OsteoporosisMisterFItNCT05927623
Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men
A study testing Multifaceted Virtual Fracture Prevention Program in people with Osteoporosis and Osteoporotic Fractures, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites in Canada.
Trial summary
Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Osteoporosis, Osteoporotic Fractures, Osteoporosis, Age-Related
- What is being tested?
- Multifaceted Virtual Fracture Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesCanada
- Study dates
- 7 Feb 2023to 31 Mar 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Inability to communicate in English or French;
- No access to a mobile device, tablet, or computer with a camera;
- Clinical or symptomatic spine fracture in the last 4 months, or a lower/upper limb fracture in the last 2 months;
- Uncontrolled medical comorbidity including but not limited to congestive heart failure exacerbation in the last 12 months or COPD exacerbation in the last 3 months
- Currently doing or planning to start doing either: A) Resistance training exercises with a self-rated intensity of very hard (e.g., rated ≥ 8 on a scale from 0-10) for two or more times a week OR B) Exercises to improve balance for two or more times a week
- Unable to perform basic activities of daily living or severe cognitive impairment or terminal illness
- Presence of absolute exercise contraindications unless physician approval is obtained if contraindications are present
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Calgary
Calgary, Alberta
McMaster University
Hamilton, Ontario
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Centre Hospitalier Universitaire de Québec
Québec, Quebec
University Health Network
Toronto, Ontario
About this study
Official title: Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study
Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million.
Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment.
Read more
Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men.
Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change.
The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only.
Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.
Read the detailed description
The current proposal for this assessor-blind parallel group multicenter pilot RCT of 12 months duration is in line with published frameworks for pilot studies in preparation for RCTs. For the pilot study, the investigators will enroll participants irrespective of anti-osteoporosis medication use.
This pilot RCT will determine the following primary feasibility objectives which will be assessed at 12 months :
- Study recruitment rates: The study will be considered feasible if the investigators can recruit 12 participants per site within one year. Recruitment of 12 participants/site/year will translate to 360 participants with 10 sites over 3 years, which is the estimated sample size required for our future RCT with primary outcomes of physical function and fall rates, and secondary outcomes of bone strength.
- Study retention rates: The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment. This estimation is based on exercise RCTs where the attrition rate at 12 months ranged between 4% to 13% in community-based healthy men and up to 17% in frail older men.
- Adherence to the exercise and nutrition interventions: The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. Beneficial effects of in-person supervised exercise on physical function in older men and women have been shown with a mean exercise session adherence of 60% at 12 months, and with a mean exercise session adherence of 63% in older men at 18 months. The nutrition intervention will be considered feasible if participants attend 66% of the visits.
- Perceived usability of the telehealth platform application: via the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).
The investigators will also report exploratory analyses comparing the effect of the virtual intervention group to an attention control group. Exploratory outcomes will include the number of falls and fractures, changes in physical function (measured by lower extremity strength, gait speed, and balance), fall self-efficacy, quality of life and self-management behaviors in nutrition and exercise.
- Conditions
- Osteoporosis, Osteoporotic Fractures, Osteoporosis, Age-Related, Muscle Loss, Men, Aging
- Being tested
- Multifaceted Virtual Fracture Prevention Program, Attention Control
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures, Muscular Atrophy, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted Virtual Fracture Prevention ProgramBehavioural
- Personalized exercise prescription: Comprised of muscle strengthening and balance exercises to perform three times a week, delivered and monitored remotely via the MisterFit app, a branded version of the secure commercially available Wibbi app (wibbi.com) and monthly virtual exercise consultations.
- Virtual nutrition counseling from a registered dietitian in months 2, 4 and 6: to encourage participants to meet daily targets for calcium and vitamin D (preferably from diet), and protein intake to support muscle accretion and target weight maintenance
- Virtual interactive information sessions in month 4 and 8: to education participants on topics identified as important by the Misterfit patient partner advisory committee.
Attention ControlBehavioural
- Encouraged to meet the 24-Hour Movement Guidelines for adults aged 65 years or older (https://csepguidelines.ca) with telephone contacts at the same frequency that the Misterfit online group receives virtual exercise consultations
- Nutritional fact sheets: sent by e-mail at the same frequency that the Misterfit online group meets with the research dietitian.
