StudentsNCT05270252
Educational Intervention for Cancer Survivorship Care.
A study testing Learning and Care in people with Students, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The study aims to determine the feasibility and acceptability of an interdisciplinary educational intervention for nursing students to acquire the competence (knowledge, skill and attitude) to care for long-term cancer survivors and their families. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Students
- What is being tested?
- Learning and Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2021to 30 Nov 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students enrolled in the 3rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study
Who cannot join
- 1st and 2nd year nursing students since they had not had contact with clinical practice.
- 4th year nursing students due to being in a clinical practice period and being outside the institution where the intervention was carried out.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Intervention in Nursing Students for the Care of Long-term Cancer Survivors and Their Families: An Exploratory Randomized Controlled Trial
The study aims to determine the feasibility and acceptability of an interdisciplinary educational intervention for nursing students to acquire the competence (knowledge, skill and attitude) to care for long-term cancer survivors and their families.
The design is an exploratory randomized controlled trial Following the framework of the Medical Research Council, the method used is a multidisciplinary educational intervention consisting of a flipped classroom, a clinical simulation and a round table with a duration of ten hours. The variables to measure effectiveness were competence and its attributes: knowledge, skills and attitude. The variable to assess acceptability and feasibility was student satisfaction. Data were collected before and after the intervention.
Read the detailed description
The study was designed following the framework of the Medical Research Council (MRC) , for complex interventions. The study participants were 3rd-year Nursing bachelor students from the University of Navarra (Spain). The educational intervention was called Learning \& Care, and it was framed within the European Higher Education Area.
For the design of the intervention, the following steps were followed within the MRC framework: (1) review of the literature to know the educational methodologies used in the field of health for the care of patients with cancer and exploration of the different conceptual models of family nursing, (2) design and development of an educational intervention proposal developed by the researchers of the study, and (3) the evaluation of the intervention proposal by a multidisciplinary Expert Panel composed of 11 members: five nurses (primary care, researchers, teachers and hospitalization), a medical oncologist, a psycho-oncologist, a pharmacist, a student, a cancer survivor and a family member of a cancer survivor. With the suggestions of the panel, the final educational intervention was developed, and the exploratory and piloting study was carried out.
The data collection lasted from February to April 2021, a period in which the students did not have exams. Sociodemographic information of all participants (intervention and control group) was collected only at baseline using a researcher-developed questionnaire that included variables such as: age, sex, previous study of some degree (it is common in Spain to do double degrees), previous courses or training related to family nursing and experience as healthcare worker (this last information was collected because some students work as nursing assistants while studying the Bachelor's degree).
In addition, data was collected on the level of knowledge, skills and attitude of the students to carry out care focused on the cancer survivor and his family, both in the Control group (CG) and in the Intervention group (IG) before and after the educational intervention with the IG. At the end of the training with the IG, the data from the IG and GC on student satisfaction were collected.
The students completed the sociodemographic information and the data on knowledge and attitude through the online platform Google Form. The principal researcher collected the data on the students' skills on a tablet. Lastly, the level of student satisfaction with the program was collected on site and on paper once the training program was completed.
- Conditions
- Students
- Being tested
- Learning and Care
- Keywords
- Long-term survivor, cancer, family, educational intervention, interdisciplinary,, educational methods
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning and CareOther
The educational intervention lasted 10 hours: six face-to-face and four for personal study. Three educational methodologies were combined.
The first: flipped classroom. Students received training material in their email: articles on the needs of families / cancer survivors and family nursing according to the Calgary Model (Wright \& Leahey, 2013) and experiential videos of survivors and family members. In the classroom, a week later, a nurse promoted students' self-learning and reflection.
The second: simulation clinical case. The students received by email a summary of the case and material for their personal work. Students in groups of three performed the entire clinical scenario.
The third: round table. The components were advanced practice nurse, medical oncologist, cancer survivor and a family member. The content revolved around personal experience in caring for family members and cancer survivors and the interdisciplinary work required for this care.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | no intervention |
| Intervention group | Experimental | Interdisciplinary educational intervention with a combination of active educational methods. Receives: Other: Learning and Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
To assess the level of knowledge acquired by students about the needs of long-term survivors and their families, as well as about family nursing and family assessment and intervention tools according to the Calgary Model, an ad hoc multiple choice test was designed. 20 multiple choice questions. The test was piloted among team members and students to validate their understanding and identify possible errors in multiple responses.
