Neurofibroma, Plexiform, Neurofibromatosis 1
Conditions
Keywords
Plexiform Neurofibromas, Medication Event Monitoring Systems, Oral Medication
Brief summary
Background: Neurofibromatosis type 1 (NF1) is a genetic disorder. It has a broad variety of effects on the body. Up to half of people with NF1 get plexiform neurofibromas (PNs). These are benign tumors. But they can have serious effects like pain and disfigurement. To treat PNs, a person may have to take medicine every day for a long period of time. Researchers think that it will be important for people to take the medicine regularly for it to work. They want to study how well people with NF1 follow their treatment plan for PNs. Objective: To study how often people with neurofibromatosis type 1 take medicine that has been prescribed to them for treating plexiform neurofibromas. Eligibility: People ages 3-59 already enrolled in an NF1 clinical trial Design: Participants will need access to the internet to do the study activities. Parents or caregivers will do some study activities for child participants. Participants will complete 5 questionnaires. They will take about 20 minutes total. The topics will be: Demographic data Recent life events How much pain interferes with daily life Ability to focus and pay attention to tasks Emotional distress or depression Participants will mark down every time they take a dose of the medicine in their clinical trial. They will use a form the researchers give them. The pill bottles they get in their trial will have a chip in the cap that will record when it is opened. Participants will keep a daily diary of their medicine. Their pills will be counted at clinical trial visits. Participants may have more short questionnaires. They may have interviews by phone or video.
Detailed description
Background: * Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in 3,500 individuals and is associated with a broad variety of symptoms and physical findings. * Plexiform neurofibromas (PN) are histologically benign tumors which occur in 25-50% of patients with NF1 and can lead to significant morbidity. * Oral therapeutic options for the treatment of plexiform neurofibromas are being actively developed, however early clinical data indicate that prolonged treatment over the course of months to years will likely be needed to maintain clinical efficacy * Long-term medication adherence is an ongoing challenge for patients with many types of chronic illness, and clinical experience makes us strongly suspect patients with NF1 will likely have this issue as well. * In other diseases, such as human immunodeficiency virus (HIV) and Acute Lymphoblastic Leukemia, decreased medication adherence has been associated with poorer clinical outcomes, and this may be the case for NF1 as well. * The medication event monitoring systems (MEMS\^TM) uses a computerized method of tracking the dates and times of a pill bottle being opened and has been shown to be a more accurate measure of medication adherence than patient diaries or pill counts in other patient populations. * Assessing medication adherence over time in this unique population will be essential for assessing any impact on medical outcomes, identifying potential behavioral interventions, and targeting patients most at risk for nonadherence moving forward. Objective: \- To establish the feasibility of using MEMS\^TM to monitor medication adherence in the NF1 population Eligibility: * Subjects must have a diagnosis of NF1 and be between 3 and 59 years of age * Participants must be enrolled on a clinical trial for an oral medication in pill (tablet or capsule) form directed at the treatment of plexiform neurofibroma(s) Design: * This single-site, longitudinal study will recruit children and adults with NF1 who are currently enrolled in a treatment protocol for a drug targeting PN volume reduction. * MEMS\^TM caps will be used to monitor adherence over time along with patient diaries and pill counts. * Patients with MEMS\^TM cap data indicating \<90% adherence at any study visit (typically across 3 - 6 cycles) will be administered a measure assessing barriers to adherence electronically and will be interviewed to evaluate what factors might contribute to decreased medication adherence and what potential interventions they consider useful.
Interventions
BEHAVIORALMedication Event Monitoring System (MEMS^TM)
A computerized method of tracking the dates and times of a pill bottle being opened.
