Crohn DiseaseLYFEMDNCT04653259
Digital Nutrition Therapy for Patients With IBD
A study testing LYFE MD app in people with Crohn Disease and Ulcerative Colitis, run by University of Calgary at 1 site in Canada.
Trial summary
Background: Alberta's Center of Excellence for Nutrition in Digestive Diseases (Ascend) is dedicated to generating new discoveries regarding the link between nutrition and digestive diseases and mobilizing existing research to change the way physicians treat conditions such as inflammatory bowel disease, cirrhosis and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- LYFE MD app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2021to 15 Oct 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Patients with ileal, ileo-colonic, or colonic luminal CD and UC in clinical remission (Harvey Bradshaw Index <5 or Partial Mayo Score <3) will be invited to participate.
- Ability to provide informed consent
- Have smart phones to use the app
Who cannot join
- Patients more than 80 years old.
- Patients will be excluded if they are known to have upper GI Crohn's disease, fistulizing phenotype, > 1 small bowel resection, colectomy, or any psychiatric or neurocognitive comorbidity that would limit compliance.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
TRW building, Foothills, University of Calgary
Calgary, Alberta, T2N 4Z6
Maitreyi Raman, MD, 403-592-5020, mkothand@ucalgary.ca
Lorian Taylor, PhD, RD, 403-952-5154, lorian.taylor@ucalgary.ca
About this study
Official title: Using the LyfeMD Application for Effective Maintenance of Remission and Improved Quality of Life in Crohn's Disease and Ulcerative Colitis: A Randomized Controlled Trial
Background: Alberta's Center of Excellence for Nutrition in Digestive Diseases (Ascend) is dedicated to generating new discoveries regarding the link between nutrition and digestive diseases and mobilizing existing research to change the way physicians treat conditions such as inflammatory bowel disease, cirrhosis and intestinal failure. Ascend is a collaboration of excellence within the Department of Medicine, Division of Gastroenterology at both the University of Calgary and University of Alberta. Dr. Raman, PI, is the Director of Ascend.
One of Ascend's primary initiatives is the development of a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). Dr. Raman and her team have developed an app called LyfeMD, by translating leading scientific research into a practical and engaging digital format. LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research led by Dr. Raman's team, and exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free.
In addition to delivering personalized and interactive support, the app uses behavior science to help patients change their habits, improve their health and reduce the burden IBD places on their lives. With proprietary research and a team made up of internationally recognized leaders in the gastrointestinal field, LyfeMD is poised to be the trusted digital health solution for people living with IBD.
Read the detailed description
Study Objectives:
- To identify if the LyfeMD app improves diet quality, perceived stress, depression, anxiety, well-being, quality of life, sleep, and physical activity minutes.
- To identify if the LyfeMD app helps improve intestinal inflammation measured by fecal calprotectin in CD and UC patients in clinical remission.
Methods:
This 1-year study at the University of Calgary (n=44) will have a RCT study design. Participants will be randomly allocated to receive the intervention LyfeMD mobile application (INT) for 12-weeks or conventional management (CM) from the IBD clinic at the Foothills hospital.
Intervention Group(INT): The INT group (n=22) will meet with the health coach over the phone or video chat. The health coach will orient the participant to the LyfeMD app, answer technology related questions and ensure that the participant has received a nutrition plan in the app. Participants will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. Participants will set goals in each area that they are interested in implementing.
The health coach will then follow-up by phone, video chat or email 2 weeks after the initial meeting, then monthly with the participants for 2 more months (total of 4 meetings). The health coach will use the following schedule to discuss app related content: First visit nutrition content; second visit behaviour change tools; third visit Yoga, meditation and breathing plans, and; the fourth visit the physical activity plans. The health coach will also be available to answer questions when required using email. Goal attainment will be collected weekly within the app.
Conventional Management (CM): The CM group (n=22) will receive conventional care as well as a similar health coaching schedule as the intervention group. The health coach will meet the patrticipants over the phone or video chat to outline their role over the next 3 months and to provide general nutrition guidelines using Canada's Food Guide and Alberta Health Services online resources. The health coach will then follow-up participant by phone, video chat or email 2 weeks after the initial meeting, then monthly for 2 more months (total of 4 meetings). The health coach session topics will be same as the intervention group. For example, the second visit will provide online resources from Alberta Health Services focused on promoting behaviour change, the third visit will orient the patient to Alberta Health Services focused online stress management tools and the final visit will share online versions of the Canadian guidelines for physical activity and sedentary time.
