BehaviorSMARTNCT04953364
Self-Management for Amputee Rehabilitation Using Technology.
A study testing SMART in people with Behavior and Amputation, run by University of British Columbia at 1 site in Canada.
Trial summary
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Amputation, Lower Limb Amputation Above Knee (Injury)
- What is being tested?
- SMART
- 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
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2022to 1 Feb 2026
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a unilateral LLA (transtibial or transfemoral) due to diabetes or vascular disease
- Received initial casting of their prosthesis within the past 2 years
- Be aged ≥ 50 years (85% of adults with LLA)
- Self-identifies as being able to speak and read English.
- Has access to computer or tablet and internet.
- Individuals living in British Columbia or Ontario, Canada.
Who cannot join
- Substantial health conditions (e.g., congestive heart failure, diagnosed dementia)
- Those anticipating further surgery (e.g. LLA revision) as identified by our study sites' physiatrists
- an inability to use a tablet (e.g. using hands for typing).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
William C Miller, PhD, +1 (604) 312-5245, bill.miller@ubc.ca
About this study
Official title: Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.
Read the detailed description
Importance: Amputation is a stressful experience which causes daily fluctuations in psychological and physical functioning and social interactions. Yearly, more than 7300 patients are admitted to hospitals nationwide for lower limb amputation (LLA), with the majority (86%) occurring in adults over 50. Consequences of LLA, such as a change in body image, mobility restrictions, and pain, may lead to depression, social isolation and decreased quality of life. Clients may lack coping strategies, educational resources, or access to rehabilitation services, especially for rural living Canadians. Online eHealth approaches, including the use of tablets, are considered effective approaches for delivering self-management programs, while addressing logistical barriers. Using a participatory action research approach, an eHealth platform for individuals with LLA called Self-Management for Amputee Rehabilitation using Technology (SMART) was co-designed and co-developed.
The investigators' goal is to determine the effectiveness and retention effect of SMART in community dwelling older adults (≥50yrs) with unilateral LLA, while documenting implementation factors. the hypothesis driving this investigation is that older adults with LLA who receive SMART intervention, compared with paper-based education as a control group, will have greater positive changes in confidence in their ambulation and walking capacity.
Methods: Using a Type 1 Effectiveness-Implementation Hybrid Design randomized controlled trial (RCT), the 6-week effectiveness and 4-week retention effect of SMART will be assessed on patient-relevant outcomes, and implementation. A volunteer sample of men and women, aged ≥50 years, with unilateral transtibial or transfemoral LLA, who started casting of their initial prosthetic limb, with command of English will be recruited from BC and ON. The sample will be randomly allocated to the experimental (SMART) (n=41) or control group (n=41), with a ratio of 1:1. Both groups will receive usual care, provided by their healthcare providers. The experimental group will receive a SMART enabled tablet for daily use (6 weeks). SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website. The control group will receive a care booklet and weekly contacts. All data collection will be conducted using Zoom online platform, hosted by University of British Columbia. Confidence in ambulation will be measured by Ambulatory Self-Confidence Questionnaire (ASCQ) and Walking capacity will be assessed using the Timed Up and Go test (TUG)--these measures will be conducted under remote supervision via Zoom. Five elements of implementation will be assessed including, reach (target population), effectiveness (effects of SMART), adoption (by setting/staff), implementation (dose delivered and fidelity), and maintenance of the behavior (in target population and settings). Online one-on-one semi-structured interviews with 20 participants (SMART group) will be used to assess the participants' experience. The interviews will be conducted using Zoom video calls. Analyses: Outcomes will be disaggregated for sex and gender differences. Between- and within- group differences will be assessed by covariance analysis. Thematic analyses of qualitative data will explore participants' experience.
Noah Tregobov's role will be that of the research assistant. Elham Esfandiari will be coordinating most of the research as a graduate student.
William Miller is the PI and will oversee the overall execution of the project. All other team members will serve as resources for information, recruitment, research design, etc. but will not directly interact with participants.
- Conditions
- Behavior, Amputation, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Knee
- Being tested
- SMART, Control
- Medical subject headings
- Behavior, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTBehavioural
SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website.
ControlBehavioural
The control group will receive a care booklet and weekly contacts for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SMART | Experimental | The experimental group will receive access to SMART online platform (6 weeks). SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. SMART will also allow asynchronous contact with trainers through a secure website. Receives: Behavioral: SMART |
| Control | Active comparator | The control group will receive a care booklet and weekly contacts for 6 weeks. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG, Timed Up and Go test
The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.
Measured: Ten weeks
ASCQ, the Ambulatory Self-Confidence Questionnaire
This questionnaire measures how confident you are in your ability to walk.