OTHERQuestionnaires
Adult and pediatric participants completed a series of questionnaires to assess medication adherence, demographics, life events, and barriers to adherence.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: Inclusion Criteria for Patient * Patients must be between 3 and 59 years of age at the time of the baseline assessment. * Patients must be enrolled on a neurofibromatosis Type 1 (NF1) clinical trial for an oral medication directed at the treatment of plexiform neurofibroma(s) (enrollment on this study to occur ideally within 1st cycle) Patients must have regular access to a computer or electronic device (e.g., smartphone, tablet) with internet access. * Must have a parent or adult primary caregiver willing to participate in the study. * Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. * Subjects must be able to read and comprehend the English language. Inclusion Criteria for Parents or Caregivers * Must be a parent or primary caregiver of a child (or if applicable adult patient) of diagnosed with NF1 and enrolled on a clinical trial for oral medication. * Must have a child (or if applicable adult patient) willing to participate in the study * Must have regular access to a computer or electronic device (e.g., smartphone, tablet) with internet access. * Must be able to speak and understand English. * Ability of subject to understand and the willing to sign a written informed consent document.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Number of Cycles Monitored for Participants From the Medication Event Monitoring System (MEMS^TM) | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | To monitor medication adherence the medication event monitoring system (MEMSTM) was used to track the dates and times a pill bottle was opened. We calculated the median number of cycles monitored for all patients. |
| Proportion of Enrolled Participants for Which we Are Able to Collect Data From the Medication Event Monitoring Systems (MEMS^TM) System for Two or More Cycles of Treatment (Target = 75%) | Two cycles, approximately 56 days | The proportion of enrolled participants are reported for individuals who had two full cycles of data recorded by the medication event monitoring systems (MEMS\^TM) system. To monitor medication adherence the medication event monitoring system (MEMSTM) used to track the dates and times a pill bottle was opened. At least 2 cycles of medication adherence are considered a success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), an range of approximately 112 days to 504 days | A repeated-measures ANOVA was used to compare three adherence assessment methods over time. The medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. Pill count was used to assess how many pills were returned at each restaging visit compared to the number that should be returned if all medication was taken as prescribed. The daily diary was completed by participants, documenting date and timing of doses. The mean of these numbers was computed across groups of cycles (1 cycle = 28 days) 1-4, 5-8, 9-12 and 13-18 for the MEMS\^TM, Pill Count, and Daily Diary. |
| Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and age, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4, cycles 5-8, cycles 9-12, and cycles 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. |
| Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap for years of education, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Number of years of education was collected through participant self-report and was a continuous variable. |
| Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | Outcome measures correlations between 2 variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap & PROMIS Pain Interference T- Scores (Same for all PROMIS measures) Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-13hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle & dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Pain Interference raw scores transformed to T-scores for analysis (mean:50,standard deviation: 10, higher scores is more pain interference, T of 55 is cutoff-mild pain interference). |
| Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Depression Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Depression raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more depression symptoms, T of 55 is the cut off for mild depressive symptoms). |
| Barriers to Adherence Questionnaire | Baseline and follow-up (between cycles 8 and 12; or after cycle 18/when taken off of study (range of 224-504 days) | Participants completed a barriers questionnaire to assess barriers most frequently endorsed on the questionnaire. The questionnaire focused on any medication adherence issues during the trial (e.g., missed doses). Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that caused them to miss a dose of medication. Participants were also able to provide additional reasons for missing medication that were not on the form. |
| Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | The outcome measures Spearman correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data. Barriers to adherence was calculated by summing the number of barriers for each participant at follow-up. Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that apply to them. |
| Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | To assess the relationship between the adherence method MEMS\^TM cap and stressful life events (i.e., the number of stressful life events endorsed in the Life Events Checklist), Spearman correlation was used. Participants complete a 22-item questionnaire to report stressful events that impact medication adherence. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data. |
| Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | To assess the relationship between the adherence method MEMS\^TM cap and rating of overall stress, Spearman correlation was used. Participants complete a 1-item question asking them to rate their stress from 0 - 10, with higher numbers being more stressed. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data. |
| Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Cognitive Interference Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Cognitive Interference raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more cognitive interference, T of 60 represents mild interference). |
| Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data | Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days | To monitor medication adherence the medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. The mean of these numbers was computed across groups of cycles 1-4, 5-8, 9-12 and 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Higher number is better adherence. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events | Baseline to cycle 18 (end of study), approximately 504 days (1.38 years) | Here is the number of participants with serious and/or non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Pre-assignment details
No pediatric participants were enrolled on this trial.
Participants by arm
| Arm | Count |
|---|---|
| Adult Participants (18+ Years) Questionnaires and use of the medication event monitoring system (MEMS\^TM)
Participants must take an oral medication in pill (tablet or capsule) form directed at the treatment of plexiform neurofibroma(s).
Medication Event Monitoring System (MEMS\^TM) caps will be used to monitor adherence over time along with patient diaries and pill counts.
Medication Event Monitoring System (MEMS\^TM): A computerized method of tracking the dates and times of a pill bottle being opened. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Adult Participants (18+ Years) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 34.36 years STANDARD_DEVIATION 8.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Median Number of Cycles Monitored for Participants From the Medication Event Monitoring System (MEMS^TM)
To monitor medication adherence the medication event monitoring system (MEMSTM) was used to track the dates and times a pill bottle was opened. We calculated the median number of cycles monitored for all patients.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants were analyzed because 1 participant's cap malfunctioned, so no data was collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adult Participants (18+ Years) | Median Number of Cycles Monitored for Participants From the Medication Event Monitoring System (MEMS^TM) | 16 Cycles |
Primary
Proportion of Enrolled Participants for Which we Are Able to Collect Data From the Medication Event Monitoring Systems (MEMS^TM) System for Two or More Cycles of Treatment (Target = 75%)
The proportion of enrolled participants are reported for individuals who had two full cycles of data recorded by the medication event monitoring systems (MEMS\^TM) system. To monitor medication adherence the medication event monitoring system (MEMSTM) used to track the dates and times a pill bottle was opened. At least 2 cycles of medication adherence are considered a success.
