Substance UseNCT04592120
Randomized Trial of a Data-driven Technical Assistance System for Drug Prevention Coalitions
A study testing Coalition Check-Up in people with Substance Use and Adolescent Problem Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This project is designed to test the Coalition Check-Up (CCU)-a theory-based and data-driven technical assistance (TA) system that supports community coalitions' implementation of evidence-based programs (EBPs) for drug prevention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Use, Adolescent Problem Behavior
- What is being tested?
- Coalition Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 15 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible coalitions must be fully operational, thus: 1) have been in existence for at least one year; 2) have a designated coordinator; 3) have at least quarterly meetings in which multiple sectors of the community attend; 4) currently support implementation of drug prevention activities or secured funding to do so; 5) be willing to complete coalition capacity and EBP implementation assessments annually; 7) be willing to participate in four in-person meetings annually with the CCU TA provider.
Who cannot join
- Exist outside of Pennsylvania or Missouri
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Research Center
University Park, Pennsylvania, 16802
About this study
This project is designed to test the Coalition Check-Up (CCU)-a theory-based and data-driven technical assistance (TA) system that supports community coalitions' implementation of evidence-based programs (EBPs) for drug prevention. The primary aims of the project are to: 1) Estimate the impact of the CCU on coalition capacity. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition to evaluate whether the CCU improves coalition capacity as measured by coalition member reports of team processes, network composition, and collaborative structure. 2) Estimate the impact of the CCU on implementation of evidence-based programs. The study will test the hypothesis that coalitions receiving the CCU will implement EBPs with greater: a) quantity, b) quality, and c) sustainability. The study will also test coalition capacity as a mediator of CCU impact on EBP implementation. 3) Estimate the impact of the CCU on youth substance use. The study will test the hypothesis that communities receiving the CCU will reduce youth substance use relative to communities in the comparison condition. The study will also test EBP implementation as a mediator of CCU impact on youth substance use.
Read the detailed description
The overall goal of this five-year R01 study is to test the Coalition Check-Up (CCU) technical assistance (TA) system for supporting community coalitions' implementation of evidence-based drug prevention programs (EBPs). Over 5,000 community anti-drug coalitions operating in the U.S serve as a cornerstone of federal drug prevention. These coalitions, however, have only demonstrated efficacy in preventing substance use when they use TA and implement EBPs, a key research-to-practice gap. The CCU supports coalitions by identifying and addressing gaps in EBP implementation capacity. The proposed study advances implementation science by applying Wandersman's Interactive Systems Framework to test the effects of CCU on coalition EBP implementation capacity and youth outcomes. Despite the popularity of community anti-drug coalitions as a mechanism for EBP dissemination, scant research addresses how to support coalitions for optimal EBP implementation. Lacking adequate support, coalitions and EBPs often fail. Intensive TA provided in evidence-based coalition models is effective but often too expensive to scale in real-world settings. The CCU provides a lower-cost TA system that is broadly applicable across coalition models. The study's main objective is to test the overall effectiveness of the CCU, including how it contributes to EBP implementation and prevention of youth substance use. Building on the Interactive System Framework, the central hypothesis is that the CCU can enhance the prevention support system, thereby increasing coalition capacity for EBP implementation and the probability that EBPs will reduce youth substance use. The study will test this central hypothesis by pursuing three specific aims. The first aim is to estimate the impact of the CCU on coalition capacity, including team processes, network composition, and collaborative structure. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition. The second aim is to estimate the impact of the CCU on implementation of EBPs, including EBP reach, implementation quality, and sustainability. The third aim is to estimate the impact of the CCU on youth substance use, including alcohol, tobacco, marijuana, and opioids. The CCU is innovative in its emphasis on proactive monitoring and data-driven TA, its use of motivational interviewing to enhance coalition-driven action planning, and its examination of network structure to enhance coalition capacity. The proposed study's contribution is highly significant because the field currently lacks clear evidence of the effectiveness of a TA model applicable to the heterogeneous mix of drug prevention coalitions in operation. The research will enhance community coalition ability to bridge the research to practice gap in drug prevention programming. Results are expected to have a positive impact on the field by establishing the evidence-base for a low-cost, data-driven, manualized TA model that identifies how to intervene with community coalitions to support sustained implementation of evidence-based drug prevention programs and policies known to promote community health.
