InflammationNCT05881122
Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability
A study testing Mad Dog Dietary Consultation in people with Inflammation and Spinal Cord Injuries, run by Brock University at 1 site in Canada.
Trial summary
This study investigated the effects of a 2-part dietary consultation on adherence to an anti-inflammatory diet in individuals with neuromuscular disability. The effects on self-efficacy for adhering to the diet as well as neuropathic pain and depression one month post-consult were also determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Spinal Cord Injuries, Multiple Sclerosis
- What is being tested?
- Mad Dog Dietary Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 30 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for this study, participants were required to be over 18 years of age, fluent in English and at least one year removed from either SCI or neurological diagnosis. All participants but one (who had muscular dystrophy) had either spinal cord injury (SCI) or multiple sclerosis (MS). Participants with SCI could have any level or severity of injury while participants with MS could have had any type of MS.
Who cannot join
- Younger than 18
- Not fluent in English
- No SCI or diagnosis of MS or muscular dystrophy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an Anti-inflammatory Dietary Consultation on Self-efficacy, Adherence and Selected Health Outcomes: A Randomized Control Trial
This study investigated the effects of a 2-part dietary consultation on adherence to an anti-inflammatory diet in individuals with neuromuscular disability. The effects on self-efficacy for adhering to the diet as well as neuropathic pain and depression one month post-consult were also determined.
Read the detailed description
This study investigated the effects of a 2-part dietary consultation (the Mad Dog consult) on adherence to an anti-inflammatory diet (the Mad Dog diet) in individuals (N=11) with spinal cord injury, multiple sclerosis and muscular dystrophy. participants were randomly allocated into either the intervention group (n=7) or the control group (n=4).
The Mad Dog consultation was delivered in two parts over consecutive days. Part I entailed an accompanied trip to the participant's preferred grocery store in order to show the participant where selected foods could be found, how to read nutrition labels so that acceptable substitutions to the Mad Dog ingredients could be made, and how to shop for value when choices are presented. Part II of the consultation occurred in the participant's home and focused on meal preparation and kitchen accessibility, as well as a brief overview regarding the negative consequences of chronic inflammation, and the positive effects of adopting an anti-inflammatory diet. Accordingly, the researchers traveled to the participant's home and prepared two sample dinner meals for the participant in an interactive and instructional format. The researchers also brought selected pieces of accessible cooking equipment (designed for use in those with reduced hand function) which were demonstrated during the meal preparation. Participants were not given the equipment to keep, but they were instructed where to buy the equipment online if they found it beneficial. Questions and discussion were highly encouraged throughout the consultation and materials were left with the participants allowing them to easily review and reference information that was covered during the meeting. Specifically, participants were given a booklet with 28 compliant recipes, additional snack ideas and shopping tips along with a brochure summarizing the consult. The combined length of the consult was approximately 90-120 minutes.
Lastly, the Mad Dog consultation also included a virtual group, where participants could share and discuss anti-inflammatory recipes (that may complement the recipes in the Mad Dog diet) and engage in social support. Researchers were part of the group to oversee discussion but did not participate.
The control group only received the Mad Dog diet recipes, but did not take part in the consultation.
Adherence to the Mad Dog diet was determined by 7-day food logs before the intervention and at one month post-intervention. Task and barrier self-efficacy were determined by questionnaire at baseline (immediately after viewing the Mad Dog Diet), immediately after the consultation (in the intervention group only ) and at one month post-intervention (in both groups). Neuropathic pain and depression were determined by the Neuropathic Pain Questionnaire and the Centre for Epidemiological Studies Depression (CES-D) questionnaire at baseline and at one month post-intervention (in both groups).
