Substance-Related DisordersHAPEXNCT04458987
Addictology Expert Patients' Fields of Intervention
A study testing Expert patient in addictology in people with Substance-Related Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Although there are many publications concerning the benefit of the interventions of the self-help movements and peer health mediators in psychiatry, no studies have described the intervention specific to patients with expertise in addictology (EP), nor evaluated their effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Expert patient in addictology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2020to 19 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal.
- Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria.
- Patients who have received information about the research and signed the consent form.
Who cannot join
- Severe cognitive impairment i.e. MoCA scale < or = 10
- Severe psychiatric conditions assessed using the MINI scale : Acute psychotic episode, Manic or hypomaniacal episode, Severe depression
- non comprehension of french
- patient Under guardianship or curatorship
- patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Département psychiatrie et addictologie Bichat Claude Bernard
Paris, 75018
About this study
Official title: Identification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders
Although there are many publications concerning the benefit of the interventions of the self-help movements and peer health mediators in psychiatry, no studies have described the intervention specific to patients with expertise in addictology (EP), nor evaluated their effectiveness.
The objective of this study is twofold: identify and define the fields of intervention of EPs adapted to the specific needs of addictology patients. And validate, through a pilot study, the intermediate effectiveness of EP intervention. This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. The first part of the study will consist of a preliminary qualitative patient-centered study to clarify patients' needs and expectations regarding the content of the EPs' intervention into a one addictology service of the university hospital of Bichat, Paris, France. This will make it possible to translate these needs into fields of expertise to address during the EPs' intervention and will result in the creation of a hetero-questionnaire. The second part of the study will consist of a before-and-after comparative study on inpatients who are their own controls based on the hetero-questionnaire constructed through the qualitative study.
This study will identify the main EP's intervention fields in addictology in which EP are more relevant to patients. Thus, their inpatient interventions can be validated and improved, and better carried by addiction professionals.
Read the detailed description
- Targeted population : Major individuals hospitalized in the Department of Addictology and Psychiatry at Bichat Hospital. All participants sign a hospitalization contract upon arrival in which they undertake, among other things, to meet with the EP, within the framework of a system set up in the hospitalization unit since 2015. In order to be able to study the different factors influencing the intervention mechanism, it is decided to take the broadest possible selection criteria in order to remain representative of the heterogeneity of the target population. This is why the investigators have chosen to include all hospitalized patients in the service who agree to meet with an EP, at all socio-economic levels, for withdrawal from any substance regardless of the severity of the addictive disorder, regardless of the previous course of care with or without anxiety and depression symptoms
- Inclusion criteria : Adults, hospitalized during the period of inclusion of the study in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal. Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria. Patients who have received information about the research and signed the consent form.
- Non inclusion criteria : Severe cognitive disorders, i.e. MoCA test < 11, Severe psychiatric disorders assessed using the MINI test (acute psychotic episode, manic or hypomanic episode, severe depression), No understanding of French, Patient under guardianship or curatorship, Patient refusal
- Study conduct : STEP 1: Preliminary qualitative study
- among the first eligible patients in the study to specify the content of EP's intervention, adapted to the inpatient's needs
- Individual face-to-face interview, conducted by the principal investigator (PI) , according to the methodology socio-anthropological interviews
- The interview will be conducted during the patient's hospitalization, whether the patient has already met with the EP or not.
- Number of participants expected is not decided, the PI waiting for the saturation of information as it happens as the interviews progressed
- A semi-structured interview grid will be followed
- The interviews will be recorded and transcribed in the form of verbatim and then analyzed according to the content analysis technique
- This analysis will be supervised by a socio- anthropologist from the research team of Robert Debré
- The needs of patients will be produced by this analysis, and will be translated into fields of skills to be addressed during the EP's intervention
- End of the study for these first participants STEP 2: Before and after comparative study on inpatients being their own witnesses. This is a study feasibility pilot
- Eligible participants will be patients meeting the criteria for judgment and not having not participated in the first part of the study
- They will be presented with the study and the collection of the consent at the beginning of hospitalization, before the EP's intervention
- After agreement of participation, the initial socio-economic participants' characteristics will be collected on the variable collection notebook
- Completion of the first competency assessment hetero-questionnaire before the EP's intervention (main criterion judgment evaluation). This questionnaire will have been constructed based on patient needs expressed in Part 1
- EP's Intervention, with patients hospitalized for withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients.
