Ignite Creation Date:
2024-05-06 @ 7:24 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02522182
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-18
First Post:
2015-07-21
Brief Title:
ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome ALLEPRE
Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Organization:
Azienda Ospedaliero-Universitaria di Parma
Study Overview
Official Title:
ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome The ALLEPRE Trial a Fully Nurse-led Intensive Intervention Programme
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLEPRE
Brief Summary:
The purpose of the ALLEPRE trial is to compare the benefit offered by a structured intensive and fully nurse-led intensive secondary prevention intervention programme with that offered by standard of care in a high-risk population of patients admitted to hospital because of an ACS
Detailed Description:
ALLEPRE enrols a population of residents in Emilia Romagna with a diagnosis of ACS unstable angina non-ST segment elevation myocardial infarction ST segment elevation myocardial infarction who were admitted to the specialist cardiological departments of the participating centres up to 20 days after the index event
All eligible patients are randomised 11 to the nurse-led intensive secondary prevention programme ISPP interventionexperimental arm or usual treatment UT control arm
Randomisation is centralised by means of IVRS under the responsibility of the Study Coordinator and the Principal Investigator at each hospital centre and the patients are the allocated to groups by e-mail Due to the nature of the study neither participants nor research personnel can be blinded to the group assignments The randomisation data are kept at the coordinating centre
OPERATIVE PHASE After randomisation all of the patients in both arms undergo a baseline examination and are required to return to their reference centre for follow-up visits after 12 24 and 60 months for outcome assesment Outcomes will also be recorded after 36 and 48 months on the basis of telephone enquiries
ISPP intervention arm This consists of a series of programmed sessions involving the centrally trained nurses and the patients randomised to the ISPP There will be a total of nine sessions before discharge and one three six 12 18 24 36 and 48 months after discharge During the sessions each of which will last for about one hour the trained nurse will record the main clinical parameters ie risk factors lifestyle habits adherence to therapy and any discrepancies between patient reports and the recommended goals using an ad hoc clinical file SIM scheda infermieristica multidimensionale or multidimensional nursing form and then activate the interventions laid down by the pre-specified rules inside the SIM in order to correct the discrepancies The activation of the pre-established multidisciplinary network anti-smoking anti-diabetes and anti-hypertension centres and psychological support is completely under the nurses control
Caregivers are encouraged to support the patients in achieving behavioural changes over time
Adherence to the proven secondary prevention treatments is monitored using the Morisky scale in order to ensure that each of the following classes of cardioprotective medications are prescribed according to the guidelines at the doses used in clinical trials antiplatelet therapy beta-blockers angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and statins The reasons for non-adherence also investigated in order to ensure more targeted interventions The risk factor and lifestyle behaviour goals are to stop smoking eat a healthy Mediterranean diet undertake physical activity for at least 30 minutesday on five daysweek and maintain a body mass index BMI of 25 kgm2 systolic blood pressure of 140 LDL cholesterol levels of 70 mgdL 181 mmolL A further goal for all diabetic subjects is good glycemic control
The nurses also assess the subjects psychological characteristics by means of a questionnaire that measures anxiety depression anger and hostility type A and type D personality perceived social support and perceived self-efficacy and use an ad hoc questionnaire for referral to a psychologist if necessary
To ensure the same nurse intervention in all partecipating centers the study started with a preliminary TRAINING PHASE involving professional nurses proposed by the participating centres 6-10 per centre 50 from a hospital setting 50 from a community setting The training programme was coordinated by the Training and Continuous Education Centre of Parma University Hospital and delivered by a multidisciplinary team of medicalnursingpsychological experts with the aid of ad hoc paper-based teaching materials It consisted of three 8-hour sessions held on consecutive days during which the nurses were trained in secondary CVD prevention and how to take multi-dimensional and structured responsibility for ACS patients using appropriate communication strategies aimed at reducing risk factors modifying lifestyles and improving adherence to prescribed pharmacological therapy The programme was repeated four times in order to allow the creation of small groups 20 participants and better interactions
UT control arm The patients randomised to the control group will follow the standard for secondary prevention of the hospital to which they were admitted
DATA MANAGEMENT All of the data are peripherally recorded in electronic case report forms and stored for further analysis An external monitoring provides for all partecipating centrers the clinical data verification the accuracy and the completeness of electronic case report forms
Sample size and statistical aspects On the basis of the results of the GRACE UK-Belgian Study it is conservatively expected that the cumulative rate of clinical endpoints in the standard care arm cardiovascular mortality non-fatal reinfarction non-fatal stroke during the five years follow-up will be 28 Using the formula of Lakatos and Lan Statistics in Medicine 1992 in order to detect a 25 risk reduction in the experimental group with 90 power and a two-sided significance level of 025 at least 1030 patients are required in each group
However a two-year interim analysis of the major clinical endpoint will show the real divergence of the curves and provide further information for estimating the required duration of the study more precisely The estimated sample size is also valid for the analysis of the first primary endpoint
The plan of the primary and secondary analyses includes a Kaplan-Meier analysis of the time to an event the HR and log-rank comparisons based on the ITT and PP populations