Time frame: Two cycles, approximately 56 days
Population: 11/12 participants were analyzed because 1 participant's cap malfunctioned, so no data was collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Participants (18+ Years) | Proportion of Enrolled Participants for Which we Are Able to Collect Data From the Medication Event Monitoring Systems (MEMS^TM) System for Two or More Cycles of Treatment (Target = 75%) | 0.9167 Proportion of participants |
Secondary
ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count
A repeated-measures ANOVA was used to compare three adherence assessment methods over time. The medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. Pill count was used to assess how many pills were returned at each restaging visit compared to the number that should be returned if all medication was taken as prescribed. The daily diary was completed by participants, documenting date and timing of doses. The mean of these numbers was computed across groups of cycles (1 cycle = 28 days) 1-4, 5-8, 9-12 and 13-18 for the MEMS\^TM, Pill Count, and Daily Diary.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), an range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8 . 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count | Cycles 1-4 | 11.944 ANOVA F-Value |
| Adult Participants (18+ Years) | ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count | Cycles 5-8 | 7.770 ANOVA F-Value |
| Adult Participants (18+ Years) | ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count | Cycles 9-12 | 6.670 ANOVA F-Value |
| Adult Participants (18+ Years) | ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count | Cycles 13-18 | 6.333 ANOVA F-Value |
p-value: 0.006ANOVA
p-value: 0.021ANOVA
p-value: 0.034ANOVA
p-value: 0.04ANOVA
Secondary
Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data
To monitor medication adherence the medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. The mean of these numbers was computed across groups of cycles 1-4, 5-8, 9-12 and 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Higher number is better adherence.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants (18+ Years) | Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data | Cycles 1-4 | 83.39 percent | Standard Deviation 16.71 |
| Adult Participants (18+ Years) | Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data | Cycles 5-8 | 87.01 percent | Standard Deviation 14.62 |
| Adult Participants (18+ Years) | Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data | Cycles 9-12 | 84.77 percent | Standard Deviation 15.44 |
| Adult Participants (18+ Years) | Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data | Cycles 13-18 | 79.68 percent | Standard Deviation 20.85 |
Secondary
Barriers to Adherence Questionnaire
Participants completed a barriers questionnaire to assess barriers most frequently endorsed on the questionnaire. The questionnaire focused on any medication adherence issues during the trial (e.g., missed doses). Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that caused them to miss a dose of medication. Participants were also able to provide additional reasons for missing medication that were not on the form.
Time frame: Baseline and follow-up (between cycles 8 and 12; or after cycle 18/when taken off of study (range of 224-504 days)
Population: Six participants were given the barriers to adherence questionnaire at baseline due to error. One participant was not given the barriers to adherence questionnaire at follow-up due to error, so only 11/12 participants had this at follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Away from home | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Busy with other things | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Forgot | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Had too many pills to take | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Other reason | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Wanted to avoid having side effects | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Did not want others to see taking medication | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Change in daily routine | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Too tired or slept through dose time | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Felt sick or ill | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Felt sad or stressed out | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Had problem taking medicine with clear liquid | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Had difficulty swallowing pills | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Ran out of pills | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Didn't like taste of medicine | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Didn't think medicine was working | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at baseline: Didn't feel like it/Needed a break | 0 Participants |
| Adult Participants (18+ Years) | Barriers to Adherence Questionnaire | Most commonly reported barrier at follow-up: Forgetting | 6 Participants |
Secondary
Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress
To assess the relationship between the adherence method MEMS\^TM cap and rating of overall stress, Spearman correlation was used. Participants complete a 1-item question asking them to rate their stress from 0 - 10, with higher numbers being more stressed. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8 . 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress | Cycles 1-4 | -0.638 Correlation coefficient |
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress | Cycles 5-8 | -0.361 Correlation coefficient |
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress | Cycles 9-12 | -0.407 Correlation coefficient |
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress | Cycles 13-18 | -0.180 Correlation coefficient |
p-value: 0.03595% CI: [-0.899, -0.041]Spearman correlation
p-value: 0.30695% CI: [-0.815, 0.367]Spearman correlation
p-value: 0.31795% CI: [-0.87, 0.438]Spearman correlation
p-value: 0.6795% CI: [-0.795, 0.0617]Spearman correlation
Secondary
Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist
