FrailtyMAPS-BNCT05661058
Mapping Sedentary Behaviour in Older Adults Who Are Frail
An observational study of Frailty, run by Isabel Rodrigues at 1 site in Canada.
Trial summary
The purpose of this study is to map the context of sedentary behaviour among older adults who are frail. This study uses a unique combination of objective and self-report measures to assess context. Read more about this study
- Who is it for?
- Ages 60 to 105 years
- Conditions the study is for
- Frailty
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2023to 31 Dec 2023
- Phase
- Observational
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators aim to recruit 20 participants (65 years and older) living with frailty. The investigators will recruit males and females as gender may influence sedentary behaviour through socially constructed norms and roles and can be affected by differential access to resources, opportunities, and power. The investigators are collaborating with geriatricians at Hamilton Health Sciences to recruit participants. The physician will inform eligible participants of the study and provide participants with a number to contact the research assistant. The research assistant will speak with interested participants to confirm eligibility and enroll them in the study.
Who may be able to join
- 60 years and older;
- Categorizes as frail on the FRAIL scale ≥ 3 of 5;
- Lives in the Greater Hamilton Area (GHA)
- Speaks English or can attend with a translator.
Who cannot join
- Requires a wheelchair at least 55% of the awake day; needs to sit for long periods of time due to a medical condition; or not independently mobile (i.e., requires assistance from another individual to ambulate);
- Has travel plans or other commitments that means missing >30% of the rollout study period;
- Unable to follow two-step instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MAPping Sedentary Behaviour (MAPS-B) in Older Adults: A Mix-methods Longitudinal Study
The purpose of this study is to map the context of sedentary behaviour among older adults who are frail. This study uses a unique combination of objective and self-report measures to assess context. The investigators will also hold focus groups to understand which behaviours can be modified and conduct an analysis to understand which types of behaviours are associated with negative health outcomes.
Read the detailed description
Older adults who are frail are potentially the population that might benefit the most from a reduction in sedentary time as they are the most sedentary group and have the highest chronic disease burden. However, there is a dearth of evidence on effective interventions to reduce sedentary behaviour or total sedentary time in older adults, especially among individuals that are frail. Previous studies focused on reducing total sedentary time, while other studies aimed to increase physical activity levels with the assumption that sedentary time will be reallocated to physical activity. But, to date, such interventions have not been effective at reducing total sedentary behaviour time in older adults. Previous studies to reduce sedentary time and behaviour in older adults may not be effective because there is no research on the context of sedentary behaviour, about when and where to intervene, and which specific sedentary behaviours should be targeted. Almost all studies in older adults have assessed total sedentary time, which does not provide enough information to understand the context of sedentary behaviours. The main reason to understand context is because not all sedentary behaviours should be modified as some cognitively engaging sedentary behaviours (e.g., reading, socializing) appear to benefit health, while time spent in more passive activities may be detrimental. Therefore, the goal should not be to reduce total sedentary time, but rather identify sedentary behaviours that may be detrimental to the health of older adults who are frail.
Before we can develop an intervention to reduce sedentary behaviour among older adults, we must first assess the context of sedentary behaviour. Context is defined as the purpose of the sedentary behaviours, the location where the behaviours occur, the posture of the behaviours (e.g., lying, sitting), social context (e.g., alone or with others), and time of day the behaviours occur. The purpose of this study was to assess the feasibility of measuring the context of sedentary behaviour among older adults who are frail. We defined feasibility using recruitment, retention, and refusal rates (process) and the feasibility resource (i.e., can the tools capture context and are participants willing to use the tools). Our criteria for success were to recruit 20 participants within two months, 85% retention, and 20% refusal. Our secondary objectives are: 1) to determine the context of using objective and subjective measures to assess sedentary behaviours among older adults who are frail; 2) to identify which types of sedentary behaviours can be modified and when and where to intervene; and 3) to conduct an exploratory analysis to determine the association of certain types of sedentary behaviours on health-related outcomes.
