An interventional study of refresh in Cigarette Smoking, sponsored by Pro-Change Behavior Systems. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Pro-Change Behavior Systems · Not applicable, Interventional, and Treatment
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.
Pro-Change Behavior Systems is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will be provided with access to the intervention app (refresh).
Behavioral: refresh
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.
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.
Time frame: Pretest (baseline) and Posttest (30 day follow-up)
Confidence
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.
Time frame: Pretest (baseline) and Posttest (30 day follow-up)
| Milestone | App Users |
|---|---|
| Started | 51 |
| Completed | 39 |
| Not completed | 12 |
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.
| score on a scale | App Users |
|---|---|
| Pretest (baseline) | 12.7 ± 6.8 |
| Posttest (30 day follow-up) | 13.6 ± 5.6 |
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.
| score on a scale | App Users |
|---|---|
| Pretest (baseline) | 6.3 ± 2.5 |
| Posttest (30 day follow-up) | 7.6 ± 2.7 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| App Users | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | App Users |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 49 |
| >=65 years | 2 |
| Age, Continuous(years) | App Users |
|---|---|
| Mean | 47.4 ± 11.3 |
| Sex: Female, Male(Participants) | App Users |
|---|---|
| Female | 38 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | App Users |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 43 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | App Users |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 24 |
| White | 18 |
| More than one race | 2 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | App Users |
|---|---|
| United States | 51 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — A variety of peer-reviewed publications will emerge from the proposed research. At the conclusion of the study, the data will be de-identified and then made available to those requesting access, provided that they sign an agreement that the data will be used for research purposes only. Pro-Change routinely asks those requesting access to any data to sign such a form.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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