- The second hetero-questionnaire will be proposed to the same patient during his hospitalization, within 48 hours of the EP's intervention (main criterion judgment evaluation)
- A follow-up (by telephone or in person) will be carried out at 1 month and then 3 months to estimate the number of patients who have consumed during the hospitalization (frequency, quantity, duration)
- End of the study for a patient
- Inclusion : For the qualitative study, the investigators estimate that the data are saturated between 10 and 20 patients. For the quantitative study, the investigators estimate that there are 10 new patients per month. The investigators hope to include at least half of the target population, meaning 50 participants over the 10 months of the study. In total, for the entire study, an estimate of 70 participants.
- Statistics analysis : The statistical analysis will be performed using SAS v9.3®. The quantitative variables will be presented as median, interquartile and missing data. The qualitative variables will be presented in terms of frequency, percentage and number of missing data. The initial characteristics of the patients will be presented. The indicators qualitative and quantitative acceptability will also be presented. The median of the results of the competency questionnaires between D0 and H48 will be compared between the group before and after by a Wilcoxon test (no hypothesis on the distribution of this variable). A multivariate analysis will be conducted to identify all the factors influencing the variation in questionnaire responses. This will allow the influence of patient profiles on outcomes to be taken into account.
- Conditions
- Substance-Related Disorders
- Being tested
- Expert patient in addictology
- Keywords
- expert patients, addictology, withdrawal, addiction
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert patient in addictologyBehavioural
EP's Intervention, with patients hospitalized for addiction withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients.
The content of the intervention will be defined trough the results of step one of the study.
| Study group | Role | What they receive |
|---|---|---|
| Expert patient in addictology | Experimental | before/ after comparison, each patients being its own control Receives: Behavioral: Expert patient in addictology |
What is being measured
The primary outcome is the main question the study is designed to answer.
median of the difference of the score of the competency questionnaires between D0 and H48 will be compared between the group before and the group after
This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. This will be measured by a hetero-questionnaire, created by the first part of the study, evaluating the skills acquired by patients before and after this intervention. As this is a new scale created thanks to the forst part of the study, the investigators don't know what will be the minimum, the maximum or/and the relation between the score and the outcome
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start19 Jun 2020
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients hospitalized for addiction withdrawal in the addiction service of the university hospital Bichat, Paris, France
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chanaëlle OBADIA, MD, Principal investigator, APHPAurélie BOURMAUD, PhD, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458987
- Sponsor's protocol ID
- APHP190489
- Acronym
- HAPEX
- Status last verified
- Oct 2020
- First submitted
- 27 Jan 2020
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders
- ClinicalTrials.gov ID
- NCT04458987
- Acronym / sponsor ID
- HAPEX / APHP190489
- Conditions
- Substance-Related Disorders
- Keywords
- expert patients, addictology, withdrawal, addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although there are many publications concerning the benefit of the interventions of the self-help movements and peer health mediators in psychiatry, no studies have described the intervention specific to patients with expertise in addictology (EP), nor evaluated their effectiveness.
The objective of this study is twofold: identify and define the fields of intervention of EPs adapted to the specific needs of addictology patients. And validate, through a pilot study, the intermediate effectiveness of EP intervention. This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. The first part of the study will consist of a preliminary qualitative patient-centered study to clarify patients' needs and expectations regarding the content of the EPs' intervention into a one addictology service of the university hospital of Bichat, Paris, France. This will make it possible to translate these needs into fields of expertise to address during the EPs' intervention and will result in the creation of a hetero-questionnaire. The second part of the study will consist of a before-and-after comparative study on inpatients who are their own controls based on the hetero-questionnaire constructed through the qualitative study.
This study will identify the main EP's intervention fields in addictology in which EP are more relevant to patients. Thus, their inpatient interventions can be validated and improved, and better carried by addiction professionals.
Detailed description
- Targeted population : Major individuals hospitalized in the Department of Addictology and Psychiatry at Bichat Hospital. All participants sign a hospitalization contract upon arrival in which they undertake, among other things, to meet with the EP, within the framework of a system set up in the hospitalization unit since 2015. In order to be able to study the different factors influencing the intervention mechanism, it is decided to take the broadest possible selection criteria in order to remain representative of the heterogeneity of the target population. This is why the investigators have chosen to include all hospitalized patients in the service who agree to meet with an EP, at all socio-economic levels, for withdrawal from any substance regardless of the severity of the addictive disorder, regardless of the previous course of care with or without anxiety and depression symptoms
- Inclusion criteria : Adults, hospitalized during the period of inclusion of the study in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal. Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria. Patients who have received information about the research and signed the consent form.