- Conditions
- Substance Use, Adolescent Problem Behavior
- Being tested
- Coalition Check-Up
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coalition Check-UpBehavioural
The Coalition Check-Up identifies and addresses coalition and implementation capacity deficiencies that frequently lead to failure, following recommendations from the audit and feedback literature.
| Study group | Role | What they receive |
|---|---|---|
| Coalition Check-Up | Experimental | The 4-step Coalition Check-Up technical assistance process provides proactive data-driven continuous quality improvement cycles. Step 1 assesses critical dimensions of the coalition's capacity and program implementation. A coalition profile based on assessment data is reviewed in step 2. Here the technical assistance provider works with the coalition to consider several dimensions of coalition capacity and program implementation, celebrating strengths and prioritizing weaknesses. Once priorities are set, the technical assistance provider uses structured action planning in step 3 to help coalition members establish consensus on how to improve prioritized weaknesses. In step 4, technical assistance providers review and support progress on action plan implementation with the coalition. Efforts are evaluated a year after the initial assessment in a continuous quality improvement cycle. Receives: Behavioral: Coalition Check-Up |
| Technical assistance as usual | No intervention | Coalitions in the comparison condition will receive a feedback report but no additional support from technical assistance providers beyond what is already available to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohesion
the extent to which coalition members perceived feelings of unity, group spirit, trust, and belonging within their coalition. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
Measured: 3 years
Efficiency
the work ethic, efficiency, and task focus of the coalition members. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
Measured: 3 years
Decentralization
a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization).
Measured: 3 years
Multiplexity
the number of unique types of cooperation or interaction each partner reported for a relationship with another partner (e.g., sharing information, personnel, monetary resources, or other cooperation). Ranges from 0 (no multiplexity) to 4 (high multiplexity).
Measured: 3 years
Intersectoral communication
respondents name individuals in the coalition to whom they went to for advice about coalition matters. When an individual cited a person from a different sector as someone to whom they went for advice, that dyad is counted as an intersectoral tie. The level of intersectoral communication for each coalition is measured as the coalition's mean number of intersectoral ties per respondent, which ranges from 0 (no intersectoral ties) to 5 (all intersectoral ties).
Measured: 3 years
Evidenced-based program quantity
computed as the number of youth reached annually by all coalition-supported evidence-based programs
Measured: 3 years
Evidence-based program implementation quality
a composite of 7 scales: a) Staff training (6 items); b) Staff motivation and competence (5 items); c) Fidelity monitoring (11 items); d) Evaluation (13 items); e) Dosage (2 items); f) Adherence (7 items); and g) Implementation barriers (11 items). Scores range from 0 (low implementation quality) to 6 (high implementation quality).
Measured: 3 years
Overall Evidence-based program sustainability
the sum number of years all EBPs are in operation during years 2-4 of the project, including both existing and new EBPs. An EBP will be designated as non-operational when: a) it has no reach; or b) an absence of ongoing training or TA in the past 12 months and no funding available to support the program
Measured: 3 years
Sustainability planning
the mean of 12 items about the completion of sustainability planning activities. Ranges from 0 = no sustainability planning to 4 = extensive sustainability planning.
Measured: 3 years
Dichotomized lifetime alcohol use
Past use of alcohol ever (yes = 1 / no = 0)
Measured: 3 years
Dichotomized lifetime tobacco use
Past use of tobacco ever (yes = 1 / no = 0)
Measured: 3 years
Dichotomized lifetime marijuana use
Past use of marijuana ever (yes = 1 / no = 0)
Measured: 3 years
Dichotomized lifetime opioid use
Past use of prescription pain relievers without a doctor's orders or heroin ever (yes = 1 / no = 0)
Measured: 3 years
Past 30-day alcohol use
Past 30-day use of alcohol (yes = 1 / no = 0)
Measured: 3 years
Past 30-day tobacco use
Past 30-day use of tobacco (yes = 1 / no = 0)
Measured: 3 years
Past 30-day marijuana use
Past 30-day use of marijuana (yes = 1 / no = 0)
Measured: 3 years
Past 30-day opioid use
Past 30-day use of prescription pain relievers without a doctor's orders or heroin (yes = 1 / no = 0)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Oct 2020
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At baseline, community coalitions will be randomly assigned to either the Coalition Check-Up experimental condition or the technical assistance as usual comparison condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Penn State University
- Responsible party
- Principal investigator, Louis D. Brown, The University of Texas Health Science Center, Houston
- Investigators
- Louis D Brown, PhD, Principal investigator, The University of Texas Health Science Center, HoustonSarah M Chilenski, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592120
- Sponsor's protocol ID
- HSC-SPH-19-0033
- Other IDs
- R01DA045815
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2020
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, we will share de-identified data from published studies with interested investigators once they have obtained IRB approval. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of communities and schools with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any participants; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
Publications
Brown LD, Chilenski SM, Wells R, Jones EC, Welsh JA, Gayles JG, Fernandez ME, Jones DE, Mallett KA, Feinberg ME. Protocol for a hybrid type 3 cluster randomized trial of a technical assistance system supporting coalitions and evidence-based drug prevention programs. Implement Sci. 2021 Jun 25;16(1):64. doi: 10.1186/s13012-021-01133-z.