- Conditions
- Frailty
- Keywords
- Sedentary behaviour, Frailty, Falls, Old adults
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total number of participants | As this is not an intervention study, the investigators only have one group which the investigators will follow at two-time points to map the context of sedentary behaviour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility process and resources
The purpose of this study was to assess the feasibility of measuring the context of sedentary behaviour among older adults who are frail. We defined feasibility using recruitment, retention, and refusal rates (process feasibility) and the feasibility resource (i.e., can the tools capture context and are participants willing to use the tools). Our criteria for success for process feasibility were to recruit 20 participants within two-months with 85% retention by end of study, and a 20% refusal rate.
Measured: Two months
Secondary outcomes (10)
Focus group (Winter)
The investigators will hold focus groups in groups of 5 participants or less after the winter collection periods to mitigate recall bias. The investigators will use semi-structured interviews to guide the focus group. Transcripts will be transcribed verbatim and analyzed in NVivo using codebook reliability thematic analysis
Measured: 1 day
Regression analysis (Winter)
The investigators will conduct an exploratory analysis of secondary outcomes using multiple linear regression in SPSS Statistics version 27 (IBM Corp, Armonk, New York, USA). The independent variable will be the most common sequences of sedentary behaviour during the Winter period, and the dependent variable will be the secondary health outcomes (e.g., frailty level, cognitive status). The covariates will include variables from PROGRESS (i.e., age and sex).
Measured: 7 consecutive days
Focus group (Spring)
The investigators will hold focus groups in groups of 5 participants or less after the spring collection periods to mitigate recall bias. The investigators will use semi-structured interviews to guide the focus group. Transcripts will be transcribed verbatim and analyzed in NVivo using codebook reliability thematic analysis
Measured: 1 day
Regression analysis (Spring)
The investigators will conduct an exploratory analysis of secondary outcomes using multiple linear regression in SPSS Statistics version 27 (IBM Corp, Armonk, New York, USA). The independent variable will be the most common sequences of sedentary behaviour during the Spring period, and the dependent variable will be the secondary health outcomes (e.g., frailty level, cognitive status). The covariates will include variables from PROGRESS (i.e., age and sex).
Measured: 3 consecutive days (2 weekdays and 1 weekend)
Context of sedentary behaviour (Winter)
Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals.
Measured: Weekday #1
Context of sedentary behaviour (Winter)
Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals.
Measured: Weekday #2
Context of sedentary behaviour (Winter)
Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals.
Measured: Weekend #1
Context of sedentary behaviour (Spring)
Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals.
Measured: Weekday #1
Context of sedentary behaviour (Spring)
Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals.
Measured: Weekday #2
Context of sedentary behaviour (Spring)
Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals.
Measured: Weekend #1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start13 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabel Rodrigues
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor-investigator, Isabel Rodrigues, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661058
- Sponsor's protocol ID
- MAPSB
- Acronym
- MAPS-B
- Status last verified
- Apr 2023
- First submitted
- 6 Dec 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walston J, Hadley EC, Ferrucci L, Guralnik JM, Newman AB, Studenski SA, Ershler WB, Harris T, Fried LP. Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. J Am Geriatr Soc. 2006 Jun;54(6):991-1001. doi: 10.1111/j.1532-5415.2006.00745.x.
PubMed 16776798Abellan van Kan G, Rolland YM, Morley JE, Vellas B. Frailty: toward a clinical definition. J Am Med Dir Assoc. 2008 Feb;9(2):71-2. doi: 10.1016/j.jamda.2007.11.005. No abstract available.
PubMed 18261696Bunt S, Steverink N, Olthof J, van der Schans CP, Hobbelen JSM. Social frailty in older adults: a scoping review. Eur J Ageing. 2017 Jan 31;14(3):323-334. doi: 10.1007/s10433-017-0414-7. eCollection 2017 Sep.
