FallNCT05308862
PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert
A study testing Care process for assessements of risks in people with Fall and Pressure Ulcer, run by Malmö University at 1 site in Sweden.
Trial summary
Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fall, Pressure Ulcer, Malnutrition
- What is being tested?
- Care process for assessements of risks
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSweden
- Study dates
- 19 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nursing homes registering in Senior Alert, which is a national quality registry
Who cannot join
- not meetin inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Malin Axelsson
Malmö, 205 06
Malin Axelsson, PhD, +46 406657960, malin.axelsson@mau.se
Christine Kumlien, PhD, +46406657430, christine.kumlien@mau.se
About this study
Official title: Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert
Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.
Read the detailed description
Study I The workshops (tentative plan) Groups of one-two nurse aides, one-two registered nurses and one-two managers from the nursing homes in the intervention group will form a workshop. In total, four-five workshops will be conducted. Each workshop will begin with an introductory framing of the workshop followed by addressed activities in four stations. The activities in the four stations are designed to give the participants possibility to be active in order to develop the intervention. The participants will write down conclusions of the discussions and the discussions will be audio recorded. The written documentation and the recorded discussions will constitute data and will be analyzed using content analysis.
Station one: the participants will discuss beforehand written questions based on the results of our previous studies, and literature in order to stimulate reflection and discussion. The participants will discuss how to work in a better/different way with risk assessments, care interventions and follow-ups that can contribute to improve the preventive work so that older persons are risk assessed, get the right care interventions planned, performed and evaluated to a greater extend. They will also discuss how the organization/routines around the preventive care process be developed. The participants will write down conclusions of the discussion.
Station two: the participants will discuss beforehand written questions concerning the preventive care process according to Senior Alert. The participants will work creatively to identify barriers and challenges in the preventive care process according to Senior Alert and how this process could be done in a smoother way. The participants will write down conclusions of the discussion.
Station three: the participants will discuss how the intervention could be design. Focus of the discussion will be on the core components of the intervention, e.g. context, activity, participants, time required and implementation. The participants will write down the discussion.
Station four: summary of the workshop.
The intervention (tentative plan) The intervention will be written out in detail after the workshops have been conducted, but below is a short description in accordance with the one in the Ethical approval.
The content of the intervention will focus on the importance of prevention of the risk for pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes and the preventive process in accordance with Senior Alert. The intervention could consist of; a work sheet to facilitate clinical decisions, new way of working, educational support, films or lectures, to meet nurse aides´, registered nurses´ and managers´ educational needs, fit into their organization and facilitate the preventive nursing care regarding these health risks.
Study II Feasibility/pilot testing the intervention The most suitable method will be applied to test and evaluate the intervention. A feasibility study could be carried out to evaluate if there are any uncertainties around the recruitment, data collection and retention or the intervention itself around the optimal content, delivery and acceptability. A pilot study could be carried out to address the main uncertainties in the development work and to indicate if further evaluation should be preceded or the intervention needs to be refined.
Evaluating the intervention To evaluate primary outcome measures, register data is going to be extracted from Senior Alert six months prior and one and six months after the intervention. Data on risk assessments and preventive interventions from the instruments available in Senior Alert (described in our previous studies) will be extracted. Additionally, background data regarding older persons in terms of biological sex, age and type of health care setting will be gathered from the registry.
Descriptive and analytic analysis will be performed in IBM SPSS Statistics Windows, Version 25 (Armonk, NY: IBM Corp) for comparisons between and within the intervention and control group.
To evaluate secondary outcome measurers all the nurse aides and registered nurses working in all the nursing homes included (both the intervention and the control group) will be invited to fill in questionnaires: the Psychosocial Aspects of Job Satisfaction questionnaire, the Perceived Stress Scale stress and the Stress of Conscience Questionnaire, at baseline (prior to the workshops) and six months after the intervention. Background data as age, gender, years of work experience and educational level will be collected. For comparisons between and within the intervention and control group before and after tests will be performed. IBM SPSS Statistics for Windows, Version 25 (Armonk, NY: IBM Corp) will be used to calculate descriptive and analytic statistics.
- Conditions
- Fall, Pressure Ulcer, Malnutrition, Oral Health
- Being tested
- Care process for assessements of risks
- Keywords
- Prevention, Older people, Nursing care, Complex intervention
- Medical subject headings
- Pressure Ulcer, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care process for assessements of risksBehavioural
Intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers. Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it .