PubMed 34172065
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Data-driven Technical Assistance System for Drug Prevention Coalitions
- ClinicalTrials.gov ID
- NCT04592120
- Acronym / sponsor ID
- HSC-SPH-19-0033
- Conditions
- Substance Use, Adolescent Problem Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Penn State University
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is designed to test the Coalition Check-Up (CCU)-a theory-based and data-driven technical assistance (TA) system that supports community coalitions' implementation of evidence-based programs (EBPs) for drug prevention. The primary aims of the project are to: 1) Estimate the impact of the CCU on coalition capacity. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition to evaluate whether the CCU improves coalition capacity as measured by coalition member reports of team processes, network composition, and collaborative structure. 2) Estimate the impact of the CCU on implementation of evidence-based programs. The study will test the hypothesis that coalitions receiving the CCU will implement EBPs with greater: a) quantity, b) quality, and c) sustainability. The study will also test coalition capacity as a mediator of CCU impact on EBP implementation. 3) Estimate the impact of the CCU on youth substance use. The study will test the hypothesis that communities receiving the CCU will reduce youth substance use relative to communities in the comparison condition. The study will also test EBP implementation as a mediator of CCU impact on youth substance use.
Detailed description
The overall goal of this five-year R01 study is to test the Coalition Check-Up (CCU) technical assistance (TA) system for supporting community coalitions' implementation of evidence-based drug prevention programs (EBPs). Over 5,000 community anti-drug coalitions operating in the U.S serve as a cornerstone of federal drug prevention. These coalitions, however, have only demonstrated efficacy in preventing substance use when they use TA and implement EBPs, a key research-to-practice gap. The CCU supports coalitions by identifying and addressing gaps in EBP implementation capacity. The proposed study advances implementation science by applying Wandersman's Interactive Systems Framework to test the effects of CCU on coalition EBP implementation capacity and youth outcomes. Despite the popularity of community anti-drug coalitions as a mechanism for EBP dissemination, scant research addresses how to support coalitions for optimal EBP implementation. Lacking adequate support, coalitions and EBPs often fail. Intensive TA provided in evidence-based coalition models is effective but often too expensive to scale in real-world settings. The CCU provides a lower-cost TA system that is broadly applicable across coalition models. The study's main objective is to test the overall effectiveness of the CCU, including how it contributes to EBP implementation and prevention of youth substance use. Building on the Interactive System Framework, the central hypothesis is that the CCU can enhance the prevention support system, thereby increasing coalition capacity for EBP implementation and the probability that EBPs will reduce youth substance use. The study will test this central hypothesis by pursuing three specific aims. The first aim is to estimate the impact of the CCU on coalition capacity, including team processes, network composition, and collaborative structure. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition. The second aim is to estimate the impact of the CCU on implementation of EBPs, including EBP reach, implementation quality, and sustainability. The third aim is to estimate the impact of the CCU on youth substance use, including alcohol, tobacco, marijuana, and opioids. The CCU is innovative in its emphasis on proactive monitoring and data-driven TA, its use of motivational interviewing to enhance coalition-driven action planning, and its examination of network structure to enhance coalition capacity. The proposed study's contribution is highly significant because the field currently lacks clear evidence of the effectiveness of a TA model applicable to the heterogeneous mix of drug prevention coalitions in operation. The research will enhance community coalition ability to bridge the research to practice gap in drug prevention programming. Results are expected to have a positive impact on the field by establishing the evidence-base for a low-cost, data-driven, manualized TA model that identifies how to intervene with community coalitions to support sustained implementation of evidence-based drug prevention programs and policies known to promote community health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- At baseline, community coalitions will be randomly assigned to either the Coalition Check-Up experimental condition or the technical assistance as usual comparison condition.
| Arm | Type | Receives |
|---|---|---|
| Coalition Check-Up | Experimental | Behavioral: Coalition Check-UpThe 4-step Coalition Check-Up technical assistance process provides proactive data-driven continuous quality improvement cycles. Step 1 assesses critical dimensions of the coalition's capacity and program implementation. A coalition profile based on assessment data is reviewed in step 2. Here the technical assistance provider works with the coalition to consider several dimensions of coalition capacity and program implementation, celebrating strengths and prioritizing weaknesses. Once priorities are set, the technical assistance provider uses structured action planning in step 3 to help coalition members establish consensus on how to improve prioritized weaknesses. In step 4, technical assistance providers review and support progress on action plan implementation with the coalition. Efforts are evaluated a year after the initial assessment in a continuous quality improvement cycle. |
| Technical assistance as usual | No intervention | –Coalitions in the comparison condition will receive a feedback report but no additional support from technical assistance providers beyond what is already available to them. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible coalitions must be fully operational, thus: 1) have been in existence for at least one year; 2) have a designated coordinator; 3) have at least quarterly meetings in which multiple sectors of the community attend; 4) currently support implementation of drug prevention activities or secured funding to do so; 5) be willing to complete coalition capacity and EBP implementation assessments annually; 7) be willing to participate in four in-person meetings annually with the CCU TA provider.
