Trial Outcomes & Findings for Health-Kit Enabled Mobile App for Tobacco Cessation (NCT NCT06292130)
NCT ID: NCT06292130
Last Updated: 2025-05-16
Results Overview
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.
COMPLETED
NA
51 participants
Pretest (baseline) and Posttest (30 day follow-up)
2025-05-16
Participant Flow
Participant milestones
| Measure |
App Users
All participants will be provided with access to the intervention app (refresh).
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 electronic health record (EHR).
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|---|---|
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Overall Study
STARTED
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51
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Overall Study
COMPLETED
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39
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health-Kit Enabled Mobile App for Tobacco Cessation
Baseline characteristics by cohort
| Measure |
App Users
n=51 Participants
All participants will be provided with access to the intervention app (refresh).
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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49 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
|
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Age, Continuous
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47.4 years
STANDARD_DEVIATION 11.3 • n=5 Participants
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Sex: Female, Male
Female
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38 Participants
n=5 Participants
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
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Region of Enrollment
United States
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51 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
App Users
n=39 Participants
All participants will be provided with access to the intervention app (refresh).
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.
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|---|---|
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Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome
Pretest (baseline)
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12.7 score on a scale
Standard Deviation 6.8
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Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome
Posttest (30 day follow-up)
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13.6 score on a scale
Standard Deviation 5.6
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
App Users
n=39 Participants
All participants will be provided with access to the intervention app (refresh).
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.
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|---|---|
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Confidence
Pretest (baseline)
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6.3 score on a scale
Standard Deviation 2.5
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Confidence
Posttest (30 day follow-up)
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7.6 score on a scale
Standard Deviation 2.7
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Adverse Events
App Users
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place