Type of Administration:
Self-Report.
Response Scale:
0 (not confident at all) - 10 (extremely confident)
Scoring:
Participants' total score is derived by calculating a mean score
Interpretation:
Higher scores = higher level of self-confidence regarding ambulation
Measured: Ten weeks
Secondary outcomes (12)
Self-Report Habit Index (SRHI)
12-item questionnaire based on the 7-point Likert scale with the range of total score between 0 to 84, which higher scores show the stronger habit strength
Measured: Ten weeks
Physical Activity Identity (PAI)
Physical activity self-identification 7 point likert scale. Higher score = higher physical activity identification PAI items relate to how much the participant identifies with being physically active.
Measured: Ten weeks
The Revised Amputee Body Image Scale (ABIS-R)
This questionnaire is designed to measure how you see and feel about your body image. It is not a test so there are no right or wrong answers. Please answer each item as carefully and as accurately as you can by placing the appropriate number beside each question as follows.
Scale of 0, 1, 2. 0 = none of the time, 2 = most of the time High scores indicate high body image disturbance.
Measured: Ten weeks
Center for Epidemiologic Studies Depression Scale (CES-D)
Below is a list of the ways you might have felt or behaved. Please tell me how often you have felt this way during the past week.
20 items Scoring: 0, 1, 2, 3 representing "rarely" to "most of the time", respectively. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measured: Ten weeks
Self-Report Habit Index (SRH)
Self report of limb cleaning tendencies
Measured: Ten weeks
Activities Specific Balance Confidence (ABC) Scale
Assesses confidence in balance during different activities 16 items Each item is rated from 0% - 100% 100% indicates the participant is "completely confident" in the activity described in the item.
Measured: Ten weeks
Residual limb pain, phantom pain, and non-painful phantom limb sensations
Residual limb pain, phantom pain, and non-painful phantom limb sensations
Participants rate their pain on each of the 3 items. Scale of 1-10 Higher score means greater reported pain
Measured: Ten weeks
Short Musculoskeletal Function Assessment (SMFA)
Items 1-34 of a questionnaire to assess the difficulty with daily activities and experiencing problems because of injury.
Measured: Ten weeks
Euro Quality of Life
Five Level Instrument (EQ-5D-5L) assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Ten weeks
Tenacious goal pursuit (TGP)
Assesses tendency to persist and increase effort in pursuing goals facing obstacles
Measured: Ten weeks
Action Planning Scale (AP)
Assesses whether people had formed a plan which links goal-directed behavior to environmental cues by indentifying when, where and how to act.
We will specifically assess for 'exercising', 'skin monitoring', and 'cleaning the prosthesis'.
Measured: Ten weeks
Self-Management Assessment Scale (SMASc)
Assesses five domains that are important for an effective self-management, including "knowledge, goals for future, daily routines, emotional adjustment, and social support".
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start14 Oct 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C Miller, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953364
- Sponsor's protocol ID
- H20-03316
- Acronym
- SMART
- Status last verified
- Jul 2024
- First submitted
- 17 May 2021
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esfandiari E, Miller WC, King S, Payne M, Mortenson WB, Underwood H, MacKay C, Ashe MC. Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss. PLoS One. 2023 Mar 23;18(3):e0278418. doi: 10.1371/journal.pone.0278418. eCollection 2023.
PubMed 36952517
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT04953364
- Acronym / sponsor ID
- SMART / H20-03316
- Conditions
- Behavior, Amputation, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 8 Jul 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.
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.
Detailed description
Importance: Amputation is a stressful experience which causes daily fluctuations in psychological and physical functioning and social interactions. Yearly, more than 7300 patients are admitted to hospitals nationwide for lower limb amputation (LLA), with the majority (86%) occurring in adults over 50. Consequences of LLA, such as a change in body image, mobility restrictions, and pain, may lead to depression, social isolation and decreased quality of life. Clients may lack coping strategies, educational resources, or access to rehabilitation services, especially for rural living Canadians. Online eHealth approaches, including the use of tablets, are considered effective approaches for delivering self-management programs, while addressing logistical barriers. Using a participatory action research approach, an eHealth platform for individuals with LLA called Self-Management for Amputee Rehabilitation using Technology (SMART) was co-designed and co-developed.
The investigators' goal is to determine the effectiveness and retention effect of SMART in community dwelling older adults (≥50yrs) with unilateral LLA, while documenting implementation factors. the hypothesis driving this investigation is that older adults with LLA who receive SMART intervention, compared with paper-based education as a control group, will have greater positive changes in confidence in their ambulation and walking capacity.
