Trial no.:
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PACTR202307694422939 |
Date of Approval:
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12/07/2023 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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Therapeutic education of coronary patients: creation of a digital platform for monitoring |
Official scientific title |
Therapeutic education of coronary patients: creation of a digital platform for monitoring |
Brief summary describing the background
and objectives of the trial
|
Cardiovascular disease remains a leading cause of death worldwide including in Tunisia, with about 49% of the deaths from coronary heart disease (CHD). Faced with the increase in the number of chronic diseases with the aging of the population, and with the observation of the insufficiency of therapeutic control, a new need has emerged, that of having a patient as a partner in care. Therapeutic education is a humanistic approach centered on the patient, his needs, and resources. It is proposed not only to help the patient understand the disease and treatment but also to help them become autonomous.
However, in most therapeutic education programs, patient follow-up stops after the end of the education program. It is essential to assist the coronary patient in the third phase of his management. Thus, our study aims to create a digital platform allowing the follow-up of patients after having benefited from a therapeutic education program.
This is an innovative project in our Tunisian context that offers new modes of monitoring and therapeutic support to patients suffering from cardiovascular pathology. Indeed, it is the 1st digital platform for monitoring patients with coronary disease in Tunisia.
This study is a controlled clinical trial. It will be conducted from May 2022 to December 2023. A total of 100 patients with coronary heart disease will be recruited from one clinical site and equally assigned into two groups: the intervention group and a control group. Patients who are assigned to the intervention group will receive therapeutic education at first. The digital platform will then allow healthcare providers to accompany them outside the hospital walls. The primary outcome is the incidence of major cardiovascular events within 1 year of discharge. Main secondary outcomes include changes in health behaviors, medication adherence, and quality of life score. The control group will receive the usual controls at the hospital.
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Type of trial |
CCT |
Acronym (If the trial has an acronym then please provide) |
none |
Disease(s) or condition(s) being studied |
Circulatory System |
Sub-Disease(s) or condition(s) being studied |
|
Purpose of the trial |
Rehabilitation |
Anticipated trial start date |
01/05/2022 |
Actual trial start date |
01/05/2022 |
Anticipated date of last follow up |
31/12/2023 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
100 |
Actual target sample size (number of participants) |
|
Recruitment status |
Recruiting |
Publication URL |
none |
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