Abstract
Background:
Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA.
Objective:
The study aims to identify the required dose of a behavior change technique intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD).
Methods:
The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and behavior change techniques to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions.
Ethics and dissemination:
This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines.
Registration details:
This trial is registered on www.ClinicalTrials.gov (Number NCT05273723).
Keywords: behavior change technique, cardiovascular disease (CVD), dose finding, personalized trial, personalized, physical activity, statin, virtual
1. Introduction
Cardiovascular diseases (CVDs) including ischemic heart disease, stroke, heart failure, and peripheral arterial disease remain among the most prevalent cause of mortality and morbidity in the United States [1–3]. Consistently low levels of physical activity (PA) have been recognized as a leading contributor to poor cardiovascular health [4]. Individuals who engage in regular PA have been shown to have lower levels of CVD risk factors [4]. Even low levels of PA that fall below the minimum World Health Organization (WHO) recommendations can improve cardiovascular health among adolescents and reduce all-cause mortality in adults [4]. Low intensity PA, such as walking, has been shown to reduce the risk of chronic disease and improve functional capacity in a dose-dependent manner [5, 6].
Dyslipidemia is characterized by heightened plasma cholesterol, increased triglyceride levels, and/or reduced high-density lipoprotein (HDL) cholesterol levels [7]. HMG-CoA reductase inhibitors (commonly known as statins) reduce the effects of dyslipidemia and assist in CVD prevention and treatment. Statin therapy is extremely effective for reducing CVD risk but the addition of other interventions to improve cardiovascular health has been shown to produce benefits beyond statin therapy alone [8–12].
Compared to PA alone, statin therapy has been shown to be more effective for lowering blood triglyceride levels [13]. However, among those already prescribed statin medication, evidence suggests that the combination of statin medication and PA can lower CVD mortality risk more than either therapy alone [11, 12]. The combination of statin therapy and PA has also been shown to improve cognitive functioning and reduce statin therapy side effects (including myalgia, myopathy, and new onset diabetes mellitus) [14–16]. Side effects from statin medications are one of the major reasons for statin discontinuation[17]. Physical activity may reduce the likelihood of statin discontinuation by addressing these potential side effects of statin therapy. This suggests that increasing PA among individuals at elevated risk for cardiovascular disease who are prescribed statin medication may independently reduce risk of CVD while enhancing the effectiveness of their prescribed statin medication.
Multi-component behavior change interventions have been demonstrated to increase PA successfully[18–22]. However, the duration of these interventions and frequency of BCT delivery can vary significantly between studies [21]. This can lead to confusion about what intervention length is needed to meaningfully increase PA. Some researchers have suggested using dose-finding methods from pharmaceutical studies to identify the effective minimal length of a behavioral intervention [23, 24]. Applying these methods to behavioral interventions for PA would allow behavioral researchers to determine the length of the intervention (or intervention dose) required to make a meaningful change.
In this behavioral dose-finding trial, we propose using state-of-the-art dose-finding methodology to determine the minimum effective dose (MED) of multi-component behavior change technique (BCT) intervention necessary to increase levels of PA among participants using primary prevention statin therapy. This study will employ a modified version of the time-to-event continual reassessment method (TiTE-CRM) [25] to identify the MED of the BCT intervention. The TiTE-CRM model has traditionally been used to determine a maximum tolerated dose in pharmacologic agents, though it can also be applied to distinguish a MED. The MED is defined as the smallest dosage of a particular drug or intervention that will elicit a clinically discernable response [26]. The BCTs that comprise the current intervention, namely Goal Setting, Action Planning, Self-Monitoring of Behavior, Feedback on Behavior, and Prompts/Cues, have all been proven to be constructive in improving health behaviors, including PA [27–29]. The multi-component BCT intervention will be delivered once per day. If successful, the results of the current study will provide valuable information about the dose of a multi-component behavioral intervention comprised of five BCTs needed to increase PA among both researchers and clinicians.