PubMed 28936141Gale CR, Westbury L, Cooper C. Social isolation and loneliness as risk factors for the progression of frailty: the English Longitudinal Study of Ageing. Age Ageing. 2018 May 1;47(3):392-397. doi: 10.1093/ageing/afx188.
PubMed 29309502Petrusevski C, Choo S, Wilson M, MacDermid J, Richardson J. Interventions to address sedentary behaviour for older adults: a scoping review. Disabil Rehabil. 2021 Oct;43(21):3090-3101. doi: 10.1080/09638288.2020.1725156. Epub 2020 Feb 14.
PubMed 32058808Chastin S, Gardiner PA, Harvey JA, Leask CF, Jerez-Roig J, Rosenberg D, Ashe MC, Helbostad JL, Skelton DA. Interventions for reducing sedentary behaviour in community-dwelling older adults. Cochrane Database Syst Rev. 2021 Jun 25;6(6):CD012784. doi: 10.1002/14651858.CD012784.pub2.
PubMed 34169503Owen N, Healy GN, Matthews CE, Dunstan DW. Too much sitting: the population health science of sedentary behavior. Exerc Sport Sci Rev. 2010 Jul;38(3):105-13. doi: 10.1097/JES.0b013e3181e373a2.
PubMed 20577058Blodgett J, Theou O, Kirkland S, Andreou P, Rockwood K. The association between sedentary behaviour, moderate-vigorous physical activity and frailty in NHANES cohorts. Maturitas. 2015 Feb;80(2):187-91. doi: 10.1016/j.maturitas.2014.11.010. Epub 2014 Nov 25.
PubMed 25542406Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sports Exerc. 2009 May;41(5):998-1005. doi: 10.1249/MSS.0b013e3181930355.
PubMed 19346988Rodrigues IB, Kalra M, Zheng R, Rabinovich A, Ioannidis G, Kobsar D, Bray SR, Adachi JD, Fang Q, Papaioannou A. Mapping context of sedentary behaviour in older adults who are prefrail and frail: an analysis of secondary outcomes from a longitudinal study (MAPS-B). BMJ Open. 2024 Nov 27;14(11):e084610. doi: 10.1136/bmjopen-2024-084610.
PubMed 39609010Rodrigues IB, Tariq S, Kouroukis A, Swance R, Adachi J, Bray S, Fang Q, Ioannidis G, Kobsar D, Rabinovich A, Papaioannou A, Zheng R. Mapping sedentary behaviour (MAPS-B) in winter and spring using wearable sensors, indoor positioning systems, and diaries in older adults who are pre-frail and frail: A feasibility longitudinal study. PLoS One. 2024 May 16;19(5):e0290197. doi: 10.1371/journal.pone.0290197. eCollection 2024.
PubMed 38753692
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAPping Sedentary Behaviour (MAPS-B) in Older Adults: A Mix-methods Longitudinal Study
- ClinicalTrials.gov ID
- NCT05661058
- Acronym / sponsor ID
- MAPS-B / MAPSB
- Conditions
- Frailty
- Keywords
- Sedentary behaviour, Frailty, Falls, Old adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Isabel RodriguesUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Dec 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.
The purpose of this study is to map the context of sedentary behaviour among older adults who are frail. This study uses a unique combination of objective and self-report measures to assess context. The investigators will also hold focus groups to understand which behaviours can be modified and conduct an analysis to understand which types of behaviours are associated with negative health outcomes.
