StrokeNCT05032638
Adherence in Upper Extremity Home-based Rehabilitation
A study testing Therapist guided training and Upper extremity (UE) Training in people with Stroke, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of the proposal is to determine the feasibility of implementing Ecological Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence for a 4-week self-initiated arm training protocol. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Therapist guided training and Upper extremity (UE) Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 24 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years old) diagnosed with stroke at least 6 months ago at the time of screening
- Living in the community
- Have presence of UE motor impairment on the affected side (Fugl-Meyer Assessment scores < 66)
- Availability of mobile technology (tablet or smartphone) with internet connection to use phone app and Zoom videochat)
- Be medically stable
- Able to provide written consent
Who cannot join
- Currently receiving active occupational or physical therapy for the treatment of the affected UE
- Presence of severe cognitive impairment (Mini Mental Status Exam <24)
- Self-reported moderate to severe pain of the affected UE with use
- Presence of unilateral spatial neglect (Star Cancellation Task scores < 44)
- Presence of neurological diagnosis other than stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Adherence in Upper Extremity Home-based Rehabilitation Through Motivational Interviewing and Ecological Momentary Assessment
The objective of the proposal is to determine the feasibility of implementing Ecological Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence for a 4-week self-initiated arm training protocol. A non-randomized feasibility study using a 4-week UE training protocol will be conducted in 15 individuals within the first 12 months post-stroke living in the community. EMA data will be collected using a mobile app to automate real-time collection of adherence data on a daily basis. MI will be used to produce self-generated training plans (training goals, training schedule), guided by the therapist before the start of training.
Read the detailed description
Using a mixed methods design, the study will collect quantitative data before, during, and after training. Qualitative data will be collected after the training period and analyzed to explain the quantitative findings in depth, within the context of everyday life. Study aim 1 is to evaluate the feasibility of using EMA to measure adherence and of applying the MI approach. Quantitative data will include four indicators of adherence and accuracy. Interview responses will be used as qualitative data to elucidate participants' acceptance of the MI approach and feedback on using the EMA app. Study aim 2 is to explore to what extent UE outcomes change after the 4-week self-initiated home-based rehabilitation program. Outcomes will include UE use in real-world environments and self-perceived changes in UE use.
- Conditions
- Stroke
- Being tested
- Therapist guided training, Upper extremity (UE) Training
- Keywords
- Stroke, upper extremity, motivational interviewing, shared decision making, ecological momentary assessments, self-initiated training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist guided trainingBehavioural
Therapist guided period delivered virtually (WebEx/Zoom). Participants will be patients associated with NYULH and will have access to Zoom. Each session will last 45 min, and will completed 3x/week by research therapists, who are part of the study.
Upper extremity (UE) TrainingBehavioural
The 4-week UE training is completed in the participants home on their own and communication with study staff is virtual. Participants will receive daily communication through the Expiwell app to answer survey questions related to adherence, and safety/adverse events. Participants will also complete weekly check-ins with their research therapist over Zoom to answer questions about difficulties related to UE training activities, refinement of training goals, and to receive feedback on their training performance. Each weekly check-in will be approximately 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Subjects with motor impairment will work closely with an occupational therapist to identify a goal and select activities that they will work on at home to improve the function of their affected arm. Receives: Behavioral: Therapist guided training; Behavioral: Upper extremity (UE) Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 4 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 6 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 8 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 11 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 22 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 29 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 37 visit
Rates of adherence at individual and group level measured through frequency
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Measured: Day 39 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 4 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 6 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 8 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 11 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 22 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 29 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 37 visit
Rates of adherence at individual and group level measured through intensity
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Measured: Day 39 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 4 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 6 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 8 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 11 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 22 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 29 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 37 visit
Rates of adherence at individual and group level measured through duration
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Measured: Day 39 visit
Decision making factors effecting the program adherence through semi-structured interviews
Semi-structured interviews will be conducted with all participants to collect qualitative data on participants' experiences related to the shared decision-making process in phase 1, and adherence to arm training in phase 2 of study.
Measured: Day 39 visit
Secondary outcomes (4)
Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up
FMA is a valid and reliable UE assessment to measure motor impairment in stroke. It consists of 33 items reflecting typical shoulder and hand motions in and out of synergy patterns characteristic of motor recovery after stroke. It is the gold standard performance-based assessment in UE stroke rehabilitation with an established minimal clinically important difference (MCID) of 4.25-7.25 points for chronic stroke patients.
Measured: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up
Motor Activity Log (MAL) is a valid and reliable self-report questionnaire for individuals in the subacute and chronic phase after stroke. Originally created as the primary outcome for Constraint Induced Movement Therapy, the MAL captures spontaneous use of the affected UE in daily life. It consists of 28 items reflecting basic and instrumental activities of daily living items. Scoring is based on an ordinal scale ranging from 1-5, and final scores are determined by calculating the mean of all item scores. This study will use the amount of use subscale for this study.
Measured: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up
The Canadian Occupational Performance Measure (COPM) is a valid and reliable individualized self-report measure that quantifies a participants' perception of everyday performance. Participants rate their change in their performance and satisfaction on a scale of 1 (unable to perform/not satisfied) to 10 (able to perform, extremely satisfied). A change of two or more points is considered clinically significant.
Measured: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.