2. Methods
2.1. Study design
This dose-finding trial will enroll 42 participants (in 14 cohorts of 3 participants each) to identify the MED, defined as a duration that increases walking by 2,000 more steps per day between run-in and follow-up periods with 80% probability. All participants will undergo a two-week run-in period, variable intervention duration (“dose”), and two-week follow-up period. The first cohort of three participants will receive a five-week multi-component behavioral change technique (BCT) intervention. Subsequent cohorts will receive varying BCT intervention duration (from 1 week to 10 weeks in length) where the duration is determined by the MED estimate according to the modified TiTE-CRM model and data from previously cohorts enrolled in the study. Figure 1 shows how this process will work for the first two cohorts. After completion of the intervention, participants will undergo a two-week follow-up period during which they will not receive the intervention but will continue data collection. The current trial is an adaptive design trial that utilizes participant data for intervention assignment but does not randomize treatment assignment.
Figure 1.
TiTE-CRM dose selection scenario
Note: Following the first cohort (which receives a 5-week intervention dose), if most participants are successful in achieving their goal of an increase in walking (i.e., ≥ 2,000 steps/day in follow-up compared with baseline), a lower dose will be administered to the next cohort; in this example, a 3-week intervention dose. If there is no increase in walking, the subsequent cohort will receive a longer dose intervention (7-week duration in this example). This process will continue with each subsequent cohorts dose being informed by the performance of participants in the prior cohort.
Participants will be provided with a commercially available, non–near field communication (NFC) Fitbit Charge 5 device to measure PA levels and an eCAP smart pill bottle from Information Mediation Corporation to measure medication adherence. All enrolled participants will be provided with a Fitbit study account with a unique identifier that has been created by the research team with no identifying information to the participant. The Fitbit will collect data including daily steps, floors climbed, activity intensity, sleep duration, battery life, last sync, and estimated minutes in sleep stages. A file linking the Fitbit identifier to the study participant will be housed in a Northwell-approved drive to store protected health information (PHI) and be accessible only by members of the study team listed in the Institution Review Board (IRB) application. The eCAP bottle is an electronic content monitor that tracks medication usage without active participant input and without using any downloadable app. eCAP stores information about the opening of the pill bottle, but no patient information or identifying data is stored on the device. Compliance data will be available for download by the study team upon receipt of the eCAP smart pill bottle at the end of the research.
Measures of PA and medication adherence will be collected by the Fitbit and eCAP bottle continuously throughout baseline, intervention, and follow-up periods. In addition to PA and medication adherence, all participants will provide demographic data (e.g., age, sex) and assessments of five potential mechanisms of action (MoAs) by which the BCT intervention may influence PA (i.e., walking) behavior (i.e., “beliefs about capabilities/self-efficacy,” “behavioral regulation/intrinsic regulation,” “feedback processes/discrepancy in behavior,” “motivation”, and “environmental context and resources”). These MoAs have been previously identified as important mechanisms of the BCT interventions utilized in this trial[30] and/or have been linked with PA in prior research[30–34]. Study recruitment began in April 2022, and the study completion is anticipated to occur in April 2023.
2.2. Study population
We will recruit 42 individuals from within the Northwell Health system, which is comprised of approximately 80,000 employees and 5.5 million patient encounters annually. Northwell Health offers a large pool of potential participants affiliated with the health system. All participants in the study will self-identify as having low levels of PA and are currently being prescribed statin medication (see Table 1).
Table 1.
Inclusion and exclusion criteria
| Inclusion Criteria | Exclusion Criteria |
|---|---|
|
|
2.3. Recruitment
Potential participants will primarily be recruited via advertising and posting across established Northwell communication channels, including email and employee platforms. This extensive electronic communication system allows for the rapid delivery of recruitment materials directly to potentially eligible participants including, but not limited to, advertisement on TV monitors in office locations in collaboration with Northwell Marketing. In addition, potentially eligible participants will be recruited using the Northwell Health electronic health record (EHR). Recruitment links will lead interested individuals to an online screening survey containing questions regarding study inclusion and exclusion criteria and who to contact for more information. If a potential participant indicates that they are eligible they will be presented with an informational video briefly describing study design and participant responsibility. If a potential participant is deemed ineligible, they will be redirected to another site and immediately notified. If the participant is deemed eligible, the study staff will send the eligible participant an email containing a link to the electronic consent form and additional information.