The baseline characteristics of the intervention and control group will be compared using the chi-squared test for categorical factors and Students t test for independent samples for continuous factors The data will be expressed as mean values standard deviations All of the statistical analyses will be made using the SPSS programme
A secondary heterogeneity analysis of the primary clinical outcomes will be made by stratifying the patients by age sex center literacy level diabetes hypertension smoking habits family history type of myocardial infarction STEMI vs NSTEMI and hospital characteristics Analysis of repeated measures will be used to evaluate the changes in the primary surrogate end point over time
All eligible patients are randomised 11 to the nurse-led intensive secondary prevention programme ISPP interventionexperimental arm or usual treatment UT control arm
Randomisation is centralised by means of IVRS under the responsibility of the Study Coordinator and the Principal Investigator at each hospital centre and the patients are the allocated to groups by e-mail Due to the nature of the study neither participants nor research personnel can be blinded to the group assignments The randomisation data are kept at the coordinating centre
OPERATIVE PHASE After randomisation all of the patients in both arms undergo a baseline examination and are required to return to their reference centre for follow-up visits after 12 24 and 60 months for outcome assesment Outcomes will also be recorded after 36 and 48 months on the basis of telephone enquiries
ISPP intervention arm This consists of a series of programmed sessions involving the centrally trained nurses and the patients randomised to the ISPP There will be a total of nine sessions before discharge and one three six 12 18 24 36 and 48 months after discharge During the sessions each of which will last for about one hour the trained nurse will record the main clinical parameters ie risk factors lifestyle habits adherence to therapy and any discrepancies between patient reports and the recommended goals using an ad hoc clinical file SIM scheda infermieristica multidimensionale or multidimensional nursing form and then activate the interventions laid down by the pre-specified rules inside the SIM in order to correct the discrepancies The activation of the pre-established multidisciplinary network anti-smoking anti-diabetes and anti-hypertension centres and psychological support is completely under the nurses control
Caregivers are encouraged to support the patients in achieving behavioural changes over time
Adherence to the proven secondary prevention treatments is monitored using the Morisky scale in order to ensure that each of the following classes of cardioprotective medications are prescribed according to the guidelines at the doses used in clinical trials antiplatelet therapy beta-blockers angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and statins The reasons for non-adherence also investigated in order to ensure more targeted interventions The risk factor and lifestyle behaviour goals are to stop smoking eat a healthy Mediterranean diet undertake physical activity for at least 30 minutesday on five daysweek and maintain a body mass index BMI of 25 kgm2 systolic blood pressure of 140 LDL cholesterol levels of 70 mgdL 181 mmolL A further goal for all diabetic subjects is good glycemic control
The nurses also assess the subjects psychological characteristics by means of a questionnaire that measures anxiety depression anger and hostility type A and type D personality perceived social support and perceived self-efficacy and use an ad hoc questionnaire for referral to a psychologist if necessary
To ensure the same nurse intervention in all partecipating centers the study started with a preliminary TRAINING PHASE involving professional nurses proposed by the participating centres 6-10 per centre 50 from a hospital setting 50 from a community setting The training programme was coordinated by the Training and Continuous Education Centre of Parma University Hospital and delivered by a multidisciplinary team of medicalnursingpsychological experts with the aid of ad hoc paper-based teaching materials It consisted of three 8-hour sessions held on consecutive days during which the nurses were trained in secondary CVD prevention and how to take multi-dimensional and structured responsibility for ACS patients using appropriate communication strategies aimed at reducing risk factors modifying lifestyles and improving adherence to prescribed pharmacological therapy The programme was repeated four times in order to allow the creation of small groups 20 participants and better interactions
UT control arm The patients randomised to the control group will follow the standard for secondary prevention of the hospital to which they were admitted
DATA MANAGEMENT All of the data are peripherally recorded in electronic case report forms and stored for further analysis An external monitoring provides for all partecipating centrers the clinical data verification the accuracy and the completeness of electronic case report forms
Sample size and statistical aspects On the basis of the results of the GRACE UK-Belgian Study it is conservatively expected that the cumulative rate of clinical endpoints in the standard care arm cardiovascular mortality non-fatal reinfarction non-fatal stroke during the five years follow-up will be 28 Using the formula of Lakatos and Lan Statistics in Medicine 1992 in order to detect a 25 risk reduction in the experimental group with 90 power and a two-sided significance level of 025 at least 1030 patients are required in each group
However a two-year interim analysis of the major clinical endpoint will show the real divergence of the curves and provide further information for estimating the required duration of the study more precisely The estimated sample size is also valid for the analysis of the first primary endpoint
The plan of the primary and secondary analyses includes a Kaplan-Meier analysis of the time to an event the HR and log-rank comparisons based on the ITT and PP populations
The baseline characteristics of the intervention and control group will be compared using the chi-squared test for categorical factors and Students t test for independent samples for continuous factors The data will be expressed as mean values standard deviations All of the statistical analyses will be made using the SPSS programme
A secondary heterogeneity analysis of the primary clinical outcomes will be made by stratifying the patients by age sex center literacy level diabetes hypertension smoking habits family history type of myocardial infarction STEMI vs NSTEMI and hospital characteristics Analysis of repeated measures will be used to evaluate the changes in the primary surrogate end point over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None