Quality of LifeNCT06807060
A Municipality Implemented Behavioural Intervention to Improve Quality of Life Among Older Adults
A study testing 'Light, activity and sleep in my daily life' intervention in people with Quality of Life, run by Lund University at 4 sites in Sweden.
Trial summary
Ageing is associated with circadian rhythm sleep disorders, poor sleep at night, less physical activity and more time spent indoors, affecting the wellbeing of older adults. Their sleep and mood could benefit from daytime outdoor physical activity, exposure to daylight, better indoor lighting and sleep routines. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- 'Light, activity and sleep in my daily life' intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesSweden
- Study dates
- 15 May 2024to 16 Oct 2026
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 70 and over, ambulatory and sighted,
- Swedish speaking,
- living independently in one-person households in ordinary apartments and
- receiving no or limited home care services.
Who cannot join
- Study participants will be excluded if they have any condition that makes it difficult to participate.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Steven M Schmidt, PhD contact
Sweden4 sites, 2 recruiting
- Recruiting
Gothenburg Municipality
Gothenburg
- Not yet recruiting
Jönköping Municipality
Jönköping
- Active, not recruiting
Lund Municipality
Lund
- Active, not recruiting
Malmö Municipality
Malmö
About this study
Official title: A Municipality Implemented Behavioural Intervention to Improve Quality of Life Among Older Adults: Protocol for a Mixed-Methods Pilot Case Study
Ageing is associated with circadian rhythm sleep disorders, poor sleep at night, less physical activity and more time spent indoors, affecting the wellbeing of older adults. Their sleep and mood could benefit from daytime outdoor physical activity, exposure to daylight, better indoor lighting and sleep routines. However, maintaining or increasing one's physical activity can be challenging depending on individual behavioural conditions, e.g., having the physical and cognitive capacity (capability), finding the activity enjoyable and relevant to one's needs (motivation), and having a supportive social and physical environment (opportunity), such as a walk-friendly environment. To address these challenges, a complex behavioural intervention was developed. The intervention is delivered as a web-based course ('Light, activity and sleep in my daily life', LAS) that targets light-related behaviour, outdoor walking and sleep behaviour among community-dwelling older adults. This protocol describes a pilot case study aiming to evaluate the usability and usefulness of the LAS intervention, the intervention outcomes and whether changes to routines are sustained.
Eligible intervention participants (target N=40) are Swedish-speaking adults (≥ 70 years), living in one-person households in apartments in four municipalities. Participants complete questionnaires assessing intervention outcome measures (e.g., quality of life), are interviewed about their daily routines, and wear an accelerometer which tracks activity and rest at the baseline. Participants then enrol in a 9-week course, including self-studies at home and four physical meetings at the senior citizen meeting point. Baseline measures are repeated after the course, at 3, 6 and 10 months after baseline. In addition, participants evaluate the intervention's usability and usefulness after the course at 3 months and are interviewed at 6 months after baseline about perceived enablers and inhibitors to daytime outdoor walking.
Results will inform a subsequent larger case study focused on optimising the LAS intervention's content and delivery procedures to enable an intervention better integrated into municipal health promotion services/strategies. An anticipated long-term outcome is continued active ageing and independence.
Read the detailed description
Development of the intervention: 'Light, activity and sleep in my daily life' The 'Light, activity and sleep in my daily life' (LAS) intervention directed at older adults was developed to promote wellbeing through increased physical activity, enhanced mood and sleep, and improved lighting and darkness conditions at home. The intervention focuses on health promotion through changes to routines (light-related behaviour, outdoor physical activity and sleep behaviour) and environmental proactivity. The latter refers to persons who modify their environments to live a healthy and independent life. Environmental modifications include interior lighting, filtering daylight and blocking light at night, without risking accidents when getting up at night, and furniture arrangement.
The intervention is complex in that it considers multiple factors (e.g., light-related behaviour, physical activity and sleep behaviour) and components (e.g., cognitive goal setting and implementation. The intervention addresses self-identified needs, which can make it more effective.
The intervention is delivered as a web-based course on a digital platform and includes one introductory physical meeting and three additional physical meetings. Course material is placed in nine modules covering electric lighting, daylight, physical activity outdoors and sleep. Each completed module ends with a brief online evaluation. Besides online material, the course includes a test kit containing light bulbs, a sleep mask, a checklist for the room inventory, a cap, a notebook, and a sleep diary. The purpose of the test kit is to encourage experimentation and provide handouts and printed copies to facilitate the completion of assignments.
