Health-Kit Enabled Mobile App for Tobacco Cessation

NCT06292130 | Completed Results DMC

• 2 other identifiers: 156588-011R43HL156588-01A1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking

Keywords

smoking; app

Outcome Measures

Primary Outcomes (1)

• Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome

  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.

  Pretest (baseline) and Posttest (30 day follow-up)

Secondary Outcomes (1)

• Confidence

  Pretest (baseline) and Posttest (30 day follow-up)

Study Arms (1)

App users

EXPERIMENTAL

All participants will be provided with access to the intervention app (refresh).

Behavioral: refresh

Interventions

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.

App users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Pro-Change Behavior Systems, Inc

South Kingstown, Rhode Island, 02879, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Alzheimer Disease

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Sara Johnson, PhD
• Organization: Pro-Change Behavior Systems, Inc.

sjohnson@prochange.com

401.360.2980

Study Officials

• Sara Johnson, Ph.D.

  Pro-Change Behavior Systems, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-President & CEO

Model Details: Single group, repeated measures (2 timepoints)

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 4, 2024
• Study Start: March 21, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: May 16, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)