Health Knowledge, Attitudes, PracticeAcTiNCT04799860
Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting (AcTi)
A study testing health promotive work-way in people with Health Knowledge, Attitudes, Practice, run by Region Örebro County at 1 site in Sweden.
Trial summary
The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- health promotive work-way
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteSweden
- Study dates
- 30 Mar 2021to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being a caregiver meeting patients and/or
- being assigned a role as internal or external facilitator in the project
- Inclusion criteria for patients filling in the study specific questionnaire:
- 18 years or older
- visiting primary care units a specific time pre- or post implementation support
- : having one or more unhealthy life-style habit 18 years or older
- being a manager at a primary care unit or at higher level
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Act in Time- Implementation of Health Promotive Work-way in Primary Care Setting - Evaluation of Effect- and Implementation Process (AcTi)
The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves.
Read the detailed description
Insufficient physical activity, hazardous use of alcohol, tobacco use and unhealthy eating habits increase the risk of cardiovascular diseases, cancer and type 2-diabetes. Health-promoting work reduces the disease risk and mortality and should thus be integrated in clinical care processes.
Despite support by the National guideline for prevention and treatment of unhealthy life-style habits, there is a chasm to bridge when integrating evidence into clinical practise. Prerequisites for changing work-ways are often underestimated and left to the individual co-workers to full fill on their own.
Too few patients are asked about life-style habits and too few receive evidence-based measures. The measures taken may also depend on sex, language, residence and caregiver's profession. The investigators strive to support the implementation of a health-promoting way of working that includes self-reporting of life-style habits before a visit and that takes measures for those with at least one unhealthy lifestyle habit.
The aim is to identify effective implementation strategies for health-promoting efforts in the primary care. The perceptions of barriers and opportunities when changing way of working from the target groups (leaders, co-workers, patients) will be used to enhance the possibility of successful implementation. Strategies are enhanced by theories of leading change. External and internal facilitators support the implementation.
The study will evaluate the effects and the implementation process at the level of leaders, patients, co-workers, facilitators and organisation in short (4-6 months) and long term (16-18 months).
The project provides generalizable knowledge on strategies to overcome the gap between evidence and praxis, contributing to utilize an existing synthesized knowledgebase regarding health-promoting and preventative workways in a Swedish primary care setting.
It is central for the health care system to identify successful implementation strategies in order to manage their future mission.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- health promotive work-way
- Keywords
- implementation, primary care, process evaluation
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health promotive work-wayBehavioural
Clinical intervention: The patient is asked to fill in a screening form with life-style related questions. The caregiver takes adequate measures according to the recommendations of the national guideline and the filled in screeing form. The caregiver documents the measures taken.
Implementation intervention as described previously: using tailored strategies to support implementation of the gudieline-based recommendations
| Study group | Role | What they receive |
|---|---|---|
| health promotive work-way | Experimental | Six primary care units that voluntarily enrolls as experimental units. The units will receive implementation support based on previous research and tailored to the specific prerequisits and context for each unit. Strategies includes involvement of target groups; informationa and interactive education;use of external and internal facilitators tarined for the purpose; systematic feedback and learning dialogs during the project. The implementation support will take approximately 12 months. Receives: Behavioral: health promotive work-way |
| Control | No intervention | Six primary care centers of similar size and socioeconomic background in the population listed to each center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change and trend from baseline documented codes in medical records
specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity
Measured: Change from baseline (6 months), through study completion up to 6 months after end of implementation support
Change and trend from baseline documented codes in medical records
specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity
Measured: Change from baseline (6 months), through study completion up to 18 months after end of implementation support
Change in S-NoMAD score (Swedish translation of NoMAD
23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring
Measured: Change from baseline S-Nomad score up to 4 to 6 months after end of study completion
Change in S-NoMAD score (Swedish translation of NoMAD
23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring
Measured: Change from baseline S-Nomad score up to 16 to 18 months after end of study completion
Secondary outcomes (3)
Change in perceived clincial intervention by a study specific questionnaire
Questions related to the patients' perception on receiving the clinical intervention or not
Measured: Change from baseline up to 4 to 6 months after end of implementation support
Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.