2.4. Consent
Persons who are eligible to participate after the screening survey will be directed to a short video explaining key details of the study protocol alongside an electronic copy of the consent form. A four-question assessment measure will assess participant understanding of the protocol and consent process. Consent will be electronically obtained and a copy of the consent will be e-mailed to the participant for their personal records. Participants may contact a member of the study team with questions about the research. Both the research phone and email inbox will be monitored daily by consenting coordinators. Signed consent forms will be stored electronically on a Health Insurance Portability and Accountability Act (HIPAA)–compliant, Northwell Health–approved shared drive accessible only to the IRB-approved study staff. An example consent form can be found in the manuscript appendix. Prior to receiving study devices, participants will read and sign a device allocation document letting them know which devices they may keep upon study completion and which should be returned to study staff.
2.5. Baseline period
The first two weeks of the study will be a baseline assessment period. Participants will be mailed a commercially available Fitbit and eCAP bottle after onboarding is complete. Participants will be encouraged to wear their Fitbit day and night, sync it with the Fitbit application on their phone at least every two days, and charge it at least every four days. Upon receiving the eCAP bottle, participants will fill it using their existing statin prescription.
2.6. Assignment of interventions
After passing baseline, participants will receive a BCT intervention, the length of which varying 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 [35]. The study design aims to find a dose that increases walking by at least 2,000 steps per day with 80% probability. The first cohort of participants will be treated at the median dose level, which is five weeks of the multi-BCT intervention. Subsequent cohorts will be assigned based on estimates of dose-response of the intervention, evaluated based on a pre-specified dose-response model using all available observations enrolled to the study. An example of how dose assignment might work following the first cohort is shown in Figure 1. The interim calculations will be performed using a web app developed by the study statistician using methods utilized in a previous trial [36]. The general methodology of the TiTE-CRM has been documented in prior publications [26]. Specifically, for the present study, the dose-response model was calibrated such that the TiTE-CRM would eventually select a dose that improves daily step counts with 75% to 85% probability—i.e., within 5 percentage points of our target MED [35]. The traditional CRM may incur accrual delays because it requires completely following the currently enrolled participants before enrollment of the next cohorts. Thus, we use the modified TiTE-CRM to allow staggered participant entry. This modified method differs from the CRM by also using the step count data collected during the intervention periods in addition to the follow-up periods. To ensure sufficient information accrued in the most recent cohorts, we also impose one-week waiting windows between cohorts. That is, we will not enroll participants to a new cohort unless all the participants in the prior cohort have completed at least one-week of the intervention period. To illustrate this process in the full sample, Figure 2 shows two scenarios of how doses may be assigned based on the performance of prior cohorts.
Figure 2.
Potential trial dose assignment scenarios using TiTE-CRM
2.7. Interventions
Once a participant successfully completes baseline data collection and is found to meet all eligibility criteria, they will be assigned the multi-BCT intervention of a specific duration. During the intervention period, participants will continue to wear their activity monitor and use the eCAP bottle to take their statin medications. During the BCT intervention, participants will receive daily text-message reminders for all five of the BCTs, shown to be effective for increasing positive health behaviors (including PA): goal-setting, action-planning, self-monitoring, feedback, and prompts/cues [27–29]. Timing of text messages will be based on the participants’ preferred time for walking.
Goal setting is understood as setting a goal defined in terms of the behavior to be achieved. For this study, individuals will receive a text message reading, “Is your goal today to walk an extra 2,000 steps (9,000 total steps)? (Yes/No)” for that day.
Action planning is detailing the plan of where, for how long, and at what time PA is going to be performed. This BCT involves encouraging one to decide to act or set a behavioral resolution by forming detailed plans that link the behavior to specific situational cues. Participants will receive a text asking them to “Take one minute and plan for today how, where, and when you can walk an extra 2,000 steps (9,000 total steps). Have you done this? (Y/N).”
Self-monitoring of behavior is defined as monitoring and recording behavior. For this study, a participant will be asked to “Check your Fitbit for yesterday. Did you take an extra 2,000 steps (9,000 steps total)? (Y/N).”
Feedback on behavior is defined as providing informative or evaluative feedback on the performance of the behavior. For example, if a participant had set a goal to walk 2,000 extra steps for the day, the next day they receive a message that reads, “You met your goal yesterday by walking at least an extra 2,000 steps (you walked 9,000 steps total)” or “You didn’t meet your goal of walking at least 2,000 extra steps yesterday (you walked 8,000 steps total).”
Lastly, prompts/cues is defined as introducing or defining environmental and social stimuli with the purpose of cueing behavior. For this study, participants will be sent a text at a scheduled time reminding them to walk a set number of steps: “Remember to walk 9,000 total steps today (2,000 steps extra).”
