A Series of Virtual Interventions for Chronic Lower Back Pain: A Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Butler, Mark J.; D’Angelo, Stefani; Kaplan, Melissa G.; Tashnim, Zarrin; Miller, Danielle; Ahn, Heejoon; Falzon, Louise; Dominello, Andrew J.; Foroughi, Cirrus; Chandereng, Thevaa; Cheung, Ken; Davidson, Karina W.

doi:10.1162/99608f92.72cd8432

Cited by 10 publications

(15 citation statements)

References 47 publications

(72 reference statements)

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“…The report of the primary findings from this study, entitled "A Series of Virtual Interventions for Chronic Lower Back Pain: A Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials" contains full details regarding the design and methods of the trial Butler et al (2022). This report focuses on personalizing trial findings for participants and presents details relevant to the feedback report.…”

Section: Methodsmentioning

confidence: 99%

“…Additional unvalidated questions regarding overall trial satisfaction as well as individual components of the trial were assessed for quality improvement purposes. Butler et al (2022) further report these outcomes in the primary outcome article for the trial. The feedback report to participants included several secondary outcomes.…”

Section: Primary and Secondary Outcomesmentioning

confidence: 99%

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Personalized Feedback for Personalized Trials: Construction of Summary Reports for Participants in a Series of Personalized Trials for Chronic Lower Back Pain

D’Angelo

Ahn

Miller

et al. 2022

Harvard Data Science Review

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Personalized (N-of-1) trials offer a patient-centered research approach that can provide important clinical information for patients when selecting which treatment options best manage their chronic health concern.Researchers utilizing this approach should present trial results to patients in a clear and understandable manner in order for personalized research trials to be useful to participants. The current study provides participant feedback examples for personalized trial reports using lay summaries and multiple presentation styles from a series of 60 randomized personalized trials examining the effects of massage and yoga versus usual care on chronic lower back pain (CLBP). Researchers generated summary participant reports that describe individual participant results using multiple presentation modalities of data (e.g., visual, written, and auditory) to offer the most appealing style for various participants. The article discusses contents of the participant report as well as participant satisfaction with the personalized summary report, captured using a satisfaction survey administered after study completion. The results from the satisfaction survey in the current study show that participants were generally satisfied with their personalized summary report. Researchers will use feedback from the participants in the current study to refine personalized feedback reports for future studies. This trial is registered in www.ClinicalTrials.gov (number NCT04203888).

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Section: Methodsmentioning

confidence: 99%

Section: Primary and Secondary Outcomesmentioning

confidence: 99%

Personalized Feedback for Personalized Trials: Construction of Summary Reports for Participants in a Series of Personalized Trials for Chronic Lower Back Pain

D’Angelo

Ahn

Miller

et al. 2022

Harvard Data Science Review

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“…Adherence will be evaluated using the Fitbit tracker and survey completion. Participants wearing the Fitbit for 12 or more hours per day, including at least 180 minutes of sleep time, will be defined as adherent [46,47]. During the 14 days of the baseline period, participants who do not achieve a minimum of 80% adherence to Fitbit tracker wear and study measures (including EMA and survey measures) will be withdrawn from the study before randomization.…”

Section: Adherencementioning

confidence: 99%

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Butler¹,

D’Angelo²,

Perrin³

et al. 2023

JMIR Res Protoc

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Background Poor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions. Objective This trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep. Methods Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants’ ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants’ self-reported sleep quality and duration and Fitbit tracker–measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection. Results As of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023. Conclusions Evaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research—is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board. Trial Registration ClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188 International Registered Report Identifier (IRRID) DERR1-10.2196/45313

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“…Personalized trials are becoming more commonplace with recent examples including studying fatigue, depression, and back pain. [21][22][23] The objective of this study was to assess the feasibility and acceptability of a randomized personalized trial that serially delivered four BCTs, one for each 2-week period, to promote low-intensity PA (walking) in middle-aged and older adults. Wearable technology and smartphone messaging were employed to facilitate completely remote delivery of the study.…”

Section: Introductionmentioning

confidence: 99%

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults’ Physical Activity

Friel,

Goodwin,

Robles

et al. 2023

Preprint

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Purpose To test the feasibility of a remotely-delivered intervention to increase low-intensity physical activity (walking) in middle-aged and older adults. Design This study used a Personalized (N-of-1) trial design. Setting This study took place at a major healthcare system from November 2021 to February 2022. Subjects Sixty adults (45–75 years, 92% female, 80% white) were recruited. Intervention A 10-week study comprising a 2-week baseline, followed by four 2-week periods where 4 Behavior Change Techniques (BCTs) - self-monitoring, goal setting, action planning and feedback - were delivered one at a time in random order. Measures Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials. Results Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased. Conclusions Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results.

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A Series of Virtual Interventions for Chronic Lower Back Pain: A Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Cited by 10 publications

References 47 publications

Personalized Feedback for Personalized Trials: Construction of Summary Reports for Participants in a Series of Personalized Trials for Chronic Lower Back Pain

Personalized Feedback for Personalized Trials: Construction of Summary Reports for Participants in a Series of Personalized Trials for Chronic Lower Back Pain

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults’ Physical Activity

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