Medication AdherencePhase 1NCT05273736
A BCT Intervention for Medication Adherence Among Individuals on Statins
A Phase 1 study testing 5 Behavioral Change Techniques in people with Medication Adherence, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of medication adherence among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- 5 Behavioral Change Techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 7 Oct 2024
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 or older;
- Northwell Health employee/affiliate;
- Ambulatory without limitations: has never been advised by a clinician that increasing low-intensity walking would be unsafe;
- Prescribed statin medication;
- Self-reported low levels of adherence to statin medications;
- Access to and capable of using a smart cellular phone;
- After 2 week run-in, objectively-verified low levels of adherence to statin medications (<60% of days using statin as prescribed) as documented by electronic pill bottles;
- English speaking.
Who cannot join
- Age less than 18 years;
- Not a Northwell Health employee/affiliate
- Non-ambulatory or unsafe/not recommended to participate in a walking program
- Not prescribed statin medication;
- Does not use or not willing to use Vivo Health as a pharmacy for prescription fills;
- History of CVD;
Show all 12Show fewer
- Inability to comply with study protocol during 2 week run-in;
- Does not speak English;
- Unavailable for follow-up;
- Cognitive impairment;
- Severe mental illness (e.g., bipolar disorder or schizophrenia);
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Health System Science
New York, New York, 10022
About this study
Official title: The Effect of a Multi-Component Behavior Change Technique Intervention on Medication Adherence Among Individuals on Primary Prevention Statin Therapy: A Dose-Finding Pilot Study
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of medication adherence among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week run-in period where medication adherence levels will be measured using a smart pill bottle and physical activity (PA) will be measured using Fitbit wearable devices. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a 20% medication adherence increase between the run-in and the follow-up periods.
Read the detailed description
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change technique (BCT) intervention required to increase statin medication adherence among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The long-term goal is to prevent CVD. The current project will utilize a modified version of the time-to-event continual reassessment method (TiTE-CRM), a state of the art dose finding methodology, to determine the MED of a multi-component BCT intervention required to increase the proportion of days adherent to statin medications by 20%. The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues.
The study sample will include individuals on primary prevention statin therapy who are at elevated risk for CVD. For this research, the investigators will enroll participants with low levels of self-reported adherence to statin medications, with the goal of randomizing 42 persons to the intervention. Enrolled participants will complete a 2-week run-in period where levels of adherence to statin medications will be assessed using a smart pill bottle and physical activity levels will be measured using a Fitbit wearable device. During the run-in period, data from the smart pill bottle will be used to verify objective non-adherence to statin medications (defined as taking statin medications as prescribed for 60% of days or less during run-in). Individuals who do not meet objective levels of nonadherence to statin medications and/or are non-adherent to the protocol will be excluded and will not be randomized to the intervention. Following the run-in, the investigators will randomize 42 participants into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose of a multi-BCT intervention. Assignment to doses will utilize modified TiTE-CRM methodology to adjust the dose for each cohort based on the results from the previous cohort. Following the intervention, all participants will be assessed over a 2-week follow-up period which includes passive data collection from the activity monitor, answering surveys and use of the electronic pill bottle to track medication adherence. The MED will be defined as the smallest BCT dose duration associated with a 20% increase in the proportion of days using statin medication as prescribed between the run-in and the follow-up periods in 80% of the sample receiving that dose. Adherence to statins will be defined using changes in weight of medication in the smart pill bottle. The investigators will also assess Mechanisms of Action (MoAs) to determine potential mediators of the BCT intervention on physical activity (PA). As some evidence suggests there are correlations between adherence and PA and that interventions targeting medication adherence also influence PA, the investigators will utilize Fitbit devices to determine whether the BCT intervention increase participant's levels of activity.