In 2021-2022 usability evaluations of a first version were conducted in a full-scale model of an apartment by two sets of participants: in a first round by experts and in a second round by pensioners representing the target users (community-dwelling adults aged 70 and over). Intervention content and design features were refined based on their feedback. In autumn 2022, intervention usability and study feasibility were evaluated in real-world homes by eight participants aged 71-84 (27). The conclusion was that only minor changes to the intervention were needed based on participants' feedback. Regarding the locality for the physical meetings, the researchers found the municipality's senior citizen meeting point suitable for the purpose, and participants appreciated that meetings were at the same place. One finding was the need to extend the time for recruitment, and advertising in the local newspapers should be considered to reach a wider group of potential volunteers.
Based on the study findings from the field, the following design changes were made to the online intervention content: the weekly evaluation form was revised so intervention participants can provide textual feedback to the course leader/interventionist; instructions for downloading the light meter app to the phone were revised; and text links were updated.
This pilot case study aims to evaluate the usability and acceptance of the LAS intervention, the intervention outcomes and whether changes to routines are sustained. In addition, perceived enablers and inhibitors to daytime outdoor walking will be identified.
The primary objectives are as follows:
- To evaluate the usability and usefulness of the intervention, that is, determine if the online intervention content is easy to use and the intervention is useful for older adults 70 and over.
- To evaluate the acceptance of intervention delivery procedures (locality of physical meetings, recruitment) to municipal staff (potential service providers).
- To identify motivation/capabilities/opportunities relating to outdoor physical activity (e.g., perceived enablers and inhibitors to daytime outdoor walking).
- To develop further training material for future course leaders/interventionists in dialogue with the municipal partners.
A secondary objective is to gain insight into the potential effectiveness of the intervention in terms of activity and rest patterns, mood, sleep quality, behavioural skills and quality of life.
- Conditions
- Quality of Life
- Being tested
- 'Light, activity and sleep in my daily life' intervention
- Keywords
- Complex intervention, Behavioural change, Environmental proactivity, Older adults, Usability, Quality of Life, Daytime outdoor walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Light, activity and sleep in my daily life' interventionBehavioural
The intervention is complex in that it considers multiple factors (e.g., light-related behaviour, physical activity and sleep behaviour) and multiple components (e.g., cognitive goal setting and implementation).
The intervention is delivered as a web-based course on a digital learning platform. Course material is placed in nine modules covering electric lighting, daylight, physical activity outdoors and sleep. Besides online material, the course includes a test kit containing light bulbs, a sleep mask, a checklist for the room inventory, a cap, a notebook, and a sleep diary. The purpose of the test kit is to encourage experimentation and provide handouts and printed copies to facilitate the completion of assignments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants receive the same intervention, including noninvasive approaches (both education and behavioural). Receives: Behavioral: 'Light, activity and sleep in my daily life' intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
System Usability Scale score. The usability of the intervention, that is, if the online content is easy for the intervention participants to use, will be evaluated through a usability testing questionnaire (perceptions of complexity, integration of functions, consistency). Following published instructions on scoring of the 10-item System Usability Scale (SUS), a total usability score will be calculated ranging from 0 to 100. Higher SUS scores indicate greater usability. Based on empirical evaluations of the SUS, a SUS score below 50 indicates usability difficulties, while scores in the 70s and 80s are considered promising.
Measured: At one timepoint: 3 months after baseline
Secondary outcomes (8)
Mood
Short Swedish Core Affect Scales. Two scales measuring two dimensions, 'valence' (including three adjective pairs) and 'activation' (including three adjective pairs). Scores for each dimension can range from 1 to 9, with higher scores indicating better mood.
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline
Sleep quality
Sleep Disturbance instrument, Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0. Assessing sleep disturbance, including four items. The total raw score can range from 32 to 73.3, with higher scores indicating worse sleep quality.
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline
Behavioural skill
A New General Self-efficacy Scale. Assessing general self-efficacy, including eight items (goal achievement, task accomplishment, obtaining important outcomes, succeeding at most any endeavour, overcoming challenges, effective performance, doing tasks well, performing well even when things are tough). The global score can range from 1 to 5, with higher scores indicating higher self-efficacy.
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline
Quality of life
World Health Organization Quality of Life (BREF) questionnaire. Assessing quality of life over four domains (physical health, psychological, social relationships, environment). Scores for each domain can range from zero to 100, with higher scores indicating better quality of life.
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline
Sleep (activity and rest patterns)
Performance-based measure using a wrist-worn accelerometer (ActiGraph wGT3X-BT, ActiGraph LLC, Pensacola, FL)
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)
Physical activity
Performance-based measure using a wrist-worn accelerometer (ActiGraph wGT3X-BT, ActiGraph LLC, Pensacola, FL). Assessing light, moderate-to-vigorous and vigorous physical activity (minutes).
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 8 days (not used during shower)
Sedentary behaviour
Performance-based measure using a wrist-worn accelerometer (ActiGraph wGT3X-BT, ActiGraph LLC, Pensacola, FL). Assessing sedentary time (minutes).