- Non inclusion criteria : Severe cognitive disorders, i.e. MoCA test < 11, Severe psychiatric disorders assessed using the MINI test (acute psychotic episode, manic or hypomanic episode, severe depression), No understanding of French, Patient under guardianship or curatorship, Patient refusal
- Study conduct : STEP 1: Preliminary qualitative study
- among the first eligible patients in the study to specify the content of EP's intervention, adapted to the inpatient's needs
- Individual face-to-face interview, conducted by the principal investigator (PI) , according to the methodology socio-anthropological interviews
- The interview will be conducted during the patient's hospitalization, whether the patient has already met with the EP or not.
- Number of participants expected is not decided, the PI waiting for the saturation of information as it happens as the interviews progressed
- A semi-structured interview grid will be followed
- The interviews will be recorded and transcribed in the form of verbatim and then analyzed according to the content analysis technique
- This analysis will be supervised by a socio- anthropologist from the research team of Robert Debré
- The needs of patients will be produced by this analysis, and will be translated into fields of skills to be addressed during the EP's intervention
- End of the study for these first participants STEP 2: Before and after comparative study on inpatients being their own witnesses. This is a study feasibility pilot
- Eligible participants will be patients meeting the criteria for judgment and not having not participated in the first part of the study
- They will be presented with the study and the collection of the consent at the beginning of hospitalization, before the EP's intervention
- After agreement of participation, the initial socio-economic participants' characteristics will be collected on the variable collection notebook
- Completion of the first competency assessment hetero-questionnaire before the EP's intervention (main criterion judgment evaluation). This questionnaire will have been constructed based on patient needs expressed in Part 1
- EP's Intervention, with patients hospitalized for withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients.
- The second hetero-questionnaire will be proposed to the same patient during his hospitalization, within 48 hours of the EP's intervention (main criterion judgment evaluation)
- A follow-up (by telephone or in person) will be carried out at 1 month and then 3 months to estimate the number of patients who have consumed during the hospitalization (frequency, quantity, duration)
- End of the study for a patient
- Inclusion : For the qualitative study, the investigators estimate that the data are saturated between 10 and 20 patients. For the quantitative study, the investigators estimate that there are 10 new patients per month. The investigators hope to include at least half of the target population, meaning 50 participants over the 10 months of the study. In total, for the entire study, an estimate of 70 participants.
- Statistics analysis : The statistical analysis will be performed using SAS v9.3®. The quantitative variables will be presented as median, interquartile and missing data. The qualitative variables will be presented in terms of frequency, percentage and number of missing data. The initial characteristics of the patients will be presented. The indicators qualitative and quantitative acceptability will also be presented. The median of the results of the competency questionnaires between D0 and H48 will be compared between the group before and after by a Wilcoxon test (no hypothesis on the distribution of this variable). A multivariate analysis will be conducted to identify all the factors influencing the variation in questionnaire responses. This will allow the influence of patient profiles on outcomes to be taken into account.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients hospitalized for addiction withdrawal in the addiction service of the university hospital Bichat, Paris, France
| Arm | Type | Receives |
|---|---|---|
| Expert patient in addictology | Experimental | Behavioral: Expert patient in addictologybefore/ after comparison, each patients being its own control |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients hospitalized in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal.
- Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria.
- Patients who have received information about the research and signed the consent form.
Key exclusion criteria (5 listed)
- Severe cognitive impairment i.e. MoCA scale < or = 10
- Severe psychiatric conditions assessed using the MINI scale : Acute psychotic episode, Manic or hypomaniacal episode, Severe depression
- non comprehension of french
- patient Under guardianship or curatorship
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert patient in addictologyEP's Intervention, with patients hospitalized for addiction withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients. The content of the intervention will be defined trough the results of step one of the study. | Behavioural | Expert patient in addictology |
Primary outcome
median of the difference of the score of the competency questionnaires between D0 and H48 will be compared between the group before and the group after
Time frame: 48 hours
This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. This will be measured by a hetero-questionnaire, created by the first part of the study, evaluating the skills acquired by patients before and after this intervention. As this is a new scale created thanks to the forst part of the study, the investigators don't know what will be the minimum, the maximum or/and the relation between the score and the outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanaëlle OBADIA, MD principal investigator
APHP
Aurélie BOURMAUD, PhD study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expert patient in addictology in people with Substance-Related Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median of the difference of the score of the competency questionnaires between D0 and H48 will be compared between the group before and the group after (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.