- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04927455
Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability (VITAE)
Pilot Study to Evaluate Impact and Transferability of an Alcohol Focused Harm Reduction Support System Based on Mental Health Recovery Named IACA!
In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial.
This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.
연구 개요
상세 설명
In France, 11% of cancers in men and 4.5% of cancers in women are attributed to alcohol consumption. It is the second leading cause of so-called preventable cancers, accounting for 28,000 alcohol-related cancers out of 352,000 new cases of cancer affecting annually adults (over 30 years of age). Overall, alcohol is among the top 3 factors contributing to Disability-Adjusted life year (DALYs) in France in 2017. Some cancer risks can be quantified as early as one drink a day (oesophagus, oral cavity, pharynx and breast in women). However, the risks associated with alcohol consumption remain influenced by the quantities consumed. There is therefore an interest, particularly for consumers of the largest quantities, in reducing the quantities consumed. In Europe, while people who drink more than 60 g/d of alcohol for men and 40 g/d for women are estimated to represent only 16.1% of the population for men and 9.3% for women, they represent 87% and 82% of alcohol-related morbidity and mortality respectively. Subjects with addiction (or substance use disorders) have an increased risk of social harm (1.5 to 3 times that of alcohol users without addiction), a higher mortality (1.4 to 6.5 compared to the general population) with a life expectancy of 9 to 20 years shorter than that of the general population. Moreover, even if the quantities consumed are not a valid individual diagnostic criterion, studies show a strong association between the quantity consumed and the diagnosis of addiction. Finally, some studies suggest that the prevalence of secondary harm from alcohol use follows an exponential curve as a function of alcohol consumption.
Since 2014, in the PACA region, the association Santé! has been developing an intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! (Integrating and supporting alcohol consumption), differs from the support provided during rehabilitation cures and aims to: fight against discrimination and exclusion of people who drink alcohol, re-engage these individuals in the care process (because they have generally left it) by using the appropriate levers, promote well-being, improve quality of life and recovery and support the recovery in control of consumption. Thus, IACA!, through its philosophy and implementation, is based both on the risk reduction approach historically deployed with drug users and on the recovery approach, developed in the field of mental health. The first one-year results of this program were promising since, of 17 people who received the intervention, all had a social or health benefit, 13 of whom were associated with stabilization (n=4), reduction (n=7) or cessation (n=2) of alcohol use.
These promising results must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial. This type of evaluation requires significant human and material resources. It is therefore recommended to first assess in the field: 1) the conditions under which such an intervention is deployed in other centres (adaptations implemented by other centres to deploy IACA! for example, without distorting the intervention), 2) the acceptability and feasibility of the intervention in other centres (are the human and material resources on site sufficient for the successful deployment of the intervention?), 3) the acceptability and feasibility of the large-scale evaluation envisaged.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Bordeaux, 프랑스
- CH Perrens - Equipe Addiction
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Bordeaux, 프랑스
- MéRISP - Université U1219
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
This research will investigate three types of populations:
- Individuals receiving support from the IACA! Intervention (called beneficiaries),
- Professionals implementing the IACA! Intervention i.e. the pairs in charge of accompanying the beneficiaries in the centers as well as the persons in charge of these centers,
- Professionals from Santé! supporting the deployment of the IACA! intervention.
The beneficiaries are all persons integrating the program in the project's partner sites and consuming alcohol.
The professionals will be specialized educators, social workers, nurses, social and solidarity economy advisors, etc.
설명
Inclusion criteria common to the 3 populations:
- Over 18 years of age
- whatever the gender
- Non-opposition to participate
Inclusion criteria for professionals from centers implementing IACA! :
Concerning professionals in contact with the patients:
- Having been trained at IACA!
- Working in the centers participating in the implementation of IACA!
Concerning the persons in charge of the centers :
These professionals are those who have participated in the deployment of the IACA! method in their centers
Criteria for the inclusion of health professionals ! Participating or having recently participated in the implementation of IACA!