Key exclusion criteria (1 listed)
- Exist outside of Pennsylvania or Missouri
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 |
|---|---|---|
| Coalition Check-UpThe Coalition Check-Up identifies and addresses coalition and implementation capacity deficiencies that frequently lead to failure, following recommendations from the audit and feedback literature. | Behavioural | Coalition Check-Up |
Primary outcome
Cohesion
Time frame: 3 years
the extent to which coalition members perceived feelings of unity, group spirit, trust, and belonging within their coalition. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
Efficiency
Time frame: 3 years
the work ethic, efficiency, and task focus of the coalition members. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
Decentralization
Time frame: 3 years
a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization).
Multiplexity
Time frame: 3 years
the number of unique types of cooperation or interaction each partner reported for a relationship with another partner (e.g., sharing information, personnel, monetary resources, or other cooperation). Ranges from 0 (no multiplexity) to 4 (high multiplexity).
Intersectoral communication
Time frame: 3 years
respondents name individuals in the coalition to whom they went to for advice about coalition matters. When an individual cited a person from a different sector as someone to whom they went for advice, that dyad is counted as an intersectoral tie. The level of intersectoral communication for each coalition is measured as the coalition's mean number of intersectoral ties per respondent, which ranges from 0 (no intersectoral ties) to 5 (all intersectoral ties).
Evidenced-based program quantity
Time frame: 3 years
computed as the number of youth reached annually by all coalition-supported evidence-based programs
Evidence-based program implementation quality
Time frame: 3 years
a composite of 7 scales: a) Staff training (6 items); b) Staff motivation and competence (5 items); c) Fidelity monitoring (11 items); d) Evaluation (13 items); e) Dosage (2 items); f) Adherence (7 items); and g) Implementation barriers (11 items). Scores range from 0 (low implementation quality) to 6 (high implementation quality).
Overall Evidence-based program sustainability
Time frame: 3 years
the sum number of years all EBPs are in operation during years 2-4 of the project, including both existing and new EBPs. An EBP will be designated as non-operational when: a) it has no reach; or b) an absence of ongoing training or TA in the past 12 months and no funding available to support the program
Sustainability planning
Time frame: 3 years
the mean of 12 items about the completion of sustainability planning activities. Ranges from 0 = no sustainability planning to 4 = extensive sustainability planning.
Dichotomized lifetime alcohol use
Time frame: 3 years
Past use of alcohol ever (yes = 1 / no = 0)
Dichotomized lifetime tobacco use
Time frame: 3 years
Past use of tobacco ever (yes = 1 / no = 0)
Dichotomized lifetime marijuana use
Time frame: 3 years
Past use of marijuana ever (yes = 1 / no = 0)
Dichotomized lifetime opioid use
Time frame: 3 years
Past use of prescription pain relievers without a doctor's orders or heroin ever (yes = 1 / no = 0)
Past 30-day alcohol use
Time frame: 3 years
Past 30-day use of alcohol (yes = 1 / no = 0)
Past 30-day tobacco use
Time frame: 3 years
Past 30-day use of tobacco (yes = 1 / no = 0)
Past 30-day marijuana use
Time frame: 3 years
Past 30-day use of marijuana (yes = 1 / no = 0)
Past 30-day opioid use
Time frame: 3 years
Past 30-day use of prescription pain relievers without a doctor's orders or heroin (yes = 1 / no = 0)
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 11 Dec 2024.
- Derived from this study: PubMed 34172065Brown LD, Chilenski SM, Wells R, Jones EC, Welsh JA, Gayles JG, Fernandez ME, Jones DE, Mallett KA, Feinberg ME. Protocol for a hybrid type 3 cluster randomized trial of a technical assistance system supporting coalitions and evidence-based drug prevention programs. Implement Sci. 2021 Jun 25;16(1):64. doi: 10.1186/s13012-021-01133-z.
- Individual participant dataSharing planned: Yes. Upon request, we will share de-identified data from published studies with interested investigators once they have obtained IRB approval. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of communities and schools with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any participants; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
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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.
Louis D Brown, PhD principal investigator
The University of Texas Health Science Center, Houston
Sarah M Chilenski, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coalition Check-Up in people with Substance Use and Adolescent Problem Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 1 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 11 Dec 2024. 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 United States. 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?
Cohesion (time frame: 3 years). The study lists 17 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 NCT04592120, which also lists 1 linked publication.
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 11 Dec 2024.