- Conditions
- Medication Adherence
- Being tested
- 5 Behavioral Change Techniques
- Keywords
- Behavior Change, Medication Adherence, Physical Activity, Walking, Statin, Cardiovascular Disease, Dose Finding, Continual Reassessment Method
- Medical subject headings
- Medication Adherence, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Behavioral Change TechniquesBehavioural
- Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal to take your medication as prescribed tomorrow.
- Action planning: prompt detailed planning of performance of behavior (must include a setting, frequency, duration, and intensity). Example: Develop a plan for taking your medication.
- Self-Monitoring of behavior: establish a method for person to monitor and record their behavior. Example: Did you take your statin medication today?
- Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You did not take your statin medication as prescribed yesterday.
- Prompts/Cues: introduce or define environmental or social stimulus with the purpose of prompting or cueing the behavior. The prompt or cue would normally occur at the time or place of performance. Example: Please remember to take your medication soon.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dose-finding study with 14 groups of 3 participants each. To identify the minimum effective dose (MED) to increase medication adherence by 20% between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined by the modified Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous subjects. Receives: Behavioral: 5 Behavioral Change Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure for change in Medication Adherence.
Participant medication adherence increase will be assessed between run-in and follow-up periods using the smart pill bottle. A successful adherence increase is defined as average daily adherence to statin medications in the 2-week follow-up period being higher by 20% or more than in the 2-week run-in period. The minimum effective dose (MED) will be defined as the smallest BCT dose duration associated with 80% of participants receiving that dose having a successful statin adherence increase between the run-in and the follow-up periods.
Measured: Medication adherence will be assessed continuously via the smart pill bottle and adherence will be calculated daily. The change in proportion of days adherent will be compared between the run-in and follow-up periods (5-14 weeks from run-in).
Secondary outcomes (7)
Within-person change in Medication Adherence.
Participant adherence to stain medication will be assessed continuously using a smart electronic pill bottle. Daily medication adherence will be recorded for each participant across the full duration of the study. Changes in medication between run-in and intervention phases will be compared using Generalized Linear Mixed Model Analyses.
Measured: Medication adherence will be assessed continuously via a smart pill bottle and adherence will be calculated daily. Change over time will be examined between the baseline, intervention, and follow-up periods (5-14 weeks from run-in).
Within-person change in Self-Efficacy.
Self-efficacy will be assessed using an adapted version of the PROMIS Item Bank v1.0, Self-Efficacy for Managing Chronic Conditions, Managing Medications and Treatment Short Form 8a, a 7-item measure assessing patient's capabilities to take their medications. Items are scored on a 1 "I am not at all confident" to 5 "I am very confident" scale. Scale scores will be converted to T-scores using methods from the PROMIS scoring manual based on item response theory, with higher scores indicating higher levels of self-efficacy.
Measured: Self-efficacy will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Behavioral Automaticity.
Behavioral automaticity will be assessed using an adapted version of the 4-item Self-Report Behavioral Automaticity Index (SRBAI) which assesses automaticity of behavior. Items are scored on a 1 "Strongly Disagree" to 7 "Strongly agree" scale, and summed to create a total score, with higher scores indicating greater behavioral automaticity.
Measured: Behavioral automaticity will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Discrepancy in Behavior.
This will be assessed with a single item stating "How large is the difference between your current medication taking behavior and the frequency of medication use prescribed by your doctor?" This item is rated on a scale of 1 "Not at all different" to 7 "Very different", with higher scores indicating greater levels of discrepancy in behavior.
Measured: Feedback Processes will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Motivation.
Motivation will be assessed with a message stating "I feel motivated to take my statin medications exactly as my doctor prescribed." Motivation will be rated on a scale of 1 "Not at all true" to 7 "Very True", with higher scores indicating greater levels of motivation.
Measured: Motivation will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Environmental Context and Resources.
Environmental context and resources will be assessed using a list of 4 potential environmental barriers to medication adherence taken from Fung and colleagues. Barriers are rated on a 1 "Not often at all" to 5 (Very often) scale, and summed to create a total score, with higher scores indicating that the listed barriers had greater effects on patient nonadherence to statins.