Appropriateness, feasability, acceptability of the clinical intervention is rated on a 5-graded scale with 4 items per construct
Measured: Change from baseline in AIM,IAM and FIM up to 4 to 6 months after end of implementation support
Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.
Appropriateness, feasability, acceptability of the clinical intervention is rated on a 5-graded scale with 4 items per construct
Measured: Change from baseline in AIM,IAM and FIM up to 16 to18 months after end of implementation support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start30 Mar 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pre-post-intervention design with control group will be used to evaluate intervention uptake and implementation process effectiveness from the perspective of managers, primary care professionals, patients, and organisation. Primary care settings in central Sweden will be supported in implementing a guideline-based health-promoting way of working including screening of life-style habits, measures taken according to evidence based recommendations and documentation. Strategies will include interactive education sessions, external and internal facilitators, audit and feedback, and tools from theories of leading change; tailored according to contextual and participant needs.
- Masking
- None (open label)
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ylva Nilsagård, Study director, University Health Care Research Center, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799860
- Sponsor's protocol ID
- 275301
- Acronym
- AcTi
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2021
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't collect individual data other than in the qualitative parts and we don't have ethical approval to share that
Publications
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
PubMed 25791983Wandell PE, de Waard AM, Holzmann MJ, Gornitzki C, Lionis C, de Wit N, Sondergaard J, Sonderlund AL, Kral N, Seifert B, Korevaar JC, Schellevis FG, Carlsson AC. Barriers and facilitators among health professionals in primary care to prevention of cardiometabolic diseases: A systematic review. Fam Pract. 2018 Jul 23;35(4):383-398. doi: 10.1093/fampra/cmx137.
PubMed 29385438Nilsen P, Schildmeijer K, Ericsson C, Seing I, Birken S. Implementation of change in health care in Sweden: a qualitative study of professionals' change responses. Implement Sci. 2019 May 14;14(1):51. doi: 10.1186/s13012-019-0902-6.
PubMed 31088483Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Aberg AC. The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing. Implement Sci. 2018 Dec 4;13(1):146. doi: 10.1186/s13012-018-0835-5.
PubMed 30509289Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PubMed 10474547Nilsagard Y, Nilsing-Strid E. Sustainability of implementation of health-promotion practice in primary healthcare: a non-randomized parallel group study. BMC Health Serv Res. 2026 Jul 20;26(1):1006. doi: 10.1186/s12913-026-15103-y.
PubMed 42477730Karin B, Ylva N, Maria HN, Lars W, Emma NS. Act in time: primary health care professionals', internal facilitators', and managers' experiences of working health-promotively after a 12-month implementation intervention: a qualitative study using normalization process theory. BMC Prim Care. 2026 Jan 22;27(1):31. doi: 10.1186/s12875-026-03181-0.
PubMed 41572196Nilsagard YE, Smith DR, Soderqvist F, Strid EN, Wallin L. Achieving health-promotion practice in primary care using a multifaceted implementation strategy: a non-randomized parallel group study. Implement Sci Commun. 2025 Apr 7;6(1):36. doi: 10.1186/s43058-025-00723-y.
PubMed 40197376Nilsing Strid E, Wallin L, Nilsagard Y. Exploring expectations and readiness for healthy lifestyle promotion in Swedish primary health care: a qualitative analysis of managers, facilitators, and professionals. Scand J Prim Health Care. 2024 Mar;42(1):201-213. doi: 10.1080/02813432.2023.2301556. Epub 2024 Feb 7.
PubMed 38241166Strid EN, Wallin L, Nilsagard Y. Expectations on implementation of a health promotion practice using individually targeted lifestyle interventions in primary health care: a qualitative study. BMC Prim Care. 2023 Jun 16;24(1):122. doi: 10.1186/s12875-023-02079-5.