Measured: February-April (3 months)
Skills
The Van Gelderen Family-Care Rubric Scale (VGFCR) was used (Van Gelderen et al., 2019). The VGFCR is made up of 12 evaluable items, each one between 1 and 3 points. The scale groups the items into two groups: communication in the family and the family as a client. In each of the groups you can get a maximum score of 18 points. The total skill value is 36. In general, reliable VGFCR was determined with Fleiss' Kappa significance at p = 0.05 at the 95% confidence interval and Cronbach's alpha 0.842. This scale is available in English, permission was requested from the author to translate it into Spanish and I use the study. The linguistic-cultural adaptation was carried out through the direct and inverse translation methodology (Bracken \& Barona, 1991). Once the double translation was done, the scale translated into Spanish was sent to the main author, who agreed.
Measured: February-April (3 months)
Attitude
To measure attitude, the FINC-NA scale (Barreto et al., 2022) was used, which has been widely used to measure the attitude of nurses to involve families in care. The scale consists of 26 evaluable items in a range between 1 and 4 points, organized into 4 groups: (1) Family as another resource for nursing care, (2) Family as collaborator in dialogue, (3) Family as burden and ( 4) Family as their own resource. For the calculation of the "family as a burden" group, the data were inverted (Hagedoorn et al., 2020). The total value of the attitude scale is 104 points. This scale is validated in Spanish in a sample of 274 professionals and obtained a total Cronbach's alpha coefficient of 0.864 for the total scale, ranging between 0.888 and 0.769 in the subscales. The factorial analysis identified 4 factors that explained 54.22% of the total variance (Pascual Fernandez et al., 2015).
Measured: February-April (3 months)
Secondary outcomes (1)
student satisfaction
For the evaluation of the secondary variable, student satisfaction with the Learning \& Care intervention, the Client Satisfaction Questionnaire (CSQ-8) (Echeburua \& Corral, 2010) was used. This questionnaire consists of 8 items and has been validated in Spanish with very high levels of internal consistency, according to Cronbach's coefficients, which range between 0.83 and 0.93.(Echeburua \& Corral, 2010; Martinez-Azurmenti \& Beitia Fernandez, 2014).
Measured: February-April (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start9 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StudentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed following the framework of the Medical Research Council (MRC) (Craig et al., 2019), for complex interventions. The sample size was estimated in at least 58 participants assuming a percentage of potential losses of 10%. The recruitment period was from January-February 2021. After receiving permission of the University and approvals from the Ethics Committee (REF. 2020.161), the principal researcher presented the project to the students with a brief oral presentation supported by video. The students who agreed to participate scanned a QR code through which they could request information indicating a contact email. Students who requested information, and who met the inclusion criteria, were sent a project information sheet, as well as a Doodle to sign up for the first session. Before the first session, they signed the informed consent and the sociodemographic data were collected through a Google Form questionnaire.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Domingo, Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270252
- Sponsor's protocol ID
- EICS
- Status last verified
- Dec 2021
- First submitted
- 22 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Wright LM. Brain science and illness beliefs: an unexpected explanation of the healing power of therapeutic conversations and the family interventions that matter. J Fam Nurs. 2015 May;21(2):186-205. doi: 10.1177/1074840715575822. Epub 2015 Mar 12.
PubMed 25766206Gelderen, S. Van, Engebretson, A., Miller, A., Hancock, A., Ehmke, S., Swan, M., & Garrow, A. (2019). A Family-Care Rubric : Developing Family Care and Communication Skills Using Simulation. Clinical Simulation in Nursing, 36, 47-58. https://doi.org/10.1016/j.ecns.2019.07.006
Bracken, B. A., & Barona, A. (1991). State of the Art Procedures for Translating, Validating and Using Psychoeducational Tests in Cross-Cultural Assessment. School Psychology International, 12(April 1991), 119-132. https://doi.org/10.1177/0143034391121010
Barreto MDS, Marquete VF, Camparoto CW, Garcia-Vivar C, Barbieri-Figueiredo MDC, Marcon SS. Factors associated with nurses' positive attitudes towards families' involvement in nursing care: A scoping review. J Clin Nurs. 2022 Dec;31(23-24):3338-3349. doi: 10.1111/jocn.16226. Epub 2022 Jan 26.
PubMed 35083808Hagedoorn EI, Paans W, Jaarsma T, Keers JC, van der Schans CP, Luttik MLA. The importance of families in nursing care: attitudes of nurses in the Netherlands. Scand J Caring Sci. 2021 Dec;35(4):1207-1215. doi: 10.1111/scs.12939. Epub 2020 Dec 3.
PubMed 33270268Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Domingo-Osle M, La Rosa-Salas V, Ambrosio L, Elizondo-Rodriguez N, Garcia-Vivar C. Educational methods used in cancer training for health sciences students: An integrative review. Nurse Educ Today. 2021 Feb;97:104704. doi: 10.1016/j.nedt.2020.104704. Epub 2020 Dec 7.
PubMed 33352353Domingo-Osle M, La Rosa-Salas V, Garcia-Vivar C. Educational Intervention for Family Nursing Students in Long-Term Cancer Survivorship: A Randomized Pilot Trial. J Fam Nurs. 2023 Aug;29(3):248-262. doi: 10.1177/10748407231167438. Epub 2023 May 21.
