Massive Individualized N-of-1 Experiments (MINEs)

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Richard L. Kravitz, MD, MSPH，University of California, Davis

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

February 1, 2019

Estimated Primary Completion Date

May 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Stress[ Time Frame: 18 days ]

How stressed are you feeling today? (single item Likert scale)

Focus[ Time Frame: 18 days ]

How focused are you feeling today? (single item Likert scale)

Happiness[ Time Frame: 18 days ]

How happy are you feeling today? (single item Likert scale)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

User burden[ Time Frame: Within 1 to 28 days of N-of-1 trial completion ]
User burden scale

Descriptive Information

Brief Title ^ICMJE

Massive Individualized N-of-1 Experiments (MINEs)

Official Title ^ICMJE

Massive Individualized N-of-1 Experiments Using HackYourHealth: A New Paradigm for Promoting Health and Well-Being

Brief Summary

The project will enroll up to 10,000 adult volunteers in individualized experiments (N-of-1 trials) designed to assess the individual-level effects of any of five interventions on three outcomes. The five interventions are: gratitude journaling, mindfulness meditation, random acts of kindness, physical activity, and laughter therapy. The three outcomes are stress, cognitive focus, and happiness. Each participant will engage in the selected activity in 3 day intervals, separated at random by 3 day intervals of usual activity, for a total of six 3-day periods (18 days).

Detailed Description

N-of-1 trials (single patient crossover experiments) are a uniquely powerful technique for estimating treatment effects in the individual. N-of-1 trials have been offered to hundreds or perhaps thousands of patients worldwide, but never at scale. HackYourHealth is a tool that supports the conduct of simple N-of-1 self-experiments to test if healthy activities that work in general (i.e., mindfulness meditation, physical activity, gratitude journaling, random acts of kindness, and laughter therapy), improve psychological well-being (stress, focus, happiness) in specific individuals. The tool supplies the experimental design, facilitates data analysis, and channels feedback to participants. The tool is flexible enough to support Massive Individualized N-of-1 Experiments (MINEs) at scale. Working with WNYC Radio in New York City, we will recruit and run 18-day N-of-1 trials up to 10,000 individuals. The purpose of this study is to conduct a formative evaluation of HackYourHealth in terms of its perceived usefulness and to explore heterogeneity in intervention response across the sample. We anticipate that the results will: 1) identify useful behavioral interventions for individual participants; 2) help to estimate generalizable treatment effects for the interventions of interest; 3) assess heterogeneity of treatment effects across subgroups; and 4) elucidate the user experience with N-of-1 trials. When complete, the study will support additional proposals designed to assess the utility of MINEs as applied to additional conditions and treatments.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Sequential Assignment
Intervention Model Description: Each participant will enroll in a personalized ("N-of-1") crossover trial.
Masking: Interventional
Masking Description:The analysis will proceed automatically without knowledge of which 3-day treatment periods were associated with one of the five interventions and which were associated with the subject's usual activities.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Choice of one of five behavioral interventions
All participants will choose one of the five intervention options.

Study Arms

Experimental: N-of-1 Trial
Multiple crossovers between one of the available intervention options (mindfulness meditation, gratitude journaling, physical activity, laughter therapy, or random acts of kindness) and usual activities

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

May 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Age 18 or over - Living anywhere in the United States - Using a smartphone - Having regular access to internet on their phone - Able to read and write in English Exclusion Criteria: There are no exclusion criteria, except that patients with pre-existing cardiovascular disease will be cautioned not to engage in new types of physical activity without consulting a physician.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Richard L. Kravitz, MD, MSPH，University of California, Davis

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Richard L Kravitz, MD, MSPH UC Davis Division of General Medicine

PRS Account

University of California, Davis

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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