PubMed 37328813Strid EN, Wallin L, Nilsagard Y. Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study. JMIR Res Protoc. 2022 Aug 19;11(8):e37634. doi: 10.2196/37634.
PubMed 35984700
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Act in Time- Implementation of Health Promotive Work-way in Primary Care Setting - Evaluation of Effect- and Implementation Process (AcTi)
- ClinicalTrials.gov ID
- NCT04799860
- Acronym / sponsor ID
- AcTi / 275301
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- implementation, primary care, process evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Mar 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.
The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves.
Detailed description
Insufficient physical activity, hazardous use of alcohol, tobacco use and unhealthy eating habits increase the risk of cardiovascular diseases, cancer and type 2-diabetes. Health-promoting work reduces the disease risk and mortality and should thus be integrated in clinical care processes.
Despite support by the National guideline for prevention and treatment of unhealthy life-style habits, there is a chasm to bridge when integrating evidence into clinical practise. Prerequisites for changing work-ways are often underestimated and left to the individual co-workers to full fill on their own.
Too few patients are asked about life-style habits and too few receive evidence-based measures. The measures taken may also depend on sex, language, residence and caregiver's profession. The investigators strive to support the implementation of a health-promoting way of working that includes self-reporting of life-style habits before a visit and that takes measures for those with at least one unhealthy lifestyle habit.
The aim is to identify effective implementation strategies for health-promoting efforts in the primary care. The perceptions of barriers and opportunities when changing way of working from the target groups (leaders, co-workers, patients) will be used to enhance the possibility of successful implementation. Strategies are enhanced by theories of leading change. External and internal facilitators support the implementation.
The study will evaluate the effects and the implementation process at the level of leaders, patients, co-workers, facilitators and organisation in short (4-6 months) and long term (16-18 months).
The project provides generalizable knowledge on strategies to overcome the gap between evidence and praxis, contributing to utilize an existing synthesized knowledgebase regarding health-promoting and preventative workways in a Swedish primary care setting.
It is central for the health care system to identify successful implementation strategies in order to manage their future mission.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre-post-intervention design with control group will be used to evaluate intervention uptake and implementation process effectiveness from the perspective of managers, primary care professionals, patients, and organisation. Primary care settings in central Sweden will be supported in implementing a guideline-based health-promoting way of working including screening of life-style habits, measures taken according to evidence based recommendations and documentation. Strategies will include interactive education sessions, external and internal facilitators, audit and feedback, and tools from theories of leading change; tailored according to contextual and participant needs.
| Arm | Type | Receives |
|---|---|---|
| health promotive work-way | Experimental | Behavioral: health promotive work-waySix primary care units that voluntarily enrolls as experimental units. The units will receive implementation support based on previous research and tailored to the specific prerequisits and context for each unit. Strategies includes involvement of target groups; informationa and interactive education;use of external and internal facilitators tarined for the purpose; systematic feedback and learning dialogs during the project. The implementation support will take approximately 12 months. |
| Control | No intervention | –Six primary care centers of similar size and socioeconomic background in the population listed to each center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- being a caregiver meeting patients and/or
- being assigned a role as internal or external facilitator in the project
- 18 years or older
- visiting primary care units a specific time pre- or post implementation support
- : having one or more unhealthy life-style habit 18 years or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| health promotive work-wayClinical intervention: The patient is asked to fill in a screening form with life-style related questions. The caregiver takes adequate measures according to the recommendations of the national guideline and the filled in screeing form. The caregiver documents the measures taken. Implementation intervention as described previously: using tailored strategies to support implementation of the gudieline-based recommendations | Behavioural | health promotive work-way |
Primary outcome
Change and trend from baseline documented codes in medical records
Time frame: Change from baseline (6 months), through study completion up to 6 months after end of implementation support
specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity
Change and trend from baseline documented codes in medical records
Time frame: Change from baseline (6 months), through study completion up to 18 months after end of implementation support
specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity
Change in S-NoMAD score (Swedish translation of NoMAD
Time frame: Change from baseline S-Nomad score up to 4 to 6 months after end of study completion
23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring
Change in S-NoMAD score (Swedish translation of NoMAD
Time frame: Change from baseline S-Nomad score up to 16 to 18 months after end of study completion
23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring
3 secondary outcomes
Change in perceived clincial intervention by a study specific questionnaire
Time frame: Change from baseline up to 4 to 6 months after end of implementation support
Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.