During the intervention period, participants will also complete one questionnaire every two weeks, where the total number completed will vary according to the duration of their multi-BCT intervention. For example, a participant with total trial duration of six weeks will complete this questionnaire three times. As stated previously, the first cohort of three participants who are eligible to continue to the intervention phase will be assigned to a BCT intervention that lasts for five weeks. All other participants will be assigned to a group that receives five daily BCTs via text message, but the duration of the intervention will be variable. For instance, participants may be assigned to a group that is asked to receive a BCT intervention for 1 week, 2 weeks, 3 weeks, etc. up to 10 weeks in length.
2.8. Participant timeline
Figure 3 illustrates the participant timeline. Participants may experience intervention durations varying between 1 and 10 weeks with total trial durations varying between 5 and 14 weeks.
Figure 3.
Participant timeline
2.9. Adherence to study protocol
Participant adherence to the protocol will be assessed during the first 14 days of the baseline assessment period. During baseline assessment, study staff will review participant adherence to wearing their Fitbit, adherence to statin medications, and completion of required study surveys. Participants will have short education videos made available to them alongside protocol reminders via text message, and they will be encouraged to contact study staff with concerns by phone or email.
3. Outcomes
3.1. Primary Outcome
In this study, the primary outcome is a successful increase in walking between the baseline and follow-up periods. Specifically, in the current study, a successful increase in walking will be defined as an average of 2,000 steps of walking increased per day between run-in and follow-up periods. This will be determined by calculating the mean daily step totals for the baseline and follow-up periods. If the average steps in follow-up are at least 2,000 steps per day greater than during run-in, the outcome will be judged successful. The minimum effective dose (MED) will be identified for the dose of the intervention (in weeks), which leads to a successful increase in at least 80% of participants who have received it. Participant steps will be assessed continuously using a Fitbit mobile device.
3.2. Secondary and exploratory outcomes
Secondary outcomes for the current study include within-participant changes in daily steps (continuous variables), changes in potential MoAs for the BCT intervention, and changes in medication adherence. As in the primary outcome, steps will be measured continuously and aggregated by day. For the secondary outcome, averages will not be calculated by period (e.g., baseline versus follow-up). Instead, change in daily steps will be examined continuously.
In this study, we also assess five potential MoAs of the BCT intervention on PA. All MoAs will be assessed at the completion of baseline and will be assessed every two weeks until the end of the follow-up period.
Self-efficacy will be assessed using the Self-Efficacy for Walking (SE-W) scale [37], a 10-item measure assessing a participant’s capabilities to walk for durations of 5 to 50 minutes.
Intrinsic regulation will be assessed using a four-item measure assessing intrinsic regulation, a subscale of the Behavioral Regulations in Exercise Questionnaire Version 2 (BREQ-2) [33].
We also assess within-person change in discrepancy in behavior with a single item measuring discrepancy in behavior. This measure was adapted for one examining discrepancy in behavior for alcohol use [38]. The text of the measure is “How large is the difference between your current walking behavior and your goal concerning your walking?”
Within-person change in motivation will be assessed with a message stating “I feel motivated to walk each day.” Participants will rate this item on a scale of 0 (“Not true at all”) to 7 (“Very true”) with higher scores indicating higher levels of motivation.
Within-person changes in environmental context and resources will be assessed using a checklist of seven potential barriers to walking. This list was adapted from a prior study identifying barriers for walking [31]. Barriers are coded on a 1 (“Not often at all”) to 5 (“Very often”) scale and averaged to create a total score with higher scores indicating that the listed barriers had greater effects on walking.
Participant adherence to statin medication will be assessed continuously using a smart electronic pill bottle. Daily medication adherence will be recorded for each participant across the entire duration of the study using the eCAP smart pill bottle.
An additional study aim is identification of participant heterogeneity in the amount of time required to reach a successful increase in daily steps (defined as an increase of 2,000 or more steps per day over a 2-week period compared to run-in). Average step counts will be calculated for each two-week block during the intervention and follow-up periods. Average steps per day in these blocks will be compared with the average daily steps in the run-in period. Once a successful increase has been detected, the time to achieve this treatment response will be recorded. Differences in duration to successful increases in PA will be examined between participants using mixed effects regression models.
