SchizophrenicsASMASSNCT03917355
Nonverbal Synchrony, Therapeutic Alliance and Treatment Engagement in First Episode Schizophrenia
An observational study of Schizophrenics, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. This project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenics
- What is being tested?
- Nonverbal synchrony, therapeutic alliance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to 16 Oct 2020
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with a first psychotic episode
Who may be able to join
- Patients after hospitalisation for a first psychotic episode (OMS criteria 1992)
- Patients fluent in French (spoken and written)
- Age ≥ 18 years and < 50 years
- signed informed consent
- participation noted in medical files.
Who cannot join
- Inpatients
- History of brain trauma
- History of neurological disease
- Current Electro-convulsive-treatment
- Drug abuse and dependence (except for tabacco and cannabis)
- Pregnant/breast feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Link Between Patient/Psychiatrist Motor Synchronization and Treatment Adhesion in Patients With First Psychotic Episode, ASMASS Project
The quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. This project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. Psychiatrist/patient interpersonal motor synchronization is a reliable index of therapeutic alliance and a predictor of psychotherapy effectiveness. This project aims to show a link between psychiatrist and patient motor synchrony and treatment adherence. This link could be explained by an association between therapeutic alliance and motor synchronization.
Read the detailed description
Several studies have highlighted the utmost importance of initial medical and psychosocial support during a first psychotic episode. Recent research has shown that non-verbal communication and particularly interpersonal motor synchronization between the patient and his psychiatrist is a key factor in therapeutic alliance. However, such hypothesis have never been tested in terms of treatment adherence neither in a first psychotic episode, nor during a 6-month follow-up. By measuring the interpersonal motor synchronization between the patient and psychiatrist during a video recorded interview at inclusion, month-3 and month-6, the project aims to validate the hypothesis that a high level of interpersonal synchronization should be associated with a high level of therapeutic alliance. This therapeutic alliance being hypothesized as a mediator between synchronization and treatment adherence, the project should show for the first time in a first psychotic episode that the use of reliable and objective variables extracted from the analysis of the synchronization between psychiatrist and patient allows to predict the outcome of therapeutic and treatment alliance.
- Conditions
- Schizophrenics
- Being tested
- Nonverbal synchrony, therapeutic alliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonverbal synchrony, therapeutic allianceBehavioural
Association between motor synchronisation in psychiatrist/patient dyad and patient therapeutic adherence in patients with a first psychotic episode will be measured, 6 months after the first post hospitalisation consultation, using video without sound. Nonverbal synchrony, therapeutic alliance and treatment will evaluated.In this purpose, videos of patients and psychiatrist will be made (for all patients included), and the images will be analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of therapeutic compliance
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).
Measured: Baseline
Scale of therapeutic compliance
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).
Measured: 3 months
Scale of therapeutic compliance
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).
Measured: 6 months
Secondary outcomes (24)
Therapeutic alliance
It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand.
Measured: Baseline
Therapeutic alliance
It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand.
Measured: 3 months
Therapeutic alliance
It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand.
Measured: 6 months
Positive and Negative Symptom Scale
The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210).
Measured: Baseline
Positive and Negative Symptom Scale
The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210).
Measured: 3 months
Positive and Negative Symptom Scale
The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210).
Measured: 6 months
Clinical Assessment Interview for Negative Symptoms
CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview.
Measured: Baseline
Clinical Assessment Interview for Negative Symptoms
CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview.
Measured: 3 months
Clinical Assessment Interview for Negative Symptoms
CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview.
Measured: 6 months
Functioning Remission of General Schizophrenia
The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (α=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning.
Measured: Baseline
Functioning Remission of General Schizophrenia
The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (α=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning.
Measured: 3 months
Functioning Remission of General Schizophrenia
The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (α=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning.
Measured: 6 months
French National Adult Reading Test
The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon \& Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ.
Measured: Baseline
French National Adult Reading Test
The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon \& Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ.
Measured: 3 months
French National Adult Reading Test
The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon \& Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ.
Measured: 6 months
California Verbal Learning Test
The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160).
Measured: Baseline
California Verbal Learning Test
The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160).
Measured: 3 months
California Verbal Learning Test
The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160).
Measured: 6 months
Trail Making Test
This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1.
Measured: Baseline
Trail Making Test
This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1.
Measured: 3 months
Trail Making Test
This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1.
Measured: 6 months
Energy Motion Analysis
Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation.
Measured: Baseline
Energy Motion Analysis
Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation.