- Being tested
- Mad Dog Dietary Consultation
- Medical subject headings
- Inflammation, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophies, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mad Dog Dietary ConsultationBehavioural
The Mad Dog consultation was delivered in two parts over consecutive days. Part I entailed an accompanied trip to the participant's preferred grocery store to show the participant where selected foods could be found, how to read nutrition labels so that acceptable substitutions to the Mad Dog ingredients could be made, and how to shop for value when choices are presented. Part II of the consultation occurred in the participant's home and focused on meal preparation and kitchen accessibility, as well as a brief overview regarding the negative consequences of chronic inflammation, and the positive effects of adopting an anti-inflammatory diet. Questions and discussion were highly encouraged throughout the consultation and materials were left with the participants allowing them to easily review and reference information that was covered during the meeting. Specifically, participants were given 28 compliant recipes, additional snack ideas and shopping tips along with a consult summary.
| Study group | Role | What they receive |
|---|---|---|
| Mad Dog Dietary Consultation Intervention group | Experimental | The intervention group received recipes for an anti-inflammatory diet and the 2-part consultation. The consultation consisted of a home-visit that included cooking and accessible kitchen equipment demonstrations, and an accompanied trip to the grocery store. Receives: Behavioral: Mad Dog Dietary Consultation |
| Control group | No intervention | The controls received the recipes only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Custom-designed task self-efficacy questionnaire
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Measured: Baseline (for the intervention group and the control group)
Custom-designed task self-efficacy questionnaire
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Measured: Immediately post-intervention (in the intervention group only)
Custom-designed task self-efficacy questionnaire
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Measured: One month post-intervention (for the intervention group and the control group)
Custom-designed barrier self-efficacy questionnaire
Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 7-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Measured: Baseline (for the intervention group and the control group).
Custom-designed barrier self-efficacy questionnaire
Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 7-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Measured: Immediately post-intervention (in the intervention group only).
Custom-designed barrier self-efficacy questionnaire
Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 7-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Measured: One month post-intervention (for the intervention group and the control group)
Adherence to the anti-inflammatory diet
Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. Adherence rates are then determined by calculating [(servings allowed/total servings) * 100].
Measured: Baseline (for the intervention group and the control group)
Adherence to the anti-inflammatory diet
Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. These values are then combined to calculate each participant's adherence rate with the formula: [(number of servings eaten that were allowed/total servings eaten) x 100]. Adherence rate will be expressed as a percentage. For example, if the participant ate 50 servings of food over 7 days, with 45 of those servings allowed by the anti-inflammatory diet and 5 servings not allowed (cheats), then the adherence rate would be calculated as: Adherence = 45/50 x 100 Adherence = 90%
Measured: One month post-intervention (for the intervention group and the control group)
Secondary outcomes (4)
Neuropathic pain questionnaire (NPQ)
Neuropathic pain as determined by the Neuropathic Pain Questionnaire (NPQ). The questionnaire consists of 32 items pertaining to three unique categories including sensory items, affective items, and sensitivity items. Sensory items are those related to the specific type and severity of pain felt (e.g., degree of burning, stabbing, throbbing), affective items relate to how the pain affects the participant in daily life (e.g., how irritating is your usual pain?) and sensitivity items related to how various stimuli may act to increase pain (e.g., increased pain due to heat). Participants are asked to rate their pain for each item numerically on a scale from 0-100 whereby 0 indicated the complete absence of pain and 100 indicated the worst pain imaginable. Scores from each of the three categories are averaged. Thus, the minimum score for each category is 0 and the maximum score for each category is 100, which higher scores indicating worse pain.
Measured: Baseline (for the intervention group and the control group)
Neuropathic pain questionnaire (NPQ)
Neuropathic pain as determined by the Neuropathic Pain Questionnaire (NPQ). The questionnaire consists of 32 items pertaining to three unique categories including sensory items, affective items, and sensitivity items. Sensory items are those related to the specific type and severity of pain felt (e.g., degree of burning, stabbing, throbbing), affective items relate to how the pain affects the participant in daily life (e.g., how irritating is your usual pain?) and sensitivity items related to how various stimuli may act to increase pain (e.g., increased pain due to heat). Participants are asked to rate their pain for each item numerically on a scale from 0-100 whereby 0 indicated the complete absence of pain and 100 indicated the worst pain imaginable. Scores from each of the three categories are averaged. Thus, the minimum score for each category is 0 and the maximum score for each category is 100, which higher scores indicating worse pain.