Exclusion Criteria:
The beneficiaries will be excluded if they have a severe somatic or psychiatric pathology that is incompatible with understanding the assessment tools; difficulty understanding and/or writing French; if they are unreachable by telephone, if they are participating in another research project with an ongoing exclusion period, if they are placed under court protection and if they are pregnant.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Severity of alcohol use
기간: 12 months after the start of IACA
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12 months after the start of IACA
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Utility dimension of viability - alcohol consumption
기간: Baseline (M0)
|
Average number of units of alcohol consumption in the past 30 days
|
Baseline (M0)
|
Utility dimension of viability - alcohol consumption
기간: 3 months (M3)
|
Average number of units of alcohol consumption in the past 30 days
|
3 months (M3)
|
Utility dimension of viability - alcohol consumption
기간: 6 months (M6)
|
Average number of units of alcohol consumption in the past 30 days
|
6 months (M6)
|
Utility dimension of viability - alcohol consumption
기간: 9 months (M9)
|
Average number of units of alcohol consumption in the past 30 days
|
9 months (M9)
|
Utility dimension of viability - alcohol consumption
기간: 12 months (M12)
|
Average number of units of alcohol consumption in the past 30 days
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12 months (M12)
|
Utility dimension of viability - craving
기간: Baseline (M0)
|
Craving: average frequency and intensity in the last 30 days
|
Baseline (M0)
|
Utility dimension of viability - craving
기간: 3 months (M3)
|
Craving: average frequency and intensity in the last 30 days
|
3 months (M3)
|
Utility dimension of viability - craving
기간: 6 months (M6)
|
Craving: average frequency and intensity in the last 30 days
|
6 months (M6)
|
Utility dimension of viability - craving
기간: 9 months (M9)
|
Craving: average frequency and intensity in the last 30 days
|
9 months (M9)
|
Utility dimension of viability - craving
기간: 12 months (M12)
|
Craving: average frequency and intensity in the last 30 days
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12 months (M12)
|
Utility dimension of viability - severity
기간: Baseline (M0)
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Severity score for addictive substances and behaviors
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Baseline (M0)
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Utility dimension of viability - severity
기간: 3 months (M3)
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Severity score for addictive substances and behaviors
|
3 months (M3)
|
Utility dimension of viability - severity
기간: 6 months (M6)
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Severity score for addictive substances and behaviors
|
6 months (M6)
|
Utility dimension of viability - severity
기간: 9 months (M9)
|
Severity score for addictive substances and behaviors
|
9 months (M9)
|
Utility dimension of viability - severity
기간: 12 months (M12)
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Severity score for addictive substances and behaviors
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12 months (M12)
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Utility dimension of viability - disorders
기간: Baseline (M0)
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Presence of alcohol and other substance use disorders (past 12 months and past)
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Baseline (M0)
|
Utility dimension of viability - disorders
기간: 3 months (M3)
|
Presence of alcohol and other substance use disorders (past 12 months and past)
|
3 months (M3)
|
Utility dimension of viability - disorders
기간: 6 months (M6)
|
Presence of alcohol and other substance use disorders (past 12 months and past)
|
6 months (M6)
|
Utility dimension of viability - disorders
기간: 9 months (M9)
|
Presence of alcohol and other substance use disorders (past 12 months and past)
|
9 months (M9)
|
Utility dimension of viability - disorders
기간: 12 months (M12)
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Presence of alcohol and other substance use disorders (past 12 months and past)
|
12 months (M12)
|
Utility dimension of viability - Other substances
기간: Baseline (M0)
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Number of days of use of other substances/behaviours in the past 30 days
|
Baseline (M0)
|
Utility dimension of viability - Other substances
기간: 3 months (M3)
|
Number of days of use of other substances/behaviours in the past 30 days
|
3 months (M3)
|
Utility dimension of viability - Other substances
기간: 6 months (M6)
|
Number of days of use of other substances/behaviours in the past 30 days
|
6 months (M6)
|
Utility dimension of viability - Other substances
기간: 9 months (M9)
|
Number of days of use of other substances/behaviours in the past 30 days
|
9 months (M9)
|
Utility dimension of viability - Other substances
기간: 12 months (M12)
|
Number of days of use of other substances/behaviours in the past 30 days
|
12 months (M12)
|
Utility dimension of viability - Inventory
기간: Baseline (M0)
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Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
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Baseline (M0)
|
Utility dimension of viability - Inventory
기간: 3 months (M3)
|
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
|
3 months (M3)
|
Utility dimension of viability - Inventory
기간: 6 months (M6)
|
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
|
6 months (M6)
|
Utility dimension of viability - Inventory
기간: 9 months (M9)
|
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
|
9 months (M9)
|
Utility dimension of viability - Inventory