PubMed 37211798
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention in Nursing Students for the Care of Long-term Cancer Survivors and Their Families: An Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05270252
- Acronym / sponsor ID
- EICS
- Conditions
- Students
- Keywords
- Long-term survivor, cancer, family, educational intervention, interdisciplinary,, educational methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Mar 2022 (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 study aims to determine the feasibility and acceptability of an interdisciplinary educational intervention for nursing students to acquire the competence (knowledge, skill and attitude) to care for long-term cancer survivors and their families.
The design is an exploratory randomized controlled trial Following the framework of the Medical Research Council, the method used is a multidisciplinary educational intervention consisting of a flipped classroom, a clinical simulation and a round table with a duration of ten hours. The variables to measure effectiveness were competence and its attributes: knowledge, skills and attitude. The variable to assess acceptability and feasibility was student satisfaction. Data were collected before and after the intervention.
Detailed description
The study was designed following the framework of the Medical Research Council (MRC) , for complex interventions. The study participants were 3rd-year Nursing bachelor students from the University of Navarra (Spain). The educational intervention was called Learning \& Care, and it was framed within the European Higher Education Area.
For the design of the intervention, the following steps were followed within the MRC framework: (1) review of the literature to know the educational methodologies used in the field of health for the care of patients with cancer and exploration of the different conceptual models of family nursing, (2) design and development of an educational intervention proposal developed by the researchers of the study, and (3) the evaluation of the intervention proposal by a multidisciplinary Expert Panel composed of 11 members: five nurses (primary care, researchers, teachers and hospitalization), a medical oncologist, a psycho-oncologist, a pharmacist, a student, a cancer survivor and a family member of a cancer survivor. With the suggestions of the panel, the final educational intervention was developed, and the exploratory and piloting study was carried out.
The data collection lasted from February to April 2021, a period in which the students did not have exams. Sociodemographic information of all participants (intervention and control group) was collected only at baseline using a researcher-developed questionnaire that included variables such as: age, sex, previous study of some degree (it is common in Spain to do double degrees), previous courses or training related to family nursing and experience as healthcare worker (this last information was collected because some students work as nursing assistants while studying the Bachelor's degree).
In addition, data was collected on the level of knowledge, skills and attitude of the students to carry out care focused on the cancer survivor and his family, both in the Control group (CG) and in the Intervention group (IG) before and after the educational intervention with the IG. At the end of the training with the IG, the data from the IG and GC on student satisfaction were collected.
The students completed the sociodemographic information and the data on knowledge and attitude through the online platform Google Form. The principal researcher collected the data on the students' skills on a tablet. Lastly, the level of student satisfaction with the program was collected on site and on paper once the training program was completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was designed following the framework of the Medical Research Council (MRC) (Craig et al., 2019), for complex interventions. The sample size was estimated in at least 58 participants assuming a percentage of potential losses of 10%. The recruitment period was from January-February 2021. After receiving permission of the University and approvals from the Ethics Committee (REF. 2020.161), the principal researcher presented the project to the students with a brief oral presentation supported by video. The students who agreed to participate scanned a QR code through which they could request information indicating a contact email. Students who requested information, and who met the inclusion criteria, were sent a project information sheet, as well as a Doodle to sign up for the first session. Before the first session, they signed the informed consent and the sociodemographic data were collected through a Google Form questionnaire.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –no intervention |
| Intervention group | Experimental | Other: Learning and CareInterdisciplinary educational intervention with a combination of active educational methods. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students enrolled in the 3rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study
Key exclusion criteria (2 listed)
- 1st and 2nd year nursing students since they had not had contact with clinical practice.
- 4th year nursing students due to being in a clinical practice period and being outside the institution where the intervention was carried out.
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 |
|---|---|---|
| Learning and CareThe educational intervention lasted 10 hours: six face-to-face and four for personal study. Three educational methodologies were combined. The first: flipped classroom. Students received training material in their email: articles on the needs of families / cancer survivors and family nursing according to the Calgary Model (Wright \& Leahey, 2013) and experiential videos of survivors and family members. In the classroom, a week later, a nurse promoted students' self-learning and reflection. The second: simulation clinical case. The students received by email a summary of the case and material for their personal work. Students in groups of three performed the entire clinical scenario. The third: round table. The components were advanced practice nurse, medical oncologist, cancer survivor and a family member. The content revolved around personal experience in caring for family members and cancer survivors and the interdisciplinary work required for this care. | Other | Intervention group |
Primary outcome
Knowledge
Time frame: February-April (3 months)
To assess the level of knowledge acquired by students about the needs of long-term survivors and their families, as well as about family nursing and family assessment and intervention tools according to the Calgary Model, an ad hoc multiple choice test was designed. 20 multiple choice questions. The test was piloted among team members and students to validate their understanding and identify possible errors in multiple responses.
