Cigarette SmokingNCT06292130
Health-Kit Enabled Mobile App for Tobacco Cessation
A study testing refresh in people with Cigarette Smoking, run by Pro-Change Behavior Systems at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- refresh
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pro-Change Behavior Systems, Inc
South Kingstown, Rhode Island, 02879
About this study
Official title: FHIR-ed Up for Tobacco Cessation: 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.
- Conditions
- Cigarette Smoking
- Being tested
- refresh
- Keywords
- smoking, app
- Medical subject headings
- Cigarette Smoking, Smoking, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refreshBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| App users | Experimental | All participants will be provided with access to the intervention app (refresh). Receives: Behavioral: refresh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pretest (baseline) and Posttest (30 day follow-up)
Secondary outcomes (1)
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.
Measured: Pretest (baseline) and Posttest (30 day follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start21 Mar 2022
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, repeated measures (2 timepoints)
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sara Johnson, Pro-Change Behavior Systems
- Investigators
- Sara Johnson, Ph.D., Principal investigator, Pro-Change Behavior Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292130
- Sponsor's protocol ID
- 156588-01
- Other IDs
- 1R43HL156588-01A1
- Status last verified
- May 2025
- First submitted
- 28 Feb 2022
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FHIR-ed Up for Tobacco Cessation: Health-Kit Enabled Mobile App for Tobacco Cessation
- ClinicalTrials.gov ID
- NCT06292130
- Acronym / sponsor ID
- 156588-01
- Conditions
- Cigarette Smoking
- Keywords
- smoking, app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, repeated measures (2 timepoints)
| Arm | Type | Receives |
|---|---|---|
| App users | Experimental | Behavioral: refreshAll participants will be provided with access to the intervention app (refresh). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| refreshA 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. | Behavioural | App users |
Primary outcome
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.
1 secondary outcome
Confidence
Time frame: Pretest (baseline) and Posttest (30 day follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Johnson, Ph.D. principal investigator
Pro-Change Behavior Systems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing refresh in people with Cigarette Smoking, run by Pro-Change Behavior Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome (time frame: Pretest (baseline) and Posttest (30 day follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.