Measured: One month post-intervention (for the intervention group and the control group)
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) This is a 20-item questionnaire that asks participants to rate their depressive symptoms over the last 7 days, and each item is scored from 0-3. The minimum score for the questionnaire 0 and the maximum score is 60, with higher scores indicating worse depressive symptomology. Any score above 15 is indicative of clinical depression, but should not be taken as a diagnosis by itself.
Measured: Baseline (for the intervention group and the control group)
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) This is a 20-item questionnaire that asks participants to rate their depressive symptoms over the last 7 days, and each item is scored from 0-3. The minimum score for the questionnaire 0 and the maximum score is 60, with higher scores indicating worse depressive symptomology. Any score above 15 is indicative of clinical depression, but should not be taken as a diagnosis by itself.
Measured: One month post-intervention (for the intervention group and the control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Nov 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ditor, Brock University
- Investigators
- David S Ditor, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881122
- Sponsor's protocol ID
- 21-054 - Ditor
- Status last verified
- May 2023
- First submitted
- 17 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available upon reasonable request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Anti-inflammatory Dietary Consultation on Self-efficacy, Adherence and Selected Health Outcomes: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05881122
- Acronym / sponsor ID
- 21-054 - Ditor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 31 May 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.
This study investigated the effects of a 2-part dietary consultation on adherence to an anti-inflammatory diet in individuals with neuromuscular disability. The effects on self-efficacy for adhering to the diet as well as neuropathic pain and depression one month post-consult were also determined.
Detailed description
This study investigated the effects of a 2-part dietary consultation (the Mad Dog consult) on adherence to an anti-inflammatory diet (the Mad Dog diet) in individuals (N=11) with spinal cord injury, multiple sclerosis and muscular dystrophy. participants were randomly allocated into either the intervention group (n=7) or the control group (n=4).
The Mad Dog consultation was delivered in two parts over consecutive days. Part I entailed an accompanied trip to the participant's preferred grocery store in order to show the participant where selected foods could be found, how to read nutrition labels so that acceptable substitutions to the Mad Dog ingredients could be made, and how to shop for value when choices are presented. Part II of the consultation occurred in the participant's home and focused on meal preparation and kitchen accessibility, as well as a brief overview regarding the negative consequences of chronic inflammation, and the positive effects of adopting an anti-inflammatory diet. Accordingly, the researchers traveled to the participant's home and prepared two sample dinner meals for the participant in an interactive and instructional format. The researchers also brought selected pieces of accessible cooking equipment (designed for use in those with reduced hand function) which were demonstrated during the meal preparation. Participants were not given the equipment to keep, but they were instructed where to buy the equipment online if they found it beneficial. Questions and discussion were highly encouraged throughout the consultation and materials were left with the participants allowing them to easily review and reference information that was covered during the meeting. Specifically, participants were given a booklet with 28 compliant recipes, additional snack ideas and shopping tips along with a brochure summarizing the consult. The combined length of the consult was approximately 90-120 minutes.
Lastly, the Mad Dog consultation also included a virtual group, where participants could share and discuss anti-inflammatory recipes (that may complement the recipes in the Mad Dog diet) and engage in social support. Researchers were part of the group to oversee discussion but did not participate.
The control group only received the Mad Dog diet recipes, but did not take part in the consultation.