4. ANALYSIS
4.1. Sample size calculation
The sample size of 42 participants was chosen to have enough participants to obtain a preliminary assessment of the MED for the multi-BCT intervention to increase walking between baseline and follow-up periods. Sample size estimates are based on the likelihood of 80% of individuals who are assigned a particular dose achieving a successful increase in walking (defined as an average of 2,000 or more per day during follow-up relative to baseline). The dose-efficacy model is calibrated such as that the modified TiTE-CRM will eventually select a BCT duration associated with 75%−85% successful PA success, i.e., within 5 percentage points of our target of 80% [39]. The sample size of 42 participants is determined to achieve 60% probability of correct selection (PCS) under logistic dose-efficacy curves with an odds ratio of 2 [40].
4.2. Primary analysis
The MED will be defined as the smallest multi-BCT dose duration associated with a successful PA increase (defined as an average increase of 2,000 steps per day) between the 2-week run-in and 2-week follow-up periods in at least 80% of participants. The MED will be estimated based on the modified TiTE-CRM, which is an adaptive model-based, dose-finding design for estimating the maximum tolerated dose in pharmacologic agents. In this study, we will adapt the TiTE-CRM for the purpose of MED estimation. Once the study has completed enrollment, we will identify which dose of the BCT intervention (in weeks) is associated with ≥80% of participants achieving the goal of an average of 2,000 steps per day increase between the baseline and follow-up periods. Means and standard deviations of step scores for baseline versus behavioral change strategy treatment period will be visualized using a column graph.
4.3. Secondary analyses
The effects of treatment on continuously measured daily steps will be assessed using generalized linear mixed models (GLMM). In this model, we will specify a fixed effect for the intervention, time, and interaction of the intervention and time. A random effect will be specified for participant. This autoregressive model (AR[1]) will also account for possible autocorrelation and linear trends between daily steps across time.
To identify estimates of the indirect effect of the BCT intervention on PA via potential mediator MoAs, we will conduct the analysis in three steps using mixed effects regression models. First, we will estimate the direct effect of the BCT intervention on daily steps. Second, we will estimate the effect of the BCT intervention on each potential MoA. Third, we will estimate the mediation effect of the BCT intervention on PA via potential MoAs using natural effects models for effect decomposition into direct effect and indirect effect, mediated by increase in each MoA, relative to baseline.
The effect of the multi-BCT intervention on adherence to statins will be examined across the study duration. As with daily steps, GLMM models accounting for serial autocorrelation will be utilized to examine any beneficial effects of the intervention on daily adherence to statin medications. Fixed effects will be specified for the intervention, time, and a time-by-treatment interaction, and a random effect will be specified for participants.
Participant variability in the amount of time required to reach a successful increase in daily steps will be examined. Average step counts will be calculated for each two-week block during the intervention and follow-up periods. Average steps per day in these blocks will be compared with the average daily steps in the run-in period. Once a successful increase has been detected, the time to achieve this treatment response will be recorded. Differences in duration to successful increases in PA will be examined between participants using mixed effects regression models. Participant demographics, type of statin medication, and dose of statin medication will be examined as potential moderators of the intervention effect on PA.
The baseline level of participants may also influence the effectiveness of each intervention dose on increases in PA. To account for this, we will conduct sensitivity analyses examining how average steps during the baseline period influence the effectiveness of the intervention on PA.
5. Discussion
Physical activity is a vital component in maintaining a healthy life. Physical activity has also been associated with reducing risk of chronic illnesses and improving psychological health and functional status [41, 42]. The benefits of PA are especially important among individuals at elevated risk for CVD, such as those on primary prevention statin therapy. For them, identifying what intervention effectively increases PA in addition to how long an intervention is needed to see meaningful change in walking behavior is important. The goal of the current study is to utilize a proven behavioral intervention strategy (namely a multi-BCT intervention with components previously shown to increase PA) and identify the clinically effective dose of this intervention among statin users. Further, we hope that increasing PA among statin users may increase reductions in CVD by increasing adherence to statin medications.
Identifying a specific dose will serve clinicians in better understanding how best to improve patient’s PA. For researchers, identifying the dose-response for behavioral interventions is even more important. Once completed, this study will provide important guidance to researchers studying interventions to increase activity among individuals at elevated CVD risk. In addition, the study will also examine potential mechanisms of action of the intervention. We hope to ultimately provide greater information about how behavioral interventions increase PA rather than simply if they do. In sharing these details about the study protocol, we hope to inspire other researchers to adopt sophisticated methodological designs (such as the modified version of TiTE-CRM utilized in the current trial) to examine the associations between behavioral interventions and their outcomes more rigorously.
