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OpenTrials
Completed

NCT Number: NCT06292130

Health-Kit Enabled Mobile App for Tobacco Cessation

Tobacco use is the leading preventable cause of death in the US, contributing to more than 480,000 premature deaths each year. The Tobacco Treatment Guidelines underscore the need to offer patients who use tobacco products brief interventions that include prescriptions for proven pharmacological smoking cessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smart phone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidance and to send contextually relevant tailored behavior change nudges based on readiness to quit and electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps from the Health app (iOS) via Fast Healthcare Interoperability Resources standard Application Programming Interface (API).

This Phase I Small Business Innovation Research (SBIR) explored the effects of one such innovative health IT solution. refresh is a highly individualized tobacco cessation HealthKit enabled app that 1) implemented a full range of best practices in tailored health behavior change communications based on readiness to change; 2) provided individualized behavior change guidance based on Health app data; and 3) concisely provided data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message delivered by clinicians to reinforce and accelerate a patient's behavior change progress. This interoperability provided value to both patients and clinicians; empowered and supported successful and lasting behavior change; and enabled the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment.

Extensive end user and stakeholder input ensured that refresh was designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=51) were recruited to participate in a 30-day pilot test. Pre-post comparisons of Patient-Reported Outcomes Measurement Information System (PROMIS) measure for tobacco (psychosocial expectancies) and confidence for quitting provided preliminary data on the effects of the program. The hypothesis was that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up and greater confidence to quit smoking.

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Key information

Conditions

Cigarette Smoking Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Smoking Tauopathies Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pro-Change Behavior Systems, Inc

South Kingstown, Rhode Island, 02879, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Current cigarette smoker
  • Having an iPhone 6s or higher
  • Willing and able to download a mobile app
  • Able to read and speak English
  • Having an upcoming appointment with a participating clinician in the next 42 days

Exclusion criteria

  • Younger than 18
  • Non-smoker
  • Unable to read and speak English
  • Not having an iPhone 6s or higher
  • Not having an appointment with a participating clinician in the next 42 days

Treatment and study plan

refresh

Behavioral

A theoretically-grounded, highly individualized tobacco cessation Health-Kit enabled app. Unlike existing tobacco cessation apps, refresh: 1) implements a full range of best practices in tailored health behavior change communications; 2) individualizes messaging based on the patient's clinical context using Health app data obtained through Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interfaces (API) and behavior change constructs; and 3) provides data and key insights back to the EHR.

Primary outcomes

  1. Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome

    Time frame: Pretest (baseline) and Posttest (30 day follow-up)

    This reliable and valid 6-item assessment measures feelings of social disapproval of smoking, normative values associated with smoking, and negative beliefs about appearance when smoking (e.g., If I quit smoking I will be more in control of my life). It will be the primary outcome as it is appropriate for all smokers (ready to quit or not) and is highly correlated with interest in quitting (r=0.59). It is also correlated with recency of quit attempts. Participants respond on a 5-point Likert Scale from 0 (Not at all) to 4 (Very much). Raw scores range from a minimum of 0 to a maximum of 24, with higher scores indicating better outcomes. The reliability of the scale is 0.85.

Secondary outcomes

  1. Confidence

    Time frame: Pretest (baseline) and Posttest (30 day follow-up)

    This 3-item scale assesses an individual's confidence level to refrain from using tobacco even in difficult situations and is a leading indicator of movement to cessation. Ratings of confidence will be made on a 5-point Likert scale (1=not at all; 5=extremely confident). Raw scores range from a minimum of 3 to a maximum of 15, with higher scores indicating better outcomes.

Sponsors and collaborators

Lead sponsor

Pro-Change Behavior Systems

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

FHIR-ed Up for Tobacco Cessation: Health-Kit Enabled Mobile App for Tobacco Cessation

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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