Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307694422939 Date of Approval: 12/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title 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.
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
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL none
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Therapeutic education and digital monitoring 20 months 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 digital platform is a multi-professional telemonitoring platform that allows care teams to accompany the patient outside the hospital walls. It allows the collection and transmit information from the patient's home to the therapeutic education team. All data will be secured at a certified host. The patient application provides data on compliance, adherence to physical activity (number of steps taken per day), adequate diet (weight gain, food consumed during the meal, compliance with low-salt or salt-free diet, diabetic diet), smoking cessation, as well as therapeutic compliance. Access to educational tools (digital media) is provided to all initial program participants. These tools will be updated annually by the rehabilitation team by the recommendations. The platform also offers the possibility of organizing an individual or group remote educational session (videoconference modules allowing group and individual sessions), a secure integrated caregiver-patient messaging system. 50
Control Group Usual controls at the hospital 20 months The control group will receive the usual controls at the hospital. Patients of the control group will not receive a therapeutic education program or a digital monitoring. 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patient with recent acute coronary syndrome with or without ST-segment elevation on electrocardiography. - Revascularized patient (angioplasty or coronary bypass surgery) - Patient who does not accept to participate 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/09/2022 Ethics committee of sahloul university hospital
Ethics Committee Address
Street address City Postal code Country
Sahloul Sousse 4054 Tunisia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2022 Ethics Committee of Sahloul University Hospital
Ethics Committee Address
Street address City Postal code Country
Rue de ceinture Sahloul Sousse 4054 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of major cardiovascular events within 1 year of discharge
Secondary Outcome changes in health behaviors, medication adherence, and quality of life score. at 3 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Cardiology Sahloul University hospital Sahloul street Sousse 4054 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Sahloul Sousse Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Myself Sahloul Sousse 4054 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hela Ghali hela.ghali@outlook.com +21624301810 Sahloul
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia Medical doctor
Role Name Email Phone Street address
Public Enquiries Aymen Hraeich elhraiech.aymen@yahoo.com +21699744608 Sahloul
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia Medical doctor
Role Name Email Phone Street address
Scientific Enquiries Chekib Zedini chekib.zedini@gmail.com +21698409233 Rue Mohamed Karoui
City Postal code Country Position/Affiliation
Sousse Tunisia Medical doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No particular Individual participant data will be available nor shared. You may find the study protocol available. All data will be available upon data collection and analysis which will be made anonymously. Results will be published in the form of an article as well as the study protocol. Study Protocol 1 year Controlled upon request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/02/2023 I added the ethics document as recommended TRUE, Ethics committee of sahloul university hospital, Sahloul , Sousse , 4054, Tunisia, , 01 Sep 2022, +21673369411, sahbichalbi.sc@gmail.com, TRUE, Ethics committee of sahloul university hospital, Sahloul , Sousse , 4054, Tunisia, , 01 Sep 2022, +21673369411, sahbichalbi.sc@gmail.com, 24247_21004_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/02/2023 I forgot to add the file TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 01 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/02/2023 This the only ethics appoval form that i can receive from the ethics committee of Sahloul University Hospital. I will be very grateful to have more explanations about i have to add. TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 01 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 01 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/02/2023 This the only ethics appoval form that i can receive from the ethics committee of Sahloul University Hospital. I will be very grateful to have more explanations as well as for what i have to write in the reporting section. Thank you very much for your assistance ! TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 01 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 01 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/07/2023 I added the appropriate ethical approval TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 01 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf TRUE, Ethics Committee of Sahloul University Hospital, Rue de ceinture Sahloul, Sousse, 4054, Tunisia, , 22 Apr 2022, +21653621154, ajmichaouch@yahoo.fr, 24247_23154_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/01/2023 In response to your comments, i had to specify that status. Principal Investigator, Sahloul , Sousse, , Tunisia, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 04/01/2023 In response to reviewer comments We did not start with the intervention. we are still at the stage of recruiting. Individual participant data will not be available. What data in particular will be shared? Not available What other documents will be available? Study protocol When will data be available (start and end dates)? Not available With Whom? Not applicable For what types of analyses? Not applicable By what mechanism will data be made available? Not applicable
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 21/02/2023 I wrote the IPD description in my own words. Individual participant data will not be available. What data in particular will be shared? Not available What other documents will be available? Study protocol When will data be available (start and end dates)? Not available With Whom? Not applicable For what types of analyses? Not applicable By what mechanism will data be made available? Not applicable No particular Individual participant data will be available nor shared. You may find the study protocol available. All data will be available upon data collection and analysis which will be made anonymously. Results will be published in the form of an article as well as the study protocol.