Measured: 3 months
Energy Motion Analysis
Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start15 Jul 2019
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophrenicsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917355
- Sponsor's protocol ID
- RECHMPL18_0070
- Acronym
- ASMASS
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2019
- Last updated
- 8 Jul 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Link Between Patient/Psychiatrist Motor Synchronization and Treatment Adhesion in Patients With First Psychotic Episode, ASMASS Project
- ClinicalTrials.gov ID
- NCT03917355
- Acronym / sponsor ID
- ASMASS / RECHMPL18_0070
- Conditions
- Schizophrenics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 17 Apr 2019 (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.
The quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. This project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. Psychiatrist/patient interpersonal motor synchronization is a reliable index of therapeutic alliance and a predictor of psychotherapy effectiveness. This project aims to show a link between psychiatrist and patient motor synchrony and treatment adherence. This link could be explained by an association between therapeutic alliance and motor synchronization.
Detailed description
Several studies have highlighted the utmost importance of initial medical and psychosocial support during a first psychotic episode. Recent research has shown that non-verbal communication and particularly interpersonal motor synchronization between the patient and his psychiatrist is a key factor in therapeutic alliance. However, such hypothesis have never been tested in terms of treatment adherence neither in a first psychotic episode, nor during a 6-month follow-up. By measuring the interpersonal motor synchronization between the patient and psychiatrist during a video recorded interview at inclusion, month-3 and month-6, the project aims to validate the hypothesis that a high level of interpersonal synchronization should be associated with a high level of therapeutic alliance. This therapeutic alliance being hypothesized as a mediator between synchronization and treatment adherence, the project should show for the first time in a first psychotic episode that the use of reliable and objective variables extracted from the analysis of the synchronization between psychiatrist and patient allows to predict the outcome of therapeutic and treatment alliance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a first psychotic episode
Key inclusion criteria (5 listed)
- Patients after hospitalisation for a first psychotic episode (OMS criteria 1992)
- Patients fluent in French (spoken and written)
- Age ≥ 18 years and < 50 years
- signed informed consent
- participation noted in medical files.
Key exclusion criteria (6 listed)
- Inpatients
- History of brain trauma
- History of neurological disease
- Current Electro-convulsive-treatment
- Drug abuse and dependence (except for tabacco and cannabis)
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 |
|---|---|---|
| Nonverbal synchrony, therapeutic allianceAssociation between motor synchronisation in psychiatrist/patient dyad and patient therapeutic adherence in patients with a first psychotic episode will be measured, 6 months after the first post hospitalisation consultation, using video without sound. Nonverbal synchrony, therapeutic alliance and treatment will evaluated.In this purpose, videos of patients and psychiatrist will be made (for all patients included), and the images will be analyzed. | Behavioural | – |
Primary outcome
Scale of therapeutic compliance
Time frame: Baseline
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).
Scale of therapeutic compliance
Time frame: 3 months
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).
Scale of therapeutic compliance
Time frame: 6 months
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).
24 secondary outcomes
Therapeutic alliance
Time frame: Baseline
Therapeutic alliance
Time frame: 3 months
Therapeutic alliance
Time frame: 6 months
Positive and Negative Symptom Scale
Time frame: Baseline
Positive and Negative Symptom Scale
Time frame: 3 months
Positive and Negative Symptom Scale
Time frame: 6 months
Clinical Assessment Interview for Negative Symptoms
Time frame: Baseline
Clinical Assessment Interview for Negative Symptoms
Time frame: 3 months
Clinical Assessment Interview for Negative Symptoms
Time frame: 6 months
Functioning Remission of General Schizophrenia
Time frame: Baseline
Functioning Remission of General Schizophrenia
Time frame: 3 months
Functioning Remission of General Schizophrenia
Time frame: 6 months
French National Adult Reading Test
Time frame: Baseline
French National Adult Reading Test
Time frame: 3 months
French National Adult Reading Test
Time frame: 6 months
California Verbal Learning Test
Time frame: Baseline
California Verbal Learning Test
Time frame: 3 months
California Verbal Learning Test
Time frame: 6 months
Trail Making Test
Time frame: Baseline
Trail Making Test
Time frame: 3 months
Trail Making Test
Time frame: 6 months
Energy Motion Analysis
Time frame: Baseline
Energy Motion Analysis
Time frame: 3 months
Energy Motion Analysis
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenics, run by University Hospital, Montpellier 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Jul 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 was stopped early (reason given: Covid-19). Results are not available in the source record.
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?
Scale of therapeutic compliance (time frame: Baseline). The study lists 3 primary outcomes in all. 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 8 Jul 2021.