Time frame: Change from baseline in AIM,IAM and FIM up to 4 to 6 months after end of implementation support
Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.
Time frame: Change from baseline in AIM,IAM and FIM up to 16 to18 months after end of implementation support
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 16 Dec 2025.
- Background: PubMed 25791983Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
- Background: PubMed 29385438Wandell PE, de Waard AM, Holzmann MJ, Gornitzki C, Lionis C, de Wit N, Sondergaard J, Sonderlund AL, Kral N, Seifert B, Korevaar JC, Schellevis FG, Carlsson AC. Barriers and facilitators among health professionals in primary care to prevention of cardiometabolic diseases: A systematic review. Fam Pract. 2018 Jul 23;35(4):383-398. doi: 10.1093/fampra/cmx137.
- Background: PubMed 31088483Nilsen P, Schildmeijer K, Ericsson C, Seing I, Birken S. Implementation of change in health care in Sweden: a qualitative study of professionals' change responses. Implement Sci. 2019 May 14;14(1):51. doi: 10.1186/s13012-019-0902-6.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 30509289Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Aberg AC. The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing. Implement Sci. 2018 Dec 4;13(1):146. doi: 10.1186/s13012-018-0835-5.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Background: PubMed 10474547Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
- Derived from this study: PubMed 42477730Nilsagard Y, Nilsing-Strid E. Sustainability of implementation of health-promotion practice in primary healthcare: a non-randomized parallel group study. BMC Health Serv Res. 2026 Jul 20;26(1):1006. doi: 10.1186/s12913-026-15103-y.
- Derived from this study: PubMed 41572196Karin B, Ylva N, Maria HN, Lars W, Emma NS. Act in time: primary health care professionals', internal facilitators', and managers' experiences of working health-promotively after a 12-month implementation intervention: a qualitative study using normalization process theory. BMC Prim Care. 2026 Jan 22;27(1):31. doi: 10.1186/s12875-026-03181-0.
- Derived from this study: PubMed 40197376Nilsagard YE, Smith DR, Soderqvist F, Strid EN, Wallin L. Achieving health-promotion practice in primary care using a multifaceted implementation strategy: a non-randomized parallel group study. Implement Sci Commun. 2025 Apr 7;6(1):36. doi: 10.1186/s43058-025-00723-y.
- Derived from this study: PubMed 38241166Nilsing Strid E, Wallin L, Nilsagard Y. Exploring expectations and readiness for healthy lifestyle promotion in Swedish primary health care: a qualitative analysis of managers, facilitators, and professionals. Scand J Prim Health Care. 2024 Mar;42(1):201-213. doi: 10.1080/02813432.2023.2301556. Epub 2024 Feb 7.
- Derived from this study: PubMed 37328813Strid EN, Wallin L, Nilsagard Y. Expectations on implementation of a health promotion practice using individually targeted lifestyle interventions in primary health care: a qualitative study. BMC Prim Care. 2023 Jun 16;24(1):122. doi: 10.1186/s12875-023-02079-5.
- Individual participant dataSharing planned: No. We don't collect individual data other than in the qualitative parts and we don't have ethical approval to share that
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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.
Ylva Nilsagård study director
University Health Care Research Center, Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health promotive work-way in people with Health Knowledge, Attitudes, Practice, run by Region Örebro County at 1 site in Sweden.
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 7 inclusion and 0 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 16 Dec 2025. 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 Sweden. 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?
Change and trend from baseline documented codes in medical records (time frame: Change from baseline (6 months), through study completion up to 6 months after end of implementation support). The study lists 4 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 NCT04799860, which also lists 13 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 16 Dec 2025.