Detailed description
Older adults who are frail are potentially the population that might benefit the most from a reduction in sedentary time as they are the most sedentary group and have the highest chronic disease burden. However, there is a dearth of evidence on effective interventions to reduce sedentary behaviour or total sedentary time in older adults, especially among individuals that are frail. Previous studies focused on reducing total sedentary time, while other studies aimed to increase physical activity levels with the assumption that sedentary time will be reallocated to physical activity. But, to date, such interventions have not been effective at reducing total sedentary behaviour time in older adults. Previous studies to reduce sedentary time and behaviour in older adults may not be effective because there is no research on the context of sedentary behaviour, about when and where to intervene, and which specific sedentary behaviours should be targeted. Almost all studies in older adults have assessed total sedentary time, which does not provide enough information to understand the context of sedentary behaviours. The main reason to understand context is because not all sedentary behaviours should be modified as some cognitively engaging sedentary behaviours (e.g., reading, socializing) appear to benefit health, while time spent in more passive activities may be detrimental. Therefore, the goal should not be to reduce total sedentary time, but rather identify sedentary behaviours that may be detrimental to the health of older adults who are frail.
Before we can develop an intervention to reduce sedentary behaviour among older adults, we must first assess the context of sedentary behaviour. Context is defined as the purpose of the sedentary behaviours, the location where the behaviours occur, the posture of the behaviours (e.g., lying, sitting), social context (e.g., alone or with others), and time of day the behaviours occur. The purpose of this study was to assess the feasibility of measuring the context of sedentary behaviour among older adults who are frail. We defined feasibility using recruitment, retention, and refusal rates (process) and the feasibility resource (i.e., can the tools capture context and are participants willing to use the tools). Our criteria for success were to recruit 20 participants within two months, 85% retention, and 20% refusal. Our secondary objectives are: 1) to determine the context of using objective and subjective measures to assess sedentary behaviours among older adults who are frail; 2) to identify which types of sedentary behaviours can be modified and when and where to intervene; and 3) to conduct an exploratory analysis to determine the association of certain types of sedentary behaviours on health-related outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total number of participants | – | –As this is not an intervention study, the investigators only have one group which the investigators will follow at two-time points to map the context of sedentary behaviour. |
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to recruit 20 participants (65 years and older) living with frailty. The investigators will recruit males and females as gender may influence sedentary behaviour through socially constructed norms and roles and can be affected by differential access to resources, opportunities, and power. The investigators are collaborating with geriatricians at Hamilton Health Sciences to recruit participants. The physician will inform eligible participants of the study and provide participants with a number to contact the research assistant. The research assistant will speak with interested participants to confirm eligibility and enroll them in the study.
Key inclusion criteria (4 listed)
- 60 years and older;
- Categorizes as frail on the FRAIL scale ≥ 3 of 5;
- Lives in the Greater Hamilton Area (GHA)
- Speaks English or can attend with a translator.
Key exclusion criteria (3 listed)
- Requires a wheelchair at least 55% of the awake day; needs to sit for long periods of time due to a medical condition; or not independently mobile (i.e., requires assistance from another individual to ambulate);
- Has travel plans or other commitments that means missing >30% of the rollout study period;
- Unable to follow two-step instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility process and resources
Time frame: Two months
The purpose of this study was to assess the feasibility of measuring the context of sedentary behaviour among older adults who are frail. We defined feasibility using recruitment, retention, and refusal rates (process feasibility) and the feasibility resource (i.e., can the tools capture context and are participants willing to use the tools). Our criteria for success for process feasibility were to recruit 20 participants within two-months with 85% retention by end of study, and a 20% refusal rate.
10 secondary outcomes
Focus group (Winter)
Time frame: 1 day
Regression analysis (Winter)
Time frame: 7 consecutive days
Focus group (Spring)
Time frame: 1 day
Regression analysis (Spring)
Time frame: 3 consecutive days (2 weekdays and 1 weekend)
Context of sedentary behaviour (Winter)
Time frame: Weekday #1
Context of sedentary behaviour (Winter)
Time frame: Weekday #2
Context of sedentary behaviour (Winter)
Time frame: Weekend #1
Context of sedentary behaviour (Spring)
Time frame: Weekday #1
Context of sedentary behaviour (Spring)
Time frame: Weekday #2
Context of sedentary behaviour (Spring)
Time frame: Weekend #1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Results publication: PubMed 16776798Walston J, Hadley EC, Ferrucci L, Guralnik JM, Newman AB, Studenski SA, Ershler WB, Harris T, Fried LP. Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. J Am Geriatr Soc. 2006 Jun;54(6):991-1001. doi: 10.1111/j.1532-5415.2006.00745.x.