Wrist worn accelerometers can be used to provide objective, valid, and reliable data on general UE motion in home settings. As a secondary outcome for adherence, we will collect bilateral UE accelerometry data continuously for 24 hours at all timepoints to determine if there are any changes in UE motion of the affected side in relation to the unaffected side before and after the intervention. Commercially available Actigraph GT9X Link wrist sensors will be used to collect bilateral UE motion at baseline, discharge, and follow up.
Measured: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start22 Sep 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Sponsor
- Investigators
- Grace Kim, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032638
- Sponsor's protocol ID
- 21-00513
- Status last verified
- Oct 2022
- First submitted
- 26 Aug 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Kim GJ, Gahlot A, Magsombol C, Waskiewicz M, Capasso N, Van Lew S, Goverover Y, Dickson VV. Protocol for a remote home-based upper extremity self-training program for community-dwelling individuals after stroke. Contemp Clin Trials Commun. 2023 Mar 17;33:101112. doi: 10.1016/j.conctc.2023.101112. eCollection 2023 Jun.
PubMed 37113325
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence in Upper Extremity Home-based Rehabilitation Through Motivational Interviewing and Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT05032638
- Acronym / sponsor ID
- 21-00513
- Conditions
- Stroke
- Keywords
- Stroke, upper extremity, motivational interviewing, shared decision making, ecological momentary assessments, self-initiated training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposal is to determine the feasibility of implementing Ecological Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence for a 4-week self-initiated arm training protocol. A non-randomized feasibility study using a 4-week UE training protocol will be conducted in 15 individuals within the first 12 months post-stroke living in the community. EMA data will be collected using a mobile app to automate real-time collection of adherence data on a daily basis. MI will be used to produce self-generated training plans (training goals, training schedule), guided by the therapist before the start of training.
Detailed description
Using a mixed methods design, the study will collect quantitative data before, during, and after training. Qualitative data will be collected after the training period and analyzed to explain the quantitative findings in depth, within the context of everyday life. Study aim 1 is to evaluate the feasibility of using EMA to measure adherence and of applying the MI approach. Quantitative data will include four indicators of adherence and accuracy. Interview responses will be used as qualitative data to elucidate participants' acceptance of the MI approach and feedback on using the EMA app. Study aim 2 is to explore to what extent UE outcomes change after the 4-week self-initiated home-based rehabilitation program. Outcomes will include UE use in real-world environments and self-perceived changes in UE use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Therapist guided training, Behavioral: Upper extremity (UE) TrainingSubjects with motor impairment will work closely with an occupational therapist to identify a goal and select activities that they will work on at home to improve the function of their affected arm. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (> 18 years old) diagnosed with stroke at least 6 months ago at the time of screening
- Living in the community
- Have presence of UE motor impairment on the affected side (Fugl-Meyer Assessment scores < 66)
- Availability of mobile technology (tablet or smartphone) with internet connection to use phone app and Zoom videochat)
- Be medically stable
Key exclusion criteria (5 listed)
- Currently receiving active occupational or physical therapy for the treatment of the affected UE
- Presence of severe cognitive impairment (Mini Mental Status Exam <24)
- Self-reported moderate to severe pain of the affected UE with use
- Presence of unilateral spatial neglect (Star Cancellation Task scores < 44)
- Presence of neurological diagnosis other than stroke.
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 |
|---|---|---|
| Therapist guided trainingTherapist guided period delivered virtually (WebEx/Zoom). Participants will be patients associated with NYULH and will have access to Zoom. Each session will last 45 min, and will completed 3x/week by research therapists, who are part of the study. | Behavioural | Experimental Group |
| Upper extremity (UE) TrainingThe 4-week UE training is completed in the participants home on their own and communication with study staff is virtual. Participants will receive daily communication through the Expiwell app to answer survey questions related to adherence, and safety/adverse events. Participants will also complete weekly check-ins with their research therapist over Zoom to answer questions about difficulties related to UE training activities, refinement of training goals, and to receive feedback on their training performance. Each weekly check-in will be approximately 45 minutes. | Behavioural | Experimental Group |
Primary outcome
Rates of adherence at individual and group level measured through frequency
Time frame: Day 4 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 6 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 8 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 11 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 22 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 29 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 37 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through frequency
Time frame: Day 39 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through intensity
Time frame: Day 4 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 6 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 8 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 11 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 22 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 29 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 37 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through intensity
Time frame: Day 39 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through duration
Time frame: Day 4 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 6 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 8 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 11 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 22 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 29 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 37 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Rates of adherence at individual and group level measured through duration
Time frame: Day 39 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Decision making factors effecting the program adherence through semi-structured interviews
Time frame: Day 39 visit
Semi-structured interviews will be conducted with all participants to collect qualitative data on participants' experiences related to the shared decision-making process in phase 1, and adherence to arm training in phase 2 of study.
4 secondary outcomes
Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up
Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up
Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up
Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.
Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
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 1 Nov 2022.
- Derived from this study: PubMed 37113325Kim GJ, Gahlot A, Magsombol C, Waskiewicz M, Capasso N, Van Lew S, Goverover Y, Dickson VV. Protocol for a remote home-based upper extremity self-training program for community-dwelling individuals after stroke. Contemp Clin Trials Commun. 2023 Mar 17;33:101112. doi: 10.1016/j.conctc.2023.101112. eCollection 2023 Jun.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Grace Kim, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist guided training and Upper extremity (UE) Training in people with Stroke, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 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 1 Nov 2022. 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 United States. 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?
Rates of adherence at individual and group level measured through frequency (time frame: Day 4 visit). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.