The health coach will be available to answer questions when required using email.
Following completion of the 12-week study, participants in the control group will receive complimentary access to the LyfeMD app for 12-weeks.
Both groups will meet with the study coordinator face to face at the start and end of the study (13th week). At this time, participants will be given all the study materials they need.
Relationship to Pfizer:
From a Pfizer perspective, the investigators recognize that Inflectra is growing in market share. The LyfeMD program will be used together, in a complementary way alongside biologic therapy. The recent diet study led by the principle investigator indicates that the customized diet using anti-inflammatory principles will induce remission in 6 weeks and maintain remission in patients with CD. The investigators would expect that combining diet therapy with biologics would bolster the effect of the biologic and longevity of remission. With the wellness additions (physical activity and yoga/meditation programs), the investigators predict patients will lead happier lives.
Investigators believe that the LyfeMD app will fill a current gap in the market. The availability of Registered Dietitian (RD), Exercise Physiologists, and Certified yoga and meditation instructors in AB/Canada is inadequate to provide care to every patient with IBD in a convenient and personalized way.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- LYFE MD app
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYFE MD appOther
LyfeMD app is a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research, exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free.
In addition to delivering personalized and interactive support, the app uses behaviour science to help patients change their habits, improve their health and reduce the burden IBD places on their lives.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The INT group will meet with their health coach over the phone or video chat. The health coach will orient them to the LyfeMD, app and ensure the participant has received a nutrition plan in the app. They will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. They will set goals in each area they are interested in implementing. The health coach will then follow-up by phone, video or email 2 weeks after the initial meeting, then monthly with the patient for 2 more months (total of 4 meetings). The health coach will use the following schedule to discuss app related content: First visit nutrition content; second visit behaviour change tools; third visit Yoga, meditation and breathing plans, and; the fourth visit the physical activity plans. The health coach will also be available to answer questions when required using email. Goal attainment will be collected weekly within the app. Receives: Other: LYFE MD app |
| Conventional Management Group | No intervention | The CM group (n=22) will receive conventional care as well as a similar health coaching schedule as the intervention group. The health coach will meet the patient over the phone or video chat to outline their role over the next 3 months and to provide general nutrition guidelines using Canada's Food Guide and Alberta Health Services online resources. The health coach will then follow-up by phone, video chat or email 2 weeks after the initial meeting, then monthly with the patient for 2 more months (total of 4 meetings). The health coach session topics will be the same as the intervention group. For example, the second visit will provide online resources from Alberta Health Services focused on promoting behaviour change, the third visit will orient the patient to Alberta Health Services focused online stress management tools and the final visit will share online versions of the Canadian guidelines for physical activity and sedentary time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-form 12-items (SF-12): Change is being assessed.
Assess quality of life
Measured: Baseline and 12 week
Perceived stress score 10-item measure (PSS-10): Change is being assessed.
measure the stress level
Measured: Baseline and 12 week
Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed.
Measure the sleep quality
Measured: Baseline and 12 week
Godin, a validated 4-item tool: Change is being assessed.
Physical activity minutes will be measured, to estimate weekly physical activity minutes from both moderate and vigorous leisure-time activity.
Measured: Baseline and 12 week
24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed.
To measure the well being and positive aspect
Measured: Baseline and 12 week
Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed.
To measure the anxiety severity
Measured: Baseline and 12 week
Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed.
To measure depression
Measured: Baseline and 12 week
Behaviour compliance: Change is being assessed.
This will be measured by scoring how many goals the patients reports successfully tracking each week in the three different content areas. This is all done inside of the app.
Measured: Once every week starting from date of randomization upto week 12
Secondary outcomes (4)
24 hour ASA food recalls: Change is being assessed.
Assess diet quality
Measured: Base line and 12 week
Fecal calprotectin: Change is being assessed.
FCP is a test used to detect inflammation in the colon and is associated with disease activity and severity.
Measured: Baseline and 12 week
Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed.
HBI is a validated, non-invasive measure of disease activity captured through a symptom questionnaire and is a surrogate to endoscopic assessment to determine disease severity. HBI minimum value is "0" and maximum no limit. HBI < 5 is used in this study to indicate clinical remission. HBI> 16 means severe disease activity. Higher scores means worse outcomes. Based on experience with past recruitment for clinical trials, endoscopic assessment is not feasible due to access and patient acceptance.