Patient and public involvement statement
Pilot data with participants was used to help determine which interventions were selected for the current trial. We did not directly involve participants in any other elements of the design or conduct of this trial.
Data monitoring
Since the study activities involve no more than risks encountered in daily life (increased time spent walking by healthy, working individuals), the study has received approval from the NIA for a safety monitor. Dr. Zenobia Brown has been approved to provide safety monitoring for this pilot. Dr. Brown is a family medicine clinician and oversees Northwell’s Health Solutions programs. Also, given that study activities involve no more than risks encountered in daily life (increased time spent walking by healthy, working individuals), the study has not convened a DSMB (Data and Safety Monitoring Board).
Harms
Treatment adverse events
This study poses a minimal risk of physical harm to subjects. One risk of taking part in this study is the possibility of a loss of confidentiality or privacy. The study team plans to protect privacy by only sharing necessary information about participants to those outlined in the consent form. All subjects will be informed that their responses are confidential and that they may refuse to participate in the project or withdraw at any time without explanation, and that such action will not affect their future interactions with their health care providers, employment, educational studies, or the research study. The risk of loss of confidentiality will be minimized by securely storing data including PHI in a Northwell-approved database and minimizing the use of PHI.
There is no additional risk with using a Fitbit activity monitor for research as compared to using the device as a consumer, including mild skin irritation (i.e., contact dermatitis) which occurs among a small proportion of users. Participants will be instructed via the consent form on methods to reduce irritation (i.e., keep the band clean and dry) and that they can remove the band for a brief period. There are no known risks associated with the utilization of the BCTs employed in this intervention. It is possible that messages prompting PA may cause mild stress in participants who are ambivalent about increasing their step count. Increasing the step count by 2,000 steps per day in ambulatory persons without mobility impairments or safety limitations represents no more than minimal risk. Mild symptoms of increased activity such as fatigue or muscle soreness may be experienced.
There are no known risks to utilizing eCAP smart pill bottle. The vial smart cap meets all federal stands for safety (childproof). No patient information or identifying data is stored on the device. There is no GPS tracking from the eCAP device. The proposed questionnaires are not anticipated to pose risk to the participants. Participants will receive text message notifications with a secure link to a survey that can be accessed via a smartphone. All survey responses will be directly entered by participants in an electronic format (secure, HIPAA compliant RedCap database).
Costs
This research study is funded by the National Institutes for Health (P30). All study-related devices will be provided to participants at no cost. Participant insurance will not be billed. This study uses text messaging to deliver notifications, reminders, and study questionnaires. Standard message and data rates from the participant’s wireless carrier may apply to the study participant. Study participants will not be compensated for any costs related to data usage or sending or receiving text messages by the study or by members of the study team
Compensation
There is no payment to subjects for participation in this research, however, participants who are randomized into the intervention phase will be allowed to keep their commercially available Fitbit Charge 5 (a value of up to $150.00) device at the end of the study. Participants will be required to return their eCAP smart pill bottle at the end of the research study.
Ethics
All amendments to the protocol will be submitted to the ethics committee and Northwell Health IRB for approval. Prior to participation in the trial, all participants will complete informed consent.
Dissemination
The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines. Trial results will be reported to study collaborators and participants following study completion.
Supplementary Material
Acknowledgments
We are grateful for the contributions and support of the Northwell Health system, Fitbit, and eCAP smart pill bottle by Information Mediation Corporation for providing the investigators with the support and tools for the development and implementation of this trial.
Funding
This work was supported by the National Institute on Aging (NIA) P30AG063786-01. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The views expressed in this paper are those of the authors and do not represent the views of the National Institutes of Health, the U.S. Department of Health and Human Services, or any other government entity. Karina W. Davidson is a member of the U.S. Preventive Services Task Force (USPSTF). This article does not represent the views and policies of the USPSTF. This research is funded by the NIH; thus, a Certificate of Confidentiality has been issued for this research. Certificates of Confidentiality (CoCs) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations.
Footnotes
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Declaration of interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Declaration of competing interest
None declared.
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