Osteopathic MedicineNCT05135780
The Quality of Life in Children at Social Risk, a Case Series Study Protocol
An observational study of Osteopathic Medicine and Effectiveness, run by Francesco Cerritelli at 1 site in Spain.
Trial summary
this case series study has the aim to observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Osteopathic Medicine, Effectiveness
- What is being tested?
- Osteopathic manual treatment and Social education
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 30 Jun 2022
- 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 6 to 12 years
- All sexes
- Child
Study population: * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account
Who may be able to join
- The children will be selected from the set of users of the Albert Foundation with the following criteria:
- Children from families at social risk, in school and aged between 6 and 12 years of age. The situation of social risk or vulnerability will be determined by the "Instrument de cribratge de les situacions de risc i de desemparament" of the General Directorate of Child Care (DGAIA) of the Generalitat de Catalunya (41), being referred by Social Services, other social entities or that have requested assistance directly.
Who cannot join
- ○ Families who do not sign consent to participate in the study.
- The unavailability of families to participate in the study. In some cases, even if there are children who meet the inclusion criteria, they may not have the capacity to participate for reasons outside the AF or/or personal.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Sonia Roura Carvajal
La Seu d'Urgell, 25700
Sonia Roura Carvajal, 619789589, soniaroura6@gmail.com
About this study
Official title: Phase Project (Fundació Albert Salut i Educació): Effects of a Multidisciplinary Intervention (Osteopathy and Social Work) on the Quality of Life in Children at Social Risk. A Case Series Protocol
this case series study has the aim to observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age.
Read the detailed description
To observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age.
II. Secondary objectives
- Observe if the quality of life of children in whom an osteopathic intervention is performed to the family, improves in relation to children who are not treated to the family.
- Observe if the number of sessions has any impact on the evolution of the quality of life of children.
- Observe whether age is an influential factor for improving children's quality of life.
- Observe the possible confounding factors that may influence the evolution of children's quality of life. These factors are detailed later in the section on secondary variables.
- Observe if there is a decrease in pain, in children who refer it.
- Observe if there is an improvement in the different reasons for consultation.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- Conditions
- Osteopathic Medicine, Effectiveness
- Being tested
- Osteopathic manual treatment, Social education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manual treatmentOther
Between 5 and 8 sessions of osteopathy will be carried out, and the time interval between sessions may vary depending on the need and individual evolution of each child, assessed by the team of osteopaths.
Social educationOther
- Intervention in children:
- During the school year there will be activities of two days per week with a duration of 2.5 hours per session in the afternoon.
- The activities will focus on school reinforcement, facilitating snacks and having a recreational space.
- Groups will be made by age ranges (from 4 to 6 and from 7 to 12) of maximum 10 children, due to the current COVID situation. The number could vary in the event of a change in measures at the institutional level.
- Family intervention:
- Quarterly tutoring spaces between the coordinators and the team of social educators to evaluate needs, specify objectives and assess evolution.
- Monthly group spaces for mothers managed by the team of educators where they will exchange experiences and create an informal support network.
- Monthly spaces shared between parents and children accompanied by the educational team, where family ties will be worked through play.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of self-report of health-related quality of life in pediatric patients with chronic health conditions. Is a 23-item generic health status instrument. Items are scored from 5-point Likert scale from 0 (Never) to 4 (Almost always) Scores then are transformed on a scale from 0 to 100. Step 1: Transform Score
Items are reversed scored and linearly transformed to a 0-100 scale as follows:
0=100, 1=75, 2=50, 3=25, 4=0. Mean score = Sum of the items over the number of items answered. If 50% or more items are completed: Impute the mean of the completed items in a scale.
Measured: -1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022.
Secondary outcomes (2)
Number of Osteopathy sessions
Number of osteopathy sessions needed for each child and/or family.
Measured: july 2022
Change in Numerical Pain Scale
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: At baseline and second measure at July 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Nov 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopathic MedicineStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesco Cerritelli
- Sponsor type
- University, hospital or other
- Collaborators
- Come Collaboration, Fundació Albert Salut i Educació
- Responsible party
- Sponsor-investigator, Francesco Cerritelli, Come Collaboration
- Investigators
- Sonia Roura Carvajal, MsC, Study director, Sonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135780
- Sponsor's protocol ID
- 26102021
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Project (Fundació Albert Salut i Educació): Effects of a Multidisciplinary Intervention (Osteopathy and Social Work) on the Quality of Life in Children at Social Risk. A Case Series Protocol
- ClinicalTrials.gov ID
- NCT05135780
- Acronym / sponsor ID
- 26102021
- Conditions
- Osteopathic Medicine, Effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Francesco CerritelliUniversity, hospital or other
- Collaborators
- Come Collaboration, Fundació Albert Salut i Educació
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 Nov 2021 (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.
this case series study has the aim to observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age.
Detailed description
To observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age.
II. Secondary objectives
- Observe if the quality of life of children in whom an osteopathic intervention is performed to the family, improves in relation to children who are not treated to the family.
- Observe if the number of sessions has any impact on the evolution of the quality of life of children.
- Observe whether age is an influential factor for improving children's quality of life.
- Observe the possible confounding factors that may influence the evolution of children's quality of life. These factors are detailed later in the section on secondary variables.
- Observe if there is a decrease in pain, in children who refer it.
- Observe if there is an improvement in the different reasons for consultation.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
- The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk.
- The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly.
- The Covid protocol that is in force during the start of the study will be taken into account.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account
Key inclusion criteria (2 listed)
- The children will be selected from the set of users of the Albert Foundation with the following criteria:
Key exclusion criteria (2 listed)
- ○ Families who do not sign consent to participate in the study.
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 |
|---|---|---|
| Osteopathic manual treatmentBetween 5 and 8 sessions of osteopathy will be carried out, and the time interval between sessions may vary depending on the need and individual evolution of each child, assessed by the team of osteopaths. | Other | – |
| Social education* Intervention in children: * During the school year there will be activities of two days per week with a duration of 2.5 hours per session in the afternoon. * The activities will focus on school reinforcement, facilitating snacks and having a recreational space. * Groups will be made by age ranges (from 4 to 6 and from 7 to 12) of maximum 10 children, due to the current COVID situation. The number could vary in the event of a change in measures at the institutional level. * Family intervention: * Quarterly tutoring spaces between the coordinators and the team of social educators to evaluate needs, specify objectives and assess evolution. * Monthly group spaces for mothers managed by the team of educators where they will exchange experiences and create an informal support network. * Monthly spaces shared between parents and children accompanied by the educational team, where family ties will be worked through play. | Other | – |
Primary outcome
Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire
Time frame: -1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022.
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of self-report of health-related quality of life in pediatric patients with chronic health conditions. Is a 23-item generic health status instrument. Items are scored from 5-point Likert scale from 0 (Never) to 4 (Almost always) Scores then are transformed on a scale from 0 to 100. Step 1: Transform Score Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Mean score = Sum of the items over the number of items answered. If 50% or more items are completed: Impute the mean of the completed items in a scale.
2 secondary outcomes
Number of Osteopathy sessions
Time frame: july 2022
Change in Numerical Pain Scale
Time frame: At baseline and second measure at July 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Sonia Roura Carvajal, MsC study director
Sonia
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 Osteopathic Medicine and Effectiveness, run by Francesco Cerritelli at 1 site in Spain.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Nov 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Roura Carvajal, Msc (+34619789589, soniaroura6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire (time frame: -1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022.). 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 26 Nov 2021.