Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187025
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-12-15
Brief Title:
Addiction Stroke
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Addiction in the Secondary Prevention of Stroke
Status:
RECRUITING
Status Verified Date:
2024-02
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:
ADDICT-STROKE
Brief Summary:
Modifiable stroke risk-factors which include poor lifestyle habits account for 90 of the risk of stroke Disability Adjusted Life Years DALYs related to cerebrovascular disorders rely on three main factors including the severity of stroke-related symptoms the occurrence of stroke complications and stroke recurrences
Stroke complications and the risk of stroke recurrence are highly dependent on the control of vascular risk factors Thus the secondary prevention of stroke involves profound lifestyle modifications including substance use cessation and diet changes
Stroke complications and the risk of stroke recurrence are highly dependent on the control of vascular risk factors Thus the secondary prevention of stroke involves profound lifestyle modifications including substance use cessation and diet changes
Detailed Description:
National guidelines for stroke clinical practice advocate an immediate cessation of consumption of all substances but without recommendations on specific therapeutic regimens Yet the ability to engage and maintain such lifestyle changes depend on the patients mental health status Moreover independently of stroke emotional impairments or disorders and substance related and addiction disorders SRADs are frequent comorbid conditions dual disorders with debilitating consequences and the interplay between the two conditions makes rehabilitation more complex
Post-stroke emotional impairments are frequent post-stroke depression and anxiety being the most frequent with a prevalence of 30 and 25 respectively The consequences of these invisible handicaps are observable across a wide range of stroke clinical outcomes They have been shown to be associated with increased mortality reduced functional status decreased quality of life medication adherence efficient use of rehabilitation services and cognitive impairment
Conversely despite the obvious connection between drugs and stroke the prevalence and types of SRADs among stroke patients together with their impact and potential interplay with emotional impairments on post-stroke outcomes are still overlooked The literature is too sparse to guide clinical practice
Paradoxically clinicians are facing the devastating effects of addiction in this population and must be informed by solid empirical data Moreover the COVID19 pandemic has critically favored or exacerbated poor lifestyle habits legal and illicit drug use compulsive overeating and negative affectivity - including mood and anxiety disorders - not only in the adult but also the adolescent population In this context we believe it is legitimate to expect a noticeable impact on stroke incidence and prognosis in the coming years
It thus appears that there is an urgent need to allow stroke healthcare professionals to be better equipped to screen and treat problematic substance use in stroke patients The WHO promotes tools that could effectively support these two priorities
First the WHO sponsored the development of the Alcohol Smoking and Substance Involvement Screening Test ASSIST to address the need for a reliable and valid screening test The core criteria chosen for the development of such an instrument were the following adaptable to different cultures languages and settings flexible enough to identify different substances and different patterns of substance use capable of screening for risk as well as for confirmed cases ability to link easily into a brief intervention available at a reasonableor no cost Planning and development of the instrument followed a three-phase program the instrument that is currently available is the ASSIST version 3 for which the French language validation has been already conducted among clients attending primary health care psychiatric addiction and geriatric treatment facilities These study findings strongly suggest that the ASSIST tool would be suitable for stroke populations
Additionally the potential pivotal role of eHealth development has been advocated by the WHO who considers e-health as a cost-effective and secure use of information and communication technologies ICT in support of health and health-related fields There is a pressing need to develop such a device for the early detection of post-stroke neuropsychiatric complications for each individual patient The rapid expansion of ambulatory monitoring techniques such as Ecological Momentary Assessment EMA allows daily evaluations of symptoms in real time and in the natural contexts of daily life We have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications Moreover we have developed an Ecological Momentary Intervention via smartphone to improve the outcome of post-stroke emotional status This eHealth device uses algorithms for detecting at-risk patients depending on the level of mood symptomatology DSM5 criteria for depression generalized anxiety post-traumatic stress disorder suicidal risk measured by a daily 3-5 min EMA at the end of the day Data are sent on-line via secured servers and coded alerts are sent to the hospital clinical team in case risk levels are reached andor if high levels of symptom persist This approach permits clinicians to rapidly contact patients and to initiate psychiatric care without requiring the usual 4-month wait on average before the standard care follow-up visit Specifically based on the alerts the care pathway is adapted according to each individual condition The eHealth device is flexible and can be optimized by implementing algorithms and alerts indexing difficulties in controlling substance and unhealthy food intake
Post-stroke emotional impairments are frequent post-stroke depression and anxiety being the most frequent with a prevalence of 30 and 25 respectively The consequences of these invisible handicaps are observable across a wide range of stroke clinical outcomes They have been shown to be associated with increased mortality reduced functional status decreased quality of life medication adherence efficient use of rehabilitation services and cognitive impairment
Conversely despite the obvious connection between drugs and stroke the prevalence and types of SRADs among stroke patients together with their impact and potential interplay with emotional impairments on post-stroke outcomes are still overlooked The literature is too sparse to guide clinical practice
Paradoxically clinicians are facing the devastating effects of addiction in this population and must be informed by solid empirical data Moreover the COVID19 pandemic has critically favored or exacerbated poor lifestyle habits legal and illicit drug use compulsive overeating and negative affectivity - including mood and anxiety disorders - not only in the adult but also the adolescent population In this context we believe it is legitimate to expect a noticeable impact on stroke incidence and prognosis in the coming years
It thus appears that there is an urgent need to allow stroke healthcare professionals to be better equipped to screen and treat problematic substance use in stroke patients The WHO promotes tools that could effectively support these two priorities
First the WHO sponsored the development of the Alcohol Smoking and Substance Involvement Screening Test ASSIST to address the need for a reliable and valid screening test The core criteria chosen for the development of such an instrument were the following adaptable to different cultures languages and settings flexible enough to identify different substances and different patterns of substance use capable of screening for risk as well as for confirmed cases ability to link easily into a brief intervention available at a reasonableor no cost Planning and development of the instrument followed a three-phase program the instrument that is currently available is the ASSIST version 3 for which the French language validation has been already conducted among clients attending primary health care psychiatric addiction and geriatric treatment facilities These study findings strongly suggest that the ASSIST tool would be suitable for stroke populations
Additionally the potential pivotal role of eHealth development has been advocated by the WHO who considers e-health as a cost-effective and secure use of information and communication technologies ICT in support of health and health-related fields There is a pressing need to develop such a device for the early detection of post-stroke neuropsychiatric complications for each individual patient The rapid expansion of ambulatory monitoring techniques such as Ecological Momentary Assessment EMA allows daily evaluations of symptoms in real time and in the natural contexts of daily life We have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications Moreover we have developed an Ecological Momentary Intervention via smartphone to improve the outcome of post-stroke emotional status This eHealth device uses algorithms for detecting at-risk patients depending on the level of mood symptomatology DSM5 criteria for depression generalized anxiety post-traumatic stress disorder suicidal risk measured by a daily 3-5 min EMA at the end of the day Data are sent on-line via secured servers and coded alerts are sent to the hospital clinical team in case risk levels are reached andor if high levels of symptom persist This approach permits clinicians to rapidly contact patients and to initiate psychiatric care without requiring the usual 4-month wait on average before the standard care follow-up visit Specifically based on the alerts the care pathway is adapted according to each individual condition The eHealth device is flexible and can be optimized by implementing algorithms and alerts indexing difficulties in controlling substance and unhealthy food intake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None