Measured: Baseline and 12 week
Partial-Mayo score for ulcerative colitis: Change is being assessed.
Partial Mayo Score (PMS), is a bedside measure of disease activity captured through a symptom questionnaire. It uses the three non-invasive components of the full Mayo Score (stool frequency, rectal bleeding and Physician's global assessment). This excludes the score for the endoscopic findings, therefore the maximum score is reduced from 12 to 9 points (1,2).
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start15 May 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Maitreyi Raman, University of Calgary
- Investigators
- Maitreyi Raman, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653259
- Sponsor's protocol ID
- REB20-1534
- Acronym
- LYFEMD
- Status last verified
- Sep 2021
- First submitted
- 25 Nov 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the LyfeMD Application for Effective Maintenance of Remission and Improved Quality of Life in Crohn's Disease and Ulcerative Colitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04653259
- Acronym / sponsor ID
- LYFEMD / REB20-1534
- Conditions
- Crohn Disease, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 4 Dec 2020 (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.
Background: Alberta's Center of Excellence for Nutrition in Digestive Diseases (Ascend) is dedicated to generating new discoveries regarding the link between nutrition and digestive diseases and mobilizing existing research to change the way physicians treat conditions such as inflammatory bowel disease, cirrhosis and intestinal failure. Ascend is a collaboration of excellence within the Department of Medicine, Division of Gastroenterology at both the University of Calgary and University of Alberta. Dr. Raman, PI, is the Director of Ascend.
One of Ascend's primary initiatives is the development of a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). Dr. Raman and her team have developed an app called LyfeMD, by translating leading scientific research into a practical and engaging digital format. LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research led by Dr. Raman's team, and exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free.
In addition to delivering personalized and interactive support, the app uses behavior science to help patients change their habits, improve their health and reduce the burden IBD places on their lives. With proprietary research and a team made up of internationally recognized leaders in the gastrointestinal field, LyfeMD is poised to be the trusted digital health solution for people living with IBD.
Detailed description
Study Objectives:
- To identify if the LyfeMD app improves diet quality, perceived stress, depression, anxiety, well-being, quality of life, sleep, and physical activity minutes.
- To identify if the LyfeMD app helps improve intestinal inflammation measured by fecal calprotectin in CD and UC patients in clinical remission.
Methods:
This 1-year study at the University of Calgary (n=44) will have a RCT study design. Participants will be randomly allocated to receive the intervention LyfeMD mobile application (INT) for 12-weeks or conventional management (CM) from the IBD clinic at the Foothills hospital.
Intervention Group(INT): The INT group (n=22) will meet with the health coach over the phone or video chat. The health coach will orient the participant to the LyfeMD app, answer technology related questions and ensure that the participant has received a nutrition plan in the app. Participants will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. Participants will set goals in each area that they are interested in implementing.
The health coach will then follow-up by phone, video chat or email 2 weeks after the initial meeting, then monthly with the participants for 2 more months (total of 4 meetings). The health coach will use the following schedule to discuss app related content: First visit nutrition content; second visit behaviour change tools; third visit Yoga, meditation and breathing plans, and; the fourth visit the physical activity plans. The health coach will also be available to answer questions when required using email. Goal attainment will be collected weekly within the app.
Conventional Management (CM): The CM group (n=22) will receive conventional care as well as a similar health coaching schedule as the intervention group. The health coach will meet the patrticipants over the phone or video chat to outline their role over the next 3 months and to provide general nutrition guidelines using Canada's Food Guide and Alberta Health Services online resources. The health coach will then follow-up participant by phone, video chat or email 2 weeks after the initial meeting, then monthly for 2 more months (total of 4 meetings). The health coach session topics will be same as the intervention group. For example, the second visit will provide online resources from Alberta Health Services focused on promoting behaviour change, the third visit will orient the patient to Alberta Health Services focused online stress management tools and the final visit will share online versions of the Canadian guidelines for physical activity and sedentary time.
The health coach will be available to answer questions when required using email.
Following completion of the 12-week study, participants in the control group will receive complimentary access to the LyfeMD app for 12-weeks.
Both groups will meet with the study coordinator face to face at the start and end of the study (13th week). At this time, participants will be given all the study materials they need.