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it. Receives: Behavioral: Care process for assessements of risks |
| Control | No intervention | Continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Measured: Baseline 6 months prior to intervention
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Measured: Baseline 6 months prior to intervention
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Measured: Baseline 6 months prior to intervention
Risk assessments and prevention care interventions focusing on poor oral health
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Measured: Baseline 6 months prior to intervention
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Measured: 1 month after intervention
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Measured: 1 month after intervention
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Measured: 1 month after intervention
Risk assessments and prevention care interventions focusing on poor oral health.
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Measured: 1 month after intervention
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Measured: 6 months after intervention
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Measured: 6 months after intervention
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Measured: 6 months after intervention
Risk assessments and prevention care interventions focusing on poor oral health.
Registry data from Senior Alert based on the following assessment: the Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Measured: 6 months after intervention
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Measured: 12 months after intervention
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Measured: 12 months after intervention
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Measured: 12 months after intervention
Risk assessments and prevention care interventions focusing on poor oral health.
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Measured: 12 months after intervention
Secondary outcomes (3)
Perceived Stress Scale stress (PSS)
Among nursing staff. 10 items scaled 0-4, higher scores indicate higher level of stress
Measured: Baseline and six months after intervention
Stress of Conscience (SCQ),
Among nursing staff. 9 items scaled 0-5, higher scores indicate higher level of SCQ.
Measured: Baseline and six months after intervention
Psychosocial Aspects of Job Satisfaction Questionnarie
Among nursing staff. 49 items, scaled 0-4, higher scores indicate higher level of psychosocial job satisfaction
Measured: Baseline and six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start19 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Malmö City
- Responsible party
- Principal investigator, Malin Axelsson, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308862
- Sponsor's protocol ID
- MalmoU 2022
- Status last verified
- May 2025
- First submitted
- 23 Feb 2022
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neziraj M, Kumlien C, Axelsson M. Codesigned STAIR OF KNOWLEDGE intervention to prevent pressure ulcers, malnutrition, poor oral health and falls in Swedish nursing homes: an external pilot cluster randomised controlled study. BMJ Open. 2026 Jun 25;16(6):e118018. doi: 10.1136/bmjopen-2026-118018.
PubMed 42350019Neziraj M, Axelsson M, Kumlien C, Hellman P, Andersson M. The STAIR OF KNOWLEDGE-a codesigned intervention to prevent pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes in Sweden: development of a complex intervention. BMJ Open. 2023 Aug 10;13(8):e072453. doi: 10.1136/bmjopen-2023-072453.
PubMed 37562934
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert
- ClinicalTrials.gov ID
- NCT05308862
- Acronym / sponsor ID
- MalmoU 2022
- Conditions
- Fall, Pressure Ulcer, Malnutrition, Oral Health
- Keywords
- Prevention, Older people, Nursing care, Complex intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Malmö City
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Apr 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.
Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.
Detailed description
Study I The workshops (tentative plan) Groups of one-two nurse aides, one-two registered nurses and one-two managers from the nursing homes in the intervention group will form a workshop. In total, four-five workshops will be conducted. Each workshop will begin with an introductory framing of the workshop followed by addressed activities in four stations. The activities in the four stations are designed to give the participants possibility to be active in order to develop the intervention. The participants will write down conclusions of the discussions and the discussions will be audio recorded. The written documentation and the recorded discussions will constitute data and will be analyzed using content analysis.
Station one: the participants will discuss beforehand written questions based on the results of our previous studies, and literature in order to stimulate reflection and discussion. The participants will discuss how to work in a better/different way with risk assessments, care interventions and follow-ups that can contribute to improve the preventive work so that older persons are risk assessed, get the right care interventions planned, performed and evaluated to a greater extend. They will also discuss how the organization/routines around the preventive care process be developed. The participants will write down conclusions of the discussion.
Station two: the participants will discuss beforehand written questions concerning the preventive care process according to Senior Alert. The participants will work creatively to identify barriers and challenges in the preventive care process according to Senior Alert and how this process could be done in a smoother way. The participants will write down conclusions of the discussion.
Station three: the participants will discuss how the intervention could be design. Focus of the discussion will be on the core components of the intervention, e.g. context, activity, participants, time required and implementation. The participants will write down the discussion.
Station four: summary of the workshop.
The intervention (tentative plan) The intervention will be written out in detail after the workshops have been conducted, but below is a short description in accordance with the one in the Ethical approval.
