Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Participants acceptability: short customized survey |
Participants' acceptability/satisfaction will be assessed using a short customized survey. The survey will include 8 questions with options ranging from strongly agree to strongly disagree for five questions and ranging from satisfaction to dissatisfaction for the remainder 3 questions. Each question will be evaluated individually. |
T=0 to 3 months |
|
Primary |
Evaluate the dropout among participants |
Number of participants dropped out from time of randomization. Dropout is defined as missing two follow up assessments. |
T=0 to 3 months |
|
Primary |
Enrollment percentage of eligible participants |
PI will evaluate the percentage of participants that were enrolled after the 1 week run in period. |
Baseline to T=0 |
|
Primary |
Percentage of time wristband worn by participants |
PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours. |
T=0 to one week |
|
Primary |
Percentage of time wristband worn by participants |
PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours. |
from one week to two weeks |
|
Primary |
Percentage of time wristband worn by participants |
PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours. |
from two week to three weeks |
|
Primary |
Participants satisfaction: short customized survey |
Participants' acceptability/satisfaction will be assessed using a short customized survey. The survey will be a Likert scale and will include 2 questions with options ranging from satisfied to dissatisfied (with 1 indicating satisfaction and 5 indicating dissatisfaction). One other question is a likert scale with options ranging from 1-3 with 1 indicating the device was very useful and 3 indicating the device was not at all useful. A higher score indicates a worse outcome (less satisfaction with the device). Each question will be evaluated individually. |
T=0 to 3 months |
|
Secondary |
Percentage of participants that made a quit attempt |
PI will evaluate the percentage of participants that made a quit attempt as defined by absence of smoking for more than 24 hours in the previous seven days. This will be assessed through the follow up survey given at various intervals. |
From T=0 to one week |
|
Secondary |
Percentage of participants that made a quit attempt |
PI will evaluate the percentage of participants that made a quit attempt as defined by absence of smoking for more than 24 hours in the previous seven days. This will be assessed through the follow up survey given at various intervals. |
From T=1 week to 2 weeks |
|
Secondary |
Percentage of participants that made a quit attempt |
PI will evaluate the percentage of participants that made a quit attempt as defined by absence of smoking for more than 24 hours in the previous seven days. This will be assessed through the follow up survey given at various intervals. |
From T= 2 weeks to 3 weeks |
|
Secondary |
Average Degree of smoking reduction |
PI will evaluate the average percentage of smoking reduction. This will be quantified by the average number of cigarettes smoked at baseline compared to the average number of cigarettes smoked at 3 months. This will be assessed via the "Follow survey". |
From baseline to 3 months |
|
Secondary |
Percentage of participants who had cessation of smoking. |
P will evaluate the percentage of participants who had cessation of smoking, as defined by the absence of smoking in the previous 30 days. This will be evaluated by the "Three month Questionnaire" |
T=0 to T= 3 weeks |
|
Secondary |
Before and after smoking self-efficacy score |
The PI will evaluate the self-efficacy of the participant as evaluated by the "Baseline Smoking self-efficacy scale Short form". There are 9 questions which will assess the confidence of the participant to not smoke.The investigators will use Likert scale for each question which assesses the participants confidence to "not smoke" in various circumstances. The answers range from 1 to 5 with 1 indicating "not at all confident" and 5 indicating "extremely confident". The overall score for each participant will be calculated by sum of scores from all items. This score for individual subscales will be calculated by sum item scores so that the total score will range from 9 to 45, with a lower score indicating a worse outcome i.e. less confidence to not smoke). |
Baseline to 3 months |
|
Secondary |
Stage of change |
The investigators will use Likert scale for each question to evaluate the motivation to change. A score of 1 indicates that the participant has no intention to quit smoking and the score of 5 indicates that the participant is highly motivated. Evaluate the initial stage of change of the participant as judged by "Screening Questionnaire, Stage of Change". There is only 1 question. |
From baseline until 3 months |
|