Measured: Environmental Context and Resources will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Daily Steps.
Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by run-in and follow-up periods to generate average daily steps in each period. Changes in daily steps between run-in and intervention periods will be compared using Generalized Linear Mixed Model Analyses.
Measured: Steps will be assessed continuously via worn activity tracker and step counts will be calculated daily. Change over time will be examined between the baseline, intervention, and follow-up periods (5-14 weeks from run-in).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start21 Jul 2022
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
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 Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Northwell 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 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study utilizes a modified Time-To-Event Continual Reassessment Method Dose-Finding Design
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karina Davidson, PhD, MASc, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273736
- Sponsor's protocol ID
- 21-0707
- Other IDs
- P30AG063786-01
- Status last verified
- Oct 2024
- First submitted
- 27 Dec 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Pooling trials together is a more efficient approach for deriving population-level estimates than conventional randomized controlled trials.
Publications
Butler MJ, Romain AN, Augustin R, Robles P, Friel CP, Chandereng T, Suls JM, Vrany EA, Vicari F, Cheung YK, Davidson KW. The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol. Trials. 2023 Aug 12;24(1):523. doi: 10.1186/s13063-023-07549-w.
PubMed 37573428
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-Component Behavior Change Technique Intervention on Medication Adherence Among Individuals on Primary Prevention Statin Therapy: A Dose-Finding Pilot Study
- ClinicalTrials.gov ID
- NCT05273736
- Acronym / sponsor ID
- 21-0707
- Conditions
- Medication Adherence
- Keywords
- Behavior Change, Medication Adherence, Physical Activity, Walking, Statin, Cardiovascular Disease, Dose Finding, Continual Reassessment Method
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of medication adherence among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week run-in period where medication adherence levels will be measured using a smart pill bottle and physical activity (PA) will be measured using Fitbit wearable devices. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a 20% medication adherence increase between the run-in and the follow-up periods.
Detailed description
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change technique (BCT) intervention required to increase statin medication adherence among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The long-term goal is to prevent CVD. The current project will utilize a modified version of the time-to-event continual reassessment method (TiTE-CRM), a state of the art dose finding methodology, to determine the MED of a multi-component BCT intervention required to increase the proportion of days adherent to statin medications by 20%. The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues.
The study sample will include individuals on primary prevention statin therapy who are at elevated risk for CVD. For this research, the investigators will enroll participants with low levels of self-reported adherence to statin medications, with the goal of randomizing 42 persons to the intervention. Enrolled participants will complete a 2-week run-in period where levels of adherence to statin medications will be assessed using a smart pill bottle and physical activity levels will be measured using a Fitbit wearable device. During the run-in period, data from the smart pill bottle will be used to verify objective non-adherence to statin medications (defined as taking statin medications as prescribed for 60% of days or less during run-in). Individuals who do not meet objective levels of nonadherence to statin medications and/or are non-adherent to the protocol will be excluded and will not be randomized to the intervention. Following the run-in, the investigators will randomize 42 participants into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose of a multi-BCT intervention. Assignment to doses will utilize modified TiTE-CRM methodology to adjust the dose for each cohort based on the results from the previous cohort. Following the intervention, all participants will be assessed over a 2-week follow-up period which includes passive data collection from the activity monitor, answering surveys and use of the electronic pill bottle to track medication adherence. The MED will be defined as the smallest BCT dose duration associated with a 20% increase in the proportion of days using statin medication as prescribed between the run-in and the follow-up periods in 80% of the sample receiving that dose. Adherence to statins will be defined using changes in weight of medication in the smart pill bottle. The investigators will also assess Mechanisms of Action (MoAs) to determine potential mediators of the BCT intervention on physical activity (PA). As some evidence suggests there are correlations between adherence and PA and that interventions targeting medication adherence also influence PA, the investigators will utilize Fitbit devices to determine whether the BCT intervention increase participant's levels of activity.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study utilizes a modified Time-To-Event Continual Reassessment Method Dose-Finding Design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 5 Behavioral Change TechniquesDose-finding study with 14 groups of 3 participants each. To identify the minimum effective dose (MED) to increase medication adherence by 20% between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined by the modified Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 18 or older;
