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Effect of an intervention to mitigate barriers in participation and adhesion to the programs of Cardiac Rehabilitation, a Clinical Trial Randomized.

Effect of an educational health intervention to mitigate barriers in participation and adhesion to the programs of Cardiac Rehabilitation, a Clinical Trial Randomized.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000846527
Enrollment
118
Registered
2024-07-08
Start date
2024-08-05
Completion date
2024-12-31
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective is to evaluate the effect of an intervention to mitigate barriers in participation and adherence to cardiac rehabilitation programs, created by the "International Council of Cardiovascular Prevention and Rehabilitation (ICCPR)", through a randomized clinical trial. The present research provides the opportunity to implement a useful and effective strategy to promote participation and adherence to cardiac rehabilitation programs in Colombia.

Interventions

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

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.

Sponsors

Juan Carlos Sánchez Delgado. University of Santander. UDES
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026