- Results publication: PubMed 18261696Abellan van Kan G, Rolland YM, Morley JE, Vellas B. Frailty: toward a clinical definition. J Am Med Dir Assoc. 2008 Feb;9(2):71-2. doi: 10.1016/j.jamda.2007.11.005. No abstract available.
- Results publication: PubMed 28936141Bunt S, Steverink N, Olthof J, van der Schans CP, Hobbelen JSM. Social frailty in older adults: a scoping review. Eur J Ageing. 2017 Jan 31;14(3):323-334. doi: 10.1007/s10433-017-0414-7. eCollection 2017 Sep.
- Results publication: PubMed 29309502Gale CR, Westbury L, Cooper C. Social isolation and loneliness as risk factors for the progression of frailty: the English Longitudinal Study of Ageing. Age Ageing. 2018 May 1;47(3):392-397. doi: 10.1093/ageing/afx188.
- Results publication: PubMed 32058808Petrusevski C, Choo S, Wilson M, MacDermid J, Richardson J. Interventions to address sedentary behaviour for older adults: a scoping review. Disabil Rehabil. 2021 Oct;43(21):3090-3101. doi: 10.1080/09638288.2020.1725156. Epub 2020 Feb 14.
- Results publication: PubMed 34169503Chastin S, Gardiner PA, Harvey JA, Leask CF, Jerez-Roig J, Rosenberg D, Ashe MC, Helbostad JL, Skelton DA. Interventions for reducing sedentary behaviour in community-dwelling older adults. Cochrane Database Syst Rev. 2021 Jun 25;6(6):CD012784. doi: 10.1002/14651858.CD012784.pub2.
- Results publication: PubMed 20577058Owen N, Healy GN, Matthews CE, Dunstan DW. Too much sitting: the population health science of sedentary behavior. Exerc Sport Sci Rev. 2010 Jul;38(3):105-13. doi: 10.1097/JES.0b013e3181e373a2.
- Results publication: PubMed 25542406Blodgett J, Theou O, Kirkland S, Andreou P, Rockwood K. The association between sedentary behaviour, moderate-vigorous physical activity and frailty in NHANES cohorts. Maturitas. 2015 Feb;80(2):187-91. doi: 10.1016/j.maturitas.2014.11.010. Epub 2014 Nov 25.
- Results publication: PubMed 19346988Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sports Exerc. 2009 May;41(5):998-1005. doi: 10.1249/MSS.0b013e3181930355.
- Derived from this study: PubMed 39609010Rodrigues IB, Kalra M, Zheng R, Rabinovich A, Ioannidis G, Kobsar D, Bray SR, Adachi JD, Fang Q, Papaioannou A. Mapping context of sedentary behaviour in older adults who are prefrail and frail: an analysis of secondary outcomes from a longitudinal study (MAPS-B). BMJ Open. 2024 Nov 27;14(11):e084610. doi: 10.1136/bmjopen-2024-084610.
- Derived from this study: PubMed 38753692Rodrigues IB, Tariq S, Kouroukis A, Swance R, Adachi J, Bray S, Fang Q, Ioannidis G, Kobsar D, Rabinovich A, Papaioannou A, Zheng R. Mapping sedentary behaviour (MAPS-B) in winter and spring using wearable sensors, indoor positioning systems, and diaries in older adults who are pre-frail and frail: A feasibility longitudinal study. PLoS One. 2024 May 16;19(5):e0290197. doi: 10.1371/journal.pone.0290197. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Isabel Rodrigues 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 4 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 4 Apr 2023. 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?
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?
Feasibility process and resources (time frame: Two months). 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 NCT05661058, which also lists 11 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 Apr 2023.