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)
Steps
Performance-based measure using a wrist-worn accelerometer (ActiGraph wGT3X-BT, ActiGraph LLC, Pensacola, FL). Assessing the number of steps.
Measured: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start15 May 2024
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Oct 2026 (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 Quality of LifeStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807060
- Sponsor's protocol ID
- 2024-01607-01
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerhardsson KM, Hassan M, Tornberg AB, Schmidt SM. Usability and feasibility of an online intervention for older adults to support changes to routines and the home ('Light, activity and sleep in my daily life'). BMC Public Health. 2024 Oct 14;24(1):2808. doi: 10.1186/s12889-024-20309-y.
PubMed 39402489Gerhardsson KM, Brogardh C, Tornberg AB, Hellblom E, Schmidt SM. A municipality implemented behavioural intervention to improve quality of life among older adults: protocol for a mixed-methods pilot case study. Pilot Feasibility Stud. 2026 Mar 14;12(1):47. doi: 10.1186/s40814-026-01795-w.
PubMed 41827051
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Municipality Implemented Behavioural Intervention to Improve Quality of Life Among Older Adults: Protocol for a Mixed-Methods Pilot Case Study
- ClinicalTrials.gov ID
- NCT06807060
- Acronym / sponsor ID
- 2024-01607-01
- Conditions
- Quality of Life
- Keywords
- Complex intervention, Behavioural change, Environmental proactivity, Older adults, Usability, Quality of Life, Daytime outdoor walking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 4 Feb 2025 (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.
Ageing is associated with circadian rhythm sleep disorders, poor sleep at night, less physical activity and more time spent indoors, affecting the wellbeing of older adults. Their sleep and mood could benefit from daytime outdoor physical activity, exposure to daylight, better indoor lighting and sleep routines. However, maintaining or increasing one's physical activity can be challenging depending on individual behavioural conditions, e.g., having the physical and cognitive capacity (capability), finding the activity enjoyable and relevant to one's needs (motivation), and having a supportive social and physical environment (opportunity), such as a walk-friendly environment. To address these challenges, a complex behavioural intervention was developed. The intervention is delivered as a web-based course ('Light, activity and sleep in my daily life', LAS) that targets light-related behaviour, outdoor walking and sleep behaviour among community-dwelling older adults. This protocol describes a pilot case study aiming to evaluate the usability and usefulness of the LAS intervention, the intervention outcomes and whether changes to routines are sustained.
Eligible intervention participants (target N=40) are Swedish-speaking adults (≥ 70 years), living in one-person households in apartments in four municipalities. Participants complete questionnaires assessing intervention outcome measures (e.g., quality of life), are interviewed about their daily routines, and wear an accelerometer which tracks activity and rest at the baseline. Participants then enrol in a 9-week course, including self-studies at home and four physical meetings at the senior citizen meeting point. Baseline measures are repeated after the course, at 3, 6 and 10 months after baseline. In addition, participants evaluate the intervention's usability and usefulness after the course at 3 months and are interviewed at 6 months after baseline about perceived enablers and inhibitors to daytime outdoor walking.
Results will inform a subsequent larger case study focused on optimising the LAS intervention's content and delivery procedures to enable an intervention better integrated into municipal health promotion services/strategies. An anticipated long-term outcome is continued active ageing and independence.
Detailed description
Development of the intervention: 'Light, activity and sleep in my daily life' The 'Light, activity and sleep in my daily life' (LAS) intervention directed at older adults was developed to promote wellbeing through increased physical activity, enhanced mood and sleep, and improved lighting and darkness conditions at home. The intervention focuses on health promotion through changes to routines (light-related behaviour, outdoor physical activity and sleep behaviour) and environmental proactivity. The latter refers to persons who modify their environments to live a healthy and independent life. Environmental modifications include interior lighting, filtering daylight and blocking light at night, without risking accidents when getting up at night, and furniture arrangement.
The intervention is complex in that it considers multiple factors (e.g., light-related behaviour, physical activity and sleep behaviour) and components (e.g., cognitive goal setting and implementation. The intervention addresses self-identified needs, which can make it more effective.
The intervention is delivered as a web-based course on a digital platform and includes one introductory physical meeting and three additional physical meetings. Course material is placed in nine modules covering electric lighting, daylight, physical activity outdoors and sleep. Each completed module ends with a brief online evaluation. Besides online material, the course includes a test kit containing light bulbs, a sleep mask, a checklist for the room inventory, a cap, a notebook, and a sleep diary. The purpose of the test kit is to encourage experimentation and provide handouts and printed copies to facilitate the completion of assignments.