기간: 12 months (M12)
|
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
|
12 months (M12)
|
Utility dimension of viability - QoL
기간: Baseline (M0)
|
Quality of life
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Baseline (M0)
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Utility dimension of viability - QoL
기간: 3 months (M3)
|
Quality of life
|
3 months (M3)
|
Utility dimension of viability - QoL
기간: 6 months (M6)
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Quality of life
|
6 months (M6)
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Utility dimension of viability - QoL
기간: 9 months (M9)
|
Quality of life
|
9 months (M9)
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Utility dimension of viability - QoL
기간: 12 months (M12)
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Quality of life
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12 months (M12)
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Conditions of transferability
기간: 9 to 12 months (M9 to M12)
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Conditions of transferability linked to the characteristics of the stakeholders and the context: contextual conditions for success within the centres, the characteristics of professionals and patients influencing outcomes
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9 to 12 months (M9 to M12)
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Viability and implementation
기간: 6 to 12 months (M6 to M12)
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Implementation of IACA! (process, resources, activities) including the respect of IACA! success principles (skills, postures)
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6 to 12 months (M6 to M12)
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Viability and utility
기간: 6 to 12 months (M6 to M12)
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"utility" dimension (as a complement to the secondary criteria) of viability through the recovery mechanisms identified as successful mental health recovery
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6 to 12 months (M6 to M12)
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Viability and affordability
기간: 6 to 12 months (M6 to M12)
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Affordability for professionals and beneficiaries (financial, geographical, social and cultural levers and brakes of the intervention)
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6 to 12 months (M6 to M12)
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Viability and evaluability
기간: 6 to 12 months (M6 to M12)
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Evaluability of IACA: carrying out this evaluation, the availability of professionals and beneficiaries to answer questionnaires and interviews, missing data in the questionnaires etc.
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6 to 12 months (M6 to M12)
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Viability and adaptability
기간: 6 to 12 months (M6 to M12)
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Adaptability of IACA! (integration of the action into the context and the current organisation of the centres)
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6 to 12 months (M6 to M12)
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Viability and acceptability
기간: 6 to 12 months (M6 to M12)
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Acceptability of IACA! by professionals and beneficiaries
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6 to 12 months (M6 to M12)
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Feasibility study capacity
기간: 12 months (M12)
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The centres' capacity for inclusion (eligibility, recruitment rate, refusal rate)
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12 months (M12)
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Feasibility study complicance
기간: 12 months (M12)
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The compliance rates; understanding, acceptability and feasibility of study questionnaires and data collection tools;
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12 months (M12)
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Feasibility study ressources
기간: 12 months (M12)
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The ressources required (time required to complete all study forms, professional/centre capacity, etc.)
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12 months (M12)
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공동 작업자 및 조사자
수사관
- 연구 의자: Linda Cambon, PhD, Bordeaux University Hospital, Bordeaux University U1219
- 연구 책임자: François Alla, MD, PhD, Bordeaux University Hospital, Bordeaux University U1219
- 연구 책임자: Marc Auriacombe, MD, PhD, CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University
간행물 및 유용한 링크
일반 간행물
- Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L, Nour K, Blaise P, Charlesworth J, Alla F; Discussion Panel. Population health intervention research: what is the place for pilot studies? Trials. 2019 May 30;20(1):309. doi: 10.1186/s13063-019-3422-4.
- Cambon L, Minary L, Ridde V, Alla F. Transferability of interventions in health education: a review. BMC Public Health. 2012 Jul 2;12:497. doi: 10.1186/1471-2458-12-497.
- Martin-Fernandez J, Stevens N, Moriceau S, Serre F, Blanc H, Latourte E, Auriacombe M, Cambon L. Realist evaluation of the impact, viability and transferability of an alcohol harm reduction support programme based on mental health recovery: the Vitae study protocol. BMJ Open. 2022 Aug 11;12(8):e065361. doi: 10.1136/bmjopen-2022-065361.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CHUBX 2020/35
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