Methods: Using a Type 1 Effectiveness-Implementation Hybrid Design randomized controlled trial (RCT), the 6-week effectiveness and 4-week retention effect of SMART will be assessed on patient-relevant outcomes, and implementation. A volunteer sample of men and women, aged ≥50 years, with unilateral transtibial or transfemoral LLA, who started casting of their initial prosthetic limb, with command of English will be recruited from BC and ON. The sample will be randomly allocated to the experimental (SMART) (n=41) or control group (n=41), with a ratio of 1:1. Both groups will receive usual care, provided by their healthcare providers. The experimental group will receive a SMART enabled tablet for daily use (6 weeks). SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website. The control group will receive a care booklet and weekly contacts. All data collection will be conducted using Zoom online platform, hosted by University of British Columbia. Confidence in ambulation will be measured by Ambulatory Self-Confidence Questionnaire (ASCQ) and Walking capacity will be assessed using the Timed Up and Go test (TUG)--these measures will be conducted under remote supervision via Zoom. Five elements of implementation will be assessed including, reach (target population), effectiveness (effects of SMART), adoption (by setting/staff), implementation (dose delivered and fidelity), and maintenance of the behavior (in target population and settings). Online one-on-one semi-structured interviews with 20 participants (SMART group) will be used to assess the participants' experience. The interviews will be conducted using Zoom video calls. Analyses: Outcomes will be disaggregated for sex and gender differences. Between- and within- group differences will be assessed by covariance analysis. Thematic analyses of qualitative data will explore participants' experience.
Noah Tregobov's role will be that of the research assistant. Elham Esfandiari will be coordinating most of the research as a graduate student.
William Miller is the PI and will oversee the overall execution of the project. All other team members will serve as resources for information, recruitment, research design, etc. but will not directly interact with participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| SMART | Experimental | Behavioral: SMARTThe experimental group will receive access to SMART online platform (6 weeks). SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. SMART will also allow asynchronous contact with trainers through a secure website. |
| Control | Active comparator | Behavioral: ControlThe control group will receive a care booklet and weekly contacts for 6 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a unilateral LLA (transtibial or transfemoral) due to diabetes or vascular disease
- Received initial casting of their prosthesis within the past 2 years
- Be aged ≥ 50 years (85% of adults with LLA)
- Self-identifies as being able to speak and read English.
- Has access to computer or tablet and internet.
Key exclusion criteria (3 listed)
- Substantial health conditions (e.g., congestive heart failure, diagnosed dementia)
- Those anticipating further surgery (e.g. LLA revision) as identified by our study sites' physiatrists
- an inability to use a tablet (e.g. using hands for typing).
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 |
|---|---|---|
| SMARTSMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website. | Behavioural | SMART |
| ControlThe control group will receive a care booklet and weekly contacts for 6 weeks. | Behavioural | Control |
Primary outcome
TUG, Timed Up and Go test
Time frame: Ten weeks
The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.
ASCQ, the Ambulatory Self-Confidence Questionnaire
Time frame: Ten weeks
This questionnaire measures how confident you are in your ability to walk. Type of Administration: Self-Report. Response Scale: 0 (not confident at all) - 10 (extremely confident) Scoring: Participants' total score is derived by calculating a mean score Interpretation: Higher scores = higher level of self-confidence regarding ambulation
12 secondary outcomes
Self-Report Habit Index (SRHI)
Time frame: Ten weeks
Physical Activity Identity (PAI)
Time frame: Ten weeks
The Revised Amputee Body Image Scale (ABIS-R)
Time frame: Ten weeks
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Ten weeks
Self-Report Habit Index (SRH)
Time frame: Ten weeks
Activities Specific Balance Confidence (ABC) Scale
Time frame: Ten weeks
Residual limb pain, phantom pain, and non-painful phantom limb sensations
Time frame: Ten weeks
Short Musculoskeletal Function Assessment (SMFA)
Time frame: Ten weeks
Euro Quality of Life
Time frame: Ten weeks
Tenacious goal pursuit (TGP)
Time frame: Ten weeks
Action Planning Scale (AP)
Time frame: Ten weeks
Self-Management Assessment Scale (SMASc)
Time frame: Ten weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 36952517Esfandiari E, Miller WC, King S, Payne M, Mortenson WB, Underwood H, MacKay C, Ashe MC. Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss. PLoS One. 2023 Mar 23;18(3):e0278418. doi: 10.1371/journal.pone.0278418. eCollection 2023.
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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.
William C Miller, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART in people with Behavior and Amputation, run by University of British Columbia at 1 site in Canada.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William C Miller, PhD (+1 (604) 312-5245, bill.miller@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TUG, Timed Up and Go test (time frame: Ten weeks). The study lists 2 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 NCT04953364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.