- Northwell Health employee/affiliate;
- Ambulatory without limitations: has never been advised by a clinician that increasing low-intensity walking would be unsafe;
- Prescribed statin medication;
- Self-reported low levels of adherence to statin medications;
Key exclusion criteria (12 listed)
- Age less than 18 years;
- Not a Northwell Health employee/affiliate
- Non-ambulatory or unsafe/not recommended to participate in a walking program
- Not prescribed statin medication;
- Does not use or not willing to use Vivo Health as a pharmacy for prescription fills;
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 |
|---|---|---|
| 5 Behavioral Change Techniques1. Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal to take your medication as prescribed tomorrow. 2. Action planning: prompt detailed planning of performance of behavior (must include a setting, frequency, duration, and intensity). Example: Develop a plan for taking your medication. 3. Self-Monitoring of behavior: establish a method for person to monitor and record their behavior. Example: Did you take your statin medication today? 4. Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You did not take your statin medication as prescribed yesterday. 5. Prompts/Cues: introduce or define environmental or social stimulus with the purpose of prompting or cueing the behavior. The prompt or cue would normally occur at the time or place of performance. Example: Please remember to take your medication soon. | Behavioural | Intervention |
Primary outcome
Success or failure for change in Medication Adherence.
Time frame: Medication adherence will be assessed continuously via the smart pill bottle and adherence will be calculated daily. The change in proportion of days adherent will be compared between the run-in and follow-up periods (5-14 weeks from run-in).
Participant medication adherence increase will be assessed between run-in and follow-up periods using the smart pill bottle. A successful adherence increase is defined as average daily adherence to statin medications in the 2-week follow-up period being higher by 20% or more than in the 2-week run-in period. The minimum effective dose (MED) will be defined as the smallest BCT dose duration associated with 80% of participants receiving that dose having a successful statin adherence increase between the run-in and the follow-up periods.
7 secondary outcomes
Within-person change in Medication Adherence.
Time frame: Medication adherence will be assessed continuously via a smart pill bottle and adherence will be calculated daily. Change over time will be examined between the baseline, intervention, and follow-up periods (5-14 weeks from run-in).
Within-person change in Self-Efficacy.
Time frame: Self-efficacy will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Behavioral Automaticity.
Time frame: Behavioral automaticity will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Discrepancy in Behavior.
Time frame: Feedback Processes will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Motivation.
Time frame: Motivation will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Environmental Context and Resources.
Time frame: Environmental Context and Resources will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).
Within-person change in Daily Steps.
Time frame: Steps will be assessed continuously via worn activity tracker and step counts will be calculated daily. Change over time will be examined between the baseline, intervention, and follow-up periods (5-14 weeks from run-in).
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 15 Oct 2024.
- Derived from this study: PubMed 37573428Butler MJ, Romain AN, Augustin R, Robles P, Friel CP, Chandereng T, Suls JM, Vrany EA, Vicari F, Cheung YK, Davidson KW. The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol. Trials. 2023 Aug 12;24(1):523. doi: 10.1186/s13063-023-07549-w.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Pooling trials together is a more efficient approach for deriving population-level estimates than conventional randomized controlled trials.
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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.
Karina Davidson, PhD, MASc principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5 Behavioral Change Techniques in people with Medication Adherence, run by Northwell 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 8 inclusion and 12 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 15 Oct 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success or failure for change in Medication Adherence. (time frame: Medication adherence will be assessed continuously via the smart pill bottle and adherence will be calculated daily. The change in proportion of days adherent will be compared between the run-in and follow-up periods (5-14 weeks from run-in).). 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 NCT05273736, 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 15 Oct 2024.