The content of the intervention will focus on the importance of prevention of the risk for pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes and the preventive process in accordance with Senior Alert. The intervention could consist of; a work sheet to facilitate clinical decisions, new way of working, educational support, films or lectures, to meet nurse aides´, registered nurses´ and managers´ educational needs, fit into their organization and facilitate the preventive nursing care regarding these health risks.
Study II Feasibility/pilot testing the intervention The most suitable method will be applied to test and evaluate the intervention. A feasibility study could be carried out to evaluate if there are any uncertainties around the recruitment, data collection and retention or the intervention itself around the optimal content, delivery and acceptability. A pilot study could be carried out to address the main uncertainties in the development work and to indicate if further evaluation should be preceded or the intervention needs to be refined.
Evaluating the intervention To evaluate primary outcome measures, register data is going to be extracted from Senior Alert six months prior and one and six months after the intervention. Data on risk assessments and preventive interventions from the instruments available in Senior Alert (described in our previous studies) will be extracted. Additionally, background data regarding older persons in terms of biological sex, age and type of health care setting will be gathered from the registry.
Descriptive and analytic analysis will be performed in IBM SPSS Statistics Windows, Version 25 (Armonk, NY: IBM Corp) for comparisons between and within the intervention and control group.
To evaluate secondary outcome measurers all the nurse aides and registered nurses working in all the nursing homes included (both the intervention and the control group) will be invited to fill in questionnaires: the Psychosocial Aspects of Job Satisfaction questionnaire, the Perceived Stress Scale stress and the Stress of Conscience Questionnaire, at baseline (prior to the workshops) and six months after the intervention. Background data as age, gender, years of work experience and educational level will be collected. For comparisons between and within the intervention and control group before and after tests will be performed. IBM SPSS Statistics for Windows, Version 25 (Armonk, NY: IBM Corp) will be used to calculate descriptive and analytic statistics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Care process for assessements of risksCluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it. |
| Control | No intervention | –Continue with usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nursing homes registering in Senior Alert, which is a national quality registry
Key exclusion criteria (1 listed)
- not meetin inclusion criteria
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 |
|---|---|---|
| Care process for assessements of risksIntervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers. Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it . | Behavioural | Intervention |
Primary outcome
Risk assessments and prevention care interventions focusing on falls.
Time frame: Baseline 6 months prior to intervention
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Time frame: Baseline 6 months prior to intervention
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Time frame: Baseline 6 months prior to intervention
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health
Time frame: Baseline 6 months prior to intervention
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Risk assessments and prevention care interventions focusing on falls.
Time frame: 1 month after intervention
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Time frame: 1 month after intervention
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Time frame: 1 month after intervention
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health.
Time frame: 1 month after intervention
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Risk assessments and prevention care interventions focusing on falls.
Time frame: 6 months after intervention
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Time frame: 6 months after intervention
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Time frame: 6 months after intervention
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health.
Time frame: 6 months after intervention
Registry data from Senior Alert based on the following assessment: the Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Risk assessments and prevention care interventions focusing on falls.
Time frame: 12 months after intervention
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Time frame: 12 months after intervention
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Time frame: 12 months after intervention
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health.
Time frame: 12 months after intervention
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
3 secondary outcomes
Perceived Stress Scale stress (PSS)
Time frame: Baseline and six months after intervention
Stress of Conscience (SCQ),
Time frame: Baseline and six months after intervention
Psychosocial Aspects of Job Satisfaction Questionnarie
Time frame: Baseline and six months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Derived from this study: PubMed 42350019Neziraj M, Kumlien C, Axelsson M. Codesigned STAIR OF KNOWLEDGE intervention to prevent pressure ulcers, malnutrition, poor oral health and falls in Swedish nursing homes: an external pilot cluster randomised controlled study. BMJ Open. 2026 Jun 25;16(6):e118018. doi: 10.1136/bmjopen-2026-118018.
- Derived from this study: PubMed 37562934Neziraj M, Axelsson M, Kumlien C, Hellman P, Andersson M. The STAIR OF KNOWLEDGE-a codesigned intervention to prevent pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes in Sweden: development of a complex intervention. BMJ Open. 2023 Aug 10;13(8):e072453. doi: 10.1136/bmjopen-2023-072453.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care process for assessements of risks in people with Fall and Pressure Ulcer, run by Malmö University 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 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: looking for participants now, as of the sponsor's last update on 9 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malin Axelsson, Phd (+46406657960, malin.axelsson@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk assessments and prevention care interventions focusing on falls. (time frame: Baseline 6 months prior to intervention). The study lists 16 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 NCT05308862, which also lists 2 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 9 May 2025.