- Educational fact sheets: sent by e-mail at the same frequency that the Misterfit Online group has virtual interactive information sessions
| Study group | Role | What they receive |
|---|---|---|
| Misterfit online group | Experimental | The Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education. Receives: Behavioral: Multifaceted Virtual Fracture Prevention Program |
| MisterFit offline group | Other | The Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment rates (feasibility objective)
The study will be considered feasible if the investigators can recruit 12 participants per site within one year
Measured: 12 months
Study retention rates (feasibility objective)
The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment
Measured: 12 months
Adherence to the exercise and nutrition interventions (feasibility objective)
The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. The nutrition intervention will be considered feasible if participants attend 66% of the visits.
Measured: 12 months
Perceived usability and satisfaction of the telehealth platform application (feasibility objective)
Measured using the the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).
Measured: 12 months
Secondary outcomes (16)
Change of health-related quality of life
Measured using the multi-dimensional, self-administered EuroQol five-dimension (EQ-5D-3L) questionnaire
Measured: 0, 6, and 12 months
Change in social isolation
Measured using the UCLA 3-Item Loneliness Scale questionnaire
Measured: 0, 6, and 12 months
Change in the action planning phase of behaviour
Measured using the Health Action Process Approach (HAPA) questionnaire
Measured: 6 and 12 months
Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake
Measured using the Osteoporosis Self-Efficacy Scale (OSES) questionnaire
Measured: 0, 6, and 12 months
Change in fear of falling in community-dwelling older adults
Measured using the seven-item self-administered Falls Efficacy Scale (FES) questionnaire
Measured: 0, 6, and 12 months
Change in physical activity
Measured using the Physical Activity Scale for the elderly (PASE) questionnaire
Measured: 0, 6, and 12 months
Change in total protein intake
Measured in grams using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 2, 6, and 12 months
Change in total calcium intake
Measured in mg using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 2, 6, and 12 months
Change in vitamin D intake
Measured in IU using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 2, 6, and 12 months
Change in functional leg muscle strength
Measured using the 30-second Chair stand test
Measured: 0 and 12 months
Change in gait speed
Measured using the 10-meter walk test
Measured: 0 and 12 months
Change in dynamic balance
Measured using the four-step square test
Measured: 0 and 12 months
Change in balance
Measured using the Short Form Berg Balance Scale (SF BBS-3P)
Measured: 0 and 12 months
Number of falls reported
Collected using falls calendar
Measured: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Healthcare utilization
Collected using healthcare utilization questionnaire
Measured: 0, 6 and 12 months
Reporting of safety outcomes (serious and non-serious adverse events)
Collected using Adverse Event Reporting
Measured: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start7 Feb 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessor-blind parallel group multicenter pilot RCT of 12 months duration.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Suzanne Morin, MD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927623
- Sponsor's protocol ID
- MP-37-2022-8396
- Acronym
- MisterFIt
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study
- ClinicalTrials.gov ID
- NCT05927623
- Acronym / sponsor ID
- MisterFIt / MP-37-2022-8396
- Conditions
- Osteoporosis, Osteoporotic Fractures, Osteoporosis, Age-Related, Muscle Loss, Men, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Jul 2023 (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.
Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million.
Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment.
Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men.
Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change.
The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only.
Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.
Detailed description
The current proposal for this assessor-blind parallel group multicenter pilot RCT of 12 months duration is in line with published frameworks for pilot studies in preparation for RCTs. For the pilot study, the investigators will enroll participants irrespective of anti-osteoporosis medication use.
This pilot RCT will determine the following primary feasibility objectives which will be assessed at 12 months :
- Study recruitment rates: The study will be considered feasible if the investigators can recruit 12 participants per site within one year. Recruitment of 12 participants/site/year will translate to 360 participants with 10 sites over 3 years, which is the estimated sample size required for our future RCT with primary outcomes of physical function and fall rates, and secondary outcomes of bone strength.
- Study retention rates: The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment. This estimation is based on exercise RCTs where the attrition rate at 12 months ranged between 4% to 13% in community-based healthy men and up to 17% in frail older men.
- Adherence to the exercise and nutrition interventions: The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. Beneficial effects of in-person supervised exercise on physical function in older men and women have been shown with a mean exercise session adherence of 60% at 12 months, and with a mean exercise session adherence of 63% in older men at 18 months. The nutrition intervention will be considered feasible if participants attend 66% of the visits.
