UDES
Country 133016 0
Colombia
Phone 133016 0
+57 3183901241
Fax 133016 0
Email 133016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have no intention to share this data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21851Study protocol  [email protected]
21852Statistical analysis plan  [email protected]
21853Informed consent form  [email protected]



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.