Skills
Time frame: February-April (3 months)
The Van Gelderen Family-Care Rubric Scale (VGFCR) was used (Van Gelderen et al., 2019). The VGFCR is made up of 12 evaluable items, each one between 1 and 3 points. The scale groups the items into two groups: communication in the family and the family as a client. In each of the groups you can get a maximum score of 18 points. The total skill value is 36. In general, reliable VGFCR was determined with Fleiss' Kappa significance at p = 0.05 at the 95% confidence interval and Cronbach's alpha 0.842. This scale is available in English, permission was requested from the author to translate it into Spanish and I use the study. The linguistic-cultural adaptation was carried out through the direct and inverse translation methodology (Bracken \& Barona, 1991). Once the double translation was done, the scale translated into Spanish was sent to the main author, who agreed.
Attitude
Time frame: February-April (3 months)
To measure attitude, the FINC-NA scale (Barreto et al., 2022) was used, which has been widely used to measure the attitude of nurses to involve families in care. The scale consists of 26 evaluable items in a range between 1 and 4 points, organized into 4 groups: (1) Family as another resource for nursing care, (2) Family as collaborator in dialogue, (3) Family as burden and ( 4) Family as their own resource. For the calculation of the "family as a burden" group, the data were inverted (Hagedoorn et al., 2020). The total value of the attitude scale is 104 points. This scale is validated in Spanish in a sample of 274 professionals and obtained a total Cronbach's alpha coefficient of 0.864 for the total scale, ranging between 0.888 and 0.769 in the subscales. The factorial analysis identified 4 factors that explained 54.22% of the total variance (Pascual Fernandez et al., 2015).
1 secondary outcome
student satisfaction
Time frame: February-April (3 months)
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 8 Mar 2022.
- Background: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Background: PubMed 25766206Wright LM. Brain science and illness beliefs: an unexpected explanation of the healing power of therapeutic conversations and the family interventions that matter. J Fam Nurs. 2015 May;21(2):186-205. doi: 10.1177/1074840715575822. Epub 2015 Mar 12.
- BackgroundGelderen, S. Van, Engebretson, A., Miller, A., Hancock, A., Ehmke, S., Swan, M., & Garrow, A. (2019). A Family-Care Rubric : Developing Family Care and Communication Skills Using Simulation. Clinical Simulation in Nursing, 36, 47-58. https://doi.org/10.1016/j.ecns.2019.07.006
- BackgroundBracken, B. A., & Barona, A. (1991). State of the Art Procedures for Translating, Validating and Using Psychoeducational Tests in Cross-Cultural Assessment. School Psychology International, 12(April 1991), 119-132. https://doi.org/10.1177/0143034391121010
- Background: PubMed 35083808Barreto MDS, Marquete VF, Camparoto CW, Garcia-Vivar C, Barbieri-Figueiredo MDC, Marcon SS. Factors associated with nurses' positive attitudes towards families' involvement in nursing care: A scoping review. J Clin Nurs. 2022 Dec;31(23-24):3338-3349. doi: 10.1111/jocn.16226. Epub 2022 Jan 26.
- Background: PubMed 33270268Hagedoorn EI, Paans W, Jaarsma T, Keers JC, van der Schans CP, Luttik MLA. The importance of families in nursing care: attitudes of nurses in the Netherlands. Scand J Caring Sci. 2021 Dec;35(4):1207-1215. doi: 10.1111/scs.12939. Epub 2020 Dec 3.
- Results publication: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- Results publication: PubMed 33352353Domingo-Osle M, La Rosa-Salas V, Ambrosio L, Elizondo-Rodriguez N, Garcia-Vivar C. Educational methods used in cancer training for health sciences students: An integrative review. Nurse Educ Today. 2021 Feb;97:104704. doi: 10.1016/j.nedt.2020.104704. Epub 2020 Dec 7.
- Derived from this study: PubMed 37211798Domingo-Osle M, La Rosa-Salas V, Garcia-Vivar C. Educational Intervention for Family Nursing Students in Long-Term Cancer Survivorship: A Randomized Pilot Trial. J Fam Nurs. 2023 Aug;29(3):248-262. doi: 10.1177/10748407231167438. Epub 2023 May 21.
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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.
Marta Domingo principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning and Care in people with Students, run by Clinica Universidad de Navarra, Universidad de Navarra 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 1 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: finished, as of the sponsor's last update on 8 Mar 2022. 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?
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?
Knowledge (time frame: February-April (3 months)). 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?
On the ClinicalTrials.gov record for NCT05270252, which also lists 9 linked publications.
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 Mar 2022.