In 2021-2022 usability evaluations of a first version were conducted in a full-scale model of an apartment by two sets of participants: in a first round by experts and in a second round by pensioners representing the target users (community-dwelling adults aged 70 and over). Intervention content and design features were refined based on their feedback. In autumn 2022, intervention usability and study feasibility were evaluated in real-world homes by eight participants aged 71-84 (27). The conclusion was that only minor changes to the intervention were needed based on participants' feedback. Regarding the locality for the physical meetings, the researchers found the municipality's senior citizen meeting point suitable for the purpose, and participants appreciated that meetings were at the same place. One finding was the need to extend the time for recruitment, and advertising in the local newspapers should be considered to reach a wider group of potential volunteers.
Based on the study findings from the field, the following design changes were made to the online intervention content: the weekly evaluation form was revised so intervention participants can provide textual feedback to the course leader/interventionist; instructions for downloading the light meter app to the phone were revised; and text links were updated.
This pilot case study aims to evaluate the usability and acceptance of the LAS intervention, the intervention outcomes and whether changes to routines are sustained. In addition, perceived enablers and inhibitors to daytime outdoor walking will be identified.
The primary objectives are as follows:
- To evaluate the usability and usefulness of the intervention, that is, determine if the online intervention content is easy to use and the intervention is useful for older adults 70 and over.
- To evaluate the acceptance of intervention delivery procedures (locality of physical meetings, recruitment) to municipal staff (potential service providers).
- To identify motivation/capabilities/opportunities relating to outdoor physical activity (e.g., perceived enablers and inhibitors to daytime outdoor walking).
- To develop further training material for future course leaders/interventionists in dialogue with the municipal partners.
A secondary objective is to gain insight into the potential effectiveness of the intervention in terms of activity and rest patterns, mood, sleep quality, behavioural skills and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 'Light, activity and sleep in my daily life' interventionAll participants receive the same intervention, including noninvasive approaches (both education and behavioural). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 70 and over, ambulatory and sighted,
- Swedish speaking,
- living independently in one-person households in ordinary apartments and
- receiving no or limited home care services.
Key exclusion criteria (1 listed)
- Study participants will be excluded if they have any condition that makes it difficult to participate.
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 |
|---|---|---|
| 'Light, activity and sleep in my daily life' interventionThe intervention is complex in that it considers multiple factors (e.g., light-related behaviour, physical activity and sleep behaviour) and multiple components (e.g., cognitive goal setting and implementation). The intervention is delivered as a web-based course on a digital learning platform. Course material is placed in nine modules covering electric lighting, daylight, physical activity outdoors and sleep. Besides online material, the course includes a test kit containing light bulbs, a sleep mask, a checklist for the room inventory, a cap, a notebook, and a sleep diary. The purpose of the test kit is to encourage experimentation and provide handouts and printed copies to facilitate the completion of assignments. | Behavioural | Intervention |
Primary outcome
Usability
Time frame: At one timepoint: 3 months after baseline
System Usability Scale score. The usability of the intervention, that is, if the online content is easy for the intervention participants to use, will be evaluated through a usability testing questionnaire (perceptions of complexity, integration of functions, consistency). Following published instructions on scoring of the 10-item System Usability Scale (SUS), a total usability score will be calculated ranging from 0 to 100. Higher SUS scores indicate greater usability. Based on empirical evaluations of the SUS, a SUS score below 50 indicates usability difficulties, while scores in the 70s and 80s are considered promising.
8 secondary outcomes
Mood
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline
Sleep quality
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline
Behavioural skill
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline
Quality of life
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline
Sleep (activity and rest patterns)
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)
Physical activity
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 8 days (not used during shower)
Sedentary behaviour
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)
Steps
Time frame: At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)
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 4 Feb 2025.
- Background: PubMed 39402489Gerhardsson KM, Hassan M, Tornberg AB, Schmidt SM. Usability and feasibility of an online intervention for older adults to support changes to routines and the home ('Light, activity and sleep in my daily life'). BMC Public Health. 2024 Oct 14;24(1):2808. doi: 10.1186/s12889-024-20309-y.
- Derived from this study: PubMed 41827051Gerhardsson KM, Brogardh C, Tornberg AB, Hellblom E, Schmidt SM. A municipality implemented behavioural intervention to improve quality of life among older adults: protocol for a mixed-methods pilot case study. Pilot Feasibility Stud. 2026 Mar 14;12(1):47. doi: 10.1186/s40814-026-01795-w.
- 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.
Steven M Schmidt, PhD contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Light, activity and sleep in my daily life' intervention in people with Quality of Life, run by Lund University at 4 sites 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 4 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Kiran M Gerhardsson, PhD (+46 767 23 27 56, kiran.maini_gerhardsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: At one timepoint: 3 months after baseline). 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 NCT06807060, 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 4 Feb 2025.