Adherence to the Mad Dog diet was determined by 7-day food logs before the intervention and at one month post-intervention. Task and barrier self-efficacy were determined by questionnaire at baseline (immediately after viewing the Mad Dog Diet), immediately after the consultation (in the intervention group only ) and at one month post-intervention (in both groups). Neuropathic pain and depression were determined by the Neuropathic Pain Questionnaire and the Centre for Epidemiological Studies Depression (CES-D) questionnaire at baseline and at one month post-intervention (in both groups).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mad Dog Dietary Consultation Intervention group | Experimental | Behavioral: Mad Dog Dietary ConsultationThe intervention group received recipes for an anti-inflammatory diet and the 2-part consultation. The consultation consisted of a home-visit that included cooking and accessible kitchen equipment demonstrations, and an accompanied trip to the grocery store. |
| Control group | No intervention | –The controls received the recipes only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for this study, participants were required to be over 18 years of age, fluent in English and at least one year removed from either SCI or neurological diagnosis. All participants but one (who had muscular dystrophy) had either spinal cord injury (SCI) or multiple sclerosis (MS). Participants with SCI could have any level or severity of injury while participants with MS could have had any type of MS.
Key exclusion criteria (3 listed)
- Younger than 18
- Not fluent in English
- No SCI or diagnosis of MS or muscular dystrophy
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 |
|---|---|---|
| Mad Dog Dietary ConsultationThe Mad Dog consultation was delivered in two parts over consecutive days. Part I entailed an accompanied trip to the participant's preferred grocery store to show the participant where selected foods could be found, how to read nutrition labels so that acceptable substitutions to the Mad Dog ingredients could be made, and how to shop for value when choices are presented. Part II of the consultation occurred in the participant's home and focused on meal preparation and kitchen accessibility, as well as a brief overview regarding the negative consequences of chronic inflammation, and the positive effects of adopting an anti-inflammatory diet. Questions and discussion were highly encouraged throughout the consultation and materials were left with the participants allowing them to easily review and reference information that was covered during the meeting. Specifically, participants were given 28 compliant recipes, additional snack ideas and shopping tips along with a consult summary. | Behavioural | Mad Dog Dietary Consultation Intervention group |
Primary outcome
Custom-designed task self-efficacy questionnaire
Time frame: Baseline (for the intervention group and the control group)
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Custom-designed task self-efficacy questionnaire
Time frame: Immediately post-intervention (in the intervention group only)
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Custom-designed task self-efficacy questionnaire
Time frame: One month post-intervention (for the intervention group and the control group)
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Custom-designed barrier self-efficacy questionnaire
Time frame: Baseline (for the intervention group and the control group).
Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 7-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Custom-designed barrier self-efficacy questionnaire
Time frame: Immediately post-intervention (in the intervention group only).
Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 7-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Custom-designed barrier self-efficacy questionnaire
Time frame: One month post-intervention (for the intervention group and the control group)
Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 7-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Adherence to the anti-inflammatory diet
Time frame: Baseline (for the intervention group and the control group)
Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. Adherence rates are then determined by calculating [(servings allowed/total servings) * 100].
Adherence to the anti-inflammatory diet
Time frame: One month post-intervention (for the intervention group and the control group)
Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. These values are then combined to calculate each participant's adherence rate with the formula: [(number of servings eaten that were allowed/total servings eaten) x 100]. Adherence rate will be expressed as a percentage. For example, if the participant ate 50 servings of food over 7 days, with 45 of those servings allowed by the anti-inflammatory diet and 5 servings not allowed (cheats), then the adherence rate would be calculated as: Adherence = 45/50 x 100 Adherence = 90%
4 secondary outcomes
Neuropathic pain questionnaire (NPQ)
Time frame: Baseline (for the intervention group and the control group)
Neuropathic pain questionnaire (NPQ)
Time frame: One month post-intervention (for the intervention group and the control group)
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
Time frame: Baseline (for the intervention group and the control group)
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
Time frame: One month post-intervention (for the intervention group and the control group)
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 31 May 2023.
- Individual participant dataSharing planned: No. Available upon reasonable request to the Principal Investigator
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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.
David S Ditor, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mad Dog Dietary Consultation in people with Inflammation and Spinal Cord Injuries, run by Brock University 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 1 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: finished, as of the sponsor's last update on 31 May 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?
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?
Custom-designed task self-efficacy questionnaire (time frame: Baseline (for the intervention group and the control group)). 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 31 May 2023.