Relationship to Pfizer:
From a Pfizer perspective, the investigators recognize that Inflectra is growing in market share. The LyfeMD program will be used together, in a complementary way alongside biologic therapy. The recent diet study led by the principle investigator indicates that the customized diet using anti-inflammatory principles will induce remission in 6 weeks and maintain remission in patients with CD. The investigators would expect that combining diet therapy with biologics would bolster the effect of the biologic and longevity of remission. With the wellness additions (physical activity and yoga/meditation programs), the investigators predict patients will lead happier lives.
Investigators believe that the LyfeMD app will fill a current gap in the market. The availability of Registered Dietitian (RD), Exercise Physiologists, and Certified yoga and meditation instructors in AB/Canada is inadequate to provide care to every patient with IBD in a convenient and personalized way.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: LYFE MD appThe INT group will meet with their health coach over the phone or video chat. The health coach will orient them to the LyfeMD, app and ensure the participant has received a nutrition plan in the app. They will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. They will set goals in each area they are interested in implementing. The health coach will then follow-up by phone, video or email 2 weeks after the initial meeting, then monthly with the patient for 2 more months (total of 4 meetings). The health coach will use the following schedule to discuss app related content: First visit nutrition content; second visit behaviour change tools; third visit Yoga, meditation and breathing plans, and; the fourth visit the physical activity plans. The health coach will also be available to answer questions when required using email. Goal attainment will be collected weekly within the app. |
| Conventional Management Group | No intervention | –The CM group (n=22) will receive conventional care as well as a similar health coaching schedule as the intervention group. The health coach will meet the patient over the phone or video chat to outline their role over the next 3 months and to provide general nutrition guidelines using Canada's Food Guide and Alberta Health Services online resources. The health coach will then follow-up by phone, video chat or email 2 weeks after the initial meeting, then monthly with the patient for 2 more months (total of 4 meetings). The health coach session topics will be the same as the intervention group. For example, the second visit will provide online resources from Alberta Health Services focused on promoting behaviour change, the third visit will orient the patient to Alberta Health Services focused online stress management tools and the final visit will share online versions of the Canadian guidelines for physical activity and sedentary time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Patients with ileal, ileo-colonic, or colonic luminal CD and UC in clinical remission (Harvey Bradshaw Index <5 or Partial Mayo Score <3) will be invited to participate.
- Ability to provide informed consent
- Have smart phones to use the app
Key exclusion criteria (2 listed)
- Patients more than 80 years old.
- Patients will be excluded if they are known to have upper GI Crohn's disease, fistulizing phenotype, > 1 small bowel resection, colectomy, or any psychiatric or neurocognitive comorbidity that would limit compliance.
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 |
|---|---|---|
| LYFE MD appLyfeMD app is a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research, exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free. In addition to delivering personalized and interactive support, the app uses behaviour science to help patients change their habits, improve their health and reduce the burden IBD places on their lives. | Other | Intervention Group |
Primary outcome
Short-form 12-items (SF-12): Change is being assessed.
Time frame: Baseline and 12 week
Assess quality of life
Perceived stress score 10-item measure (PSS-10): Change is being assessed.
Time frame: Baseline and 12 week
measure the stress level
Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed.
Time frame: Baseline and 12 week
Measure the sleep quality
Godin, a validated 4-item tool: Change is being assessed.
Time frame: Baseline and 12 week
Physical activity minutes will be measured, to estimate weekly physical activity minutes from both moderate and vigorous leisure-time activity.
24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed.
Time frame: Baseline and 12 week
To measure the well being and positive aspect
Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed.
Time frame: Baseline and 12 week
To measure the anxiety severity
Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed.
Time frame: Baseline and 12 week
To measure depression
Behaviour compliance: Change is being assessed.
Time frame: Once every week starting from date of randomization upto week 12
This will be measured by scoring how many goals the patients reports successfully tracking each week in the three different content areas. This is all done inside of the app.
4 secondary outcomes
24 hour ASA food recalls: Change is being assessed.
Time frame: Base line and 12 week
Fecal calprotectin: Change is being assessed.
Time frame: Baseline and 12 week
Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed.
Time frame: Baseline and 12 week
Partial-Mayo score for ulcerative colitis: Change is being assessed.
Time frame: Baseline and 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers outside of the study team.
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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.
Maitreyi Raman, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYFE MD app in people with Crohn Disease and Ulcerative Colitis, run by University of Calgary 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 2 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 16 Sep 2021. 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 Maitreyi Raman, MD (403-592-5020, mkothand@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-form 12-items (SF-12): Change is being assessed. (time frame: Baseline and 12 week). The study lists 8 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 16 Sep 2021.