- Perceived usability of the telehealth platform application: via the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).
The investigators will also report exploratory analyses comparing the effect of the virtual intervention group to an attention control group. Exploratory outcomes will include the number of falls and fractures, changes in physical function (measured by lower extremity strength, gait speed, and balance), fall self-efficacy, quality of life and self-management behaviors in nutrition and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Assessor-blind parallel group multicenter pilot RCT of 12 months duration.
| Arm | Type | Receives |
|---|---|---|
| Misterfit online group | Experimental | Behavioral: Multifaceted Virtual Fracture Prevention ProgramThe Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education. |
| MisterFit offline group | Other | Behavioral: Attention ControlThe Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Inability to communicate in English or French;
- No access to a mobile device, tablet, or computer with a camera;
- Clinical or symptomatic spine fracture in the last 4 months, or a lower/upper limb fracture in the last 2 months;
- Uncontrolled medical comorbidity including but not limited to congestive heart failure exacerbation in the last 12 months or COPD exacerbation in the last 3 months
- Currently doing or planning to start doing either: A) Resistance training exercises with a self-rated intensity of very hard (e.g., rated ≥ 8 on a scale from 0-10) for two or more times a week OR B) Exercises to improve balance for two or more times a week
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 |
|---|---|---|
| Multifaceted Virtual Fracture Prevention Program* Personalized exercise prescription: Comprised of muscle strengthening and balance exercises to perform three times a week, delivered and monitored remotely via the MisterFit app, a branded version of the secure commercially available Wibbi app (wibbi.com) and monthly virtual exercise consultations. * Virtual nutrition counseling from a registered dietitian in months 2, 4 and 6: to encourage participants to meet daily targets for calcium and vitamin D (preferably from diet), and protein intake to support muscle accretion and target weight maintenance * Virtual interactive information sessions in month 4 and 8: to education participants on topics identified as important by the Misterfit patient partner advisory committee. | Behavioural | Misterfit online group |
| Attention Control* Encouraged to meet the 24-Hour Movement Guidelines for adults aged 65 years or older (https://csepguidelines.ca) with telephone contacts at the same frequency that the Misterfit online group receives virtual exercise consultations * Nutritional fact sheets: sent by e-mail at the same frequency that the Misterfit online group meets with the research dietitian. * Educational fact sheets: sent by e-mail at the same frequency that the Misterfit Online group has virtual interactive information sessions | Behavioural | MisterFit offline group |
Primary outcome
Study recruitment rates (feasibility objective)
Time frame: 12 months
The study will be considered feasible if the investigators can recruit 12 participants per site within one year
Study retention rates (feasibility objective)
Time frame: 12 months
The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment
Adherence to the exercise and nutrition interventions (feasibility objective)
Time frame: 12 months
The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. The nutrition intervention will be considered feasible if participants attend 66% of the visits.
Perceived usability and satisfaction of the telehealth platform application (feasibility objective)
Time frame: 12 months
Measured using the the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).
16 secondary outcomes
Change of health-related quality of life
Time frame: 0, 6, and 12 months
Change in social isolation
Time frame: 0, 6, and 12 months
Change in the action planning phase of behaviour
Time frame: 6 and 12 months
Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake
Time frame: 0, 6, and 12 months
Change in fear of falling in community-dwelling older adults
Time frame: 0, 6, and 12 months
Change in physical activity
Time frame: 0, 6, and 12 months
Change in total protein intake
Time frame: 2, 6, and 12 months
Change in total calcium intake
Time frame: 2, 6, and 12 months
Change in vitamin D intake
Time frame: 2, 6, and 12 months
Change in functional leg muscle strength
Time frame: 0 and 12 months
Change in gait speed
Time frame: 0 and 12 months
Change in dynamic balance
Time frame: 0 and 12 months
Change in balance
Time frame: 0 and 12 months
Number of falls reported
Time frame: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Healthcare utilization
Time frame: 0, 6 and 12 months
Reporting of safety outcomes (serious and non-serious adverse events)
Time frame: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- 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. This study is not recruiting at the moment.
Suzanne Morin, MD principal investigator
Research Institute of the McGill University Health Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted Virtual Fracture Prevention Program in people with Osteoporosis and Osteoporotic Fractures, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites 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 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study recruitment rates (feasibility objective) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.