To assess the relationship between the adherence method MEMS\^TM cap and stressful life events (i.e., the number of stressful life events endorsed in the Life Events Checklist), Spearman correlation was used. Participants complete a 22-item questionnaire to report stressful events that impact medication adherence. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist | Cycles 1-4 | -0.035 Correlation coefficient |
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist | Cycles 5-8 | 0.227 Correlation coefficient |
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist | Cycles 9-12 | 0.179 Correlation coefficient |
| Adult Participants (18+ Years) | Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist | Cycles 13-18 | 0.041 Correlation coefficient |
p-value: 0.91995% CI: [-0.634, 0.591]Spearman correlation
p-value: 0.52895% CI: [-0.487, 0.759]Spearman correlation
p-value: 0.67295% CI: [-0.618, 0.794]Spearman correlation
p-value: 0.92395% CI: [-0.697, 0.737]Spearman correlation
Secondary
Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and age, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4, cycles 5-8, cycles 9-12, and cycles 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age | Cycles 1-4 | -0.210 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age | Cycles 5-8 | 0.134 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age | Cycles 9-12 | .095 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age | Cycles 13-18 | .333 Correlation coefficient |
p-value: 0.53695% CI: [-0.729, 0.463]Spearman correlation (non-parametric)
p-value: 0.71395% CI: [-0.557, 0.715]Spearman correlation (non-parametric)
p-value: 0.82395% CI: [-0.668, 0.761]Spearman correlation (non-parametric)
p-value: 0.4295% CI: [-0.505, 0.848]Spearman correlation (non-parametric)
Secondary
Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap for years of education, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Number of years of education was collected through participant self-report and was a continuous variable.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education | Cycles 1-4 | -0.333 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education | Cycles 5-8 | -0.309 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education | Cycles 9-12 | -0.259 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education | Cycles 13-18 | -0.222 Correlation coefficient |
p-value: 0.31795% CI: [-0.785, 0.352]Spearman correlation (non-parametric)
p-value: 0.38595% CI: [-0.794, 0.416]Spearman correlation (non-parametric)
p-value: 0.53595% CI: [-0.824, 0.563]Spearman correlation (non-parametric)
p-value: 0.59795% CI: [-0.811, 0.589]Spearman correlation (non-parametric)
Secondary
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire
The outcome measures Spearman correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data. Barriers to adherence was calculated by summing the number of barriers for each participant at follow-up. Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that apply to them.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire | Cycles 1-4 | -0.576 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire | Cycles 5-8 | -0.680 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire | Cycles 9-12 | -0.835 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire | Cycles 13-18 | -0.933 Correlation coefficient |
p-value: 0.06395% CI: [-0.879, 0.056]Spearman correlation (non-parametric)
p-value: 0.03195% CI: [-0.92, -0.066]Wilcoxon (Mann-Whitney)
p-value: 0.0195% CI: [-0.971, -0.292]Spearman correlation (non-parametric)
p-value: <0.00195% CI: [-0.989, -0.652]Spearman correlation (non-parametric)
Secondary
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Cognitive Interference Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Cognitive Interference raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more cognitive interference, T of 60 represents mild interference).
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores | Cycles 1-4 | 0.293 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores | Cycles 5-8 | 0.278 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores | Cycles 9-12 | 0.229 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores | Cycles 13-18 | 0.530 Correlation coefficient |
p-value: 0.38295% CI: [-0.39, 0.768]Spearman correlation (non-parametric)
p-value: 0.43695% CI: [-0.444, 0.781]Spearman correlation (non-parametric)
p-value: 0.58695% CI: [-0.585, 0.813]Spearman correlation (non-parametric)
p-value: 0.17795% CI: [-0.302, 0.904]Spearman correlation (non-parametric)
Secondary
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Depression Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Depression raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more depression symptoms, T of 55 is the cut off for mild depressive symptoms).
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores | Cycles 1-4 | -.607 Correlation coefficients |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores | Cycles 5-8 | -0.658 Correlation coefficients |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores | Cycles 9-12 | -0.708 Correlation coefficients |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores | Cycles 13-18 | -0.878 Correlation coefficients |
p-value: 0.04895% CI: [-0.889, 0.009]Spearman correlation (non-parametric)
p-value: 0.03895% CI: [-0.914, -0.027]Spearman correlation (non-parametric)
p-value: 0.595% CI: [-0.945, 0.02]Spearman correlation (non-parametric)
p-value: 0.00495% CI: [-0.979, -0.435]Spearman correlation (non-parametric)
Secondary
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores
Outcome measures correlations between 2 variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap & PROMIS Pain Interference T- Scores (Same for all PROMIS measures) Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-13hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle & dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Pain Interference raw scores transformed to T-scores for analysis (mean:50,standard deviation: 10, higher scores is more pain interference, T of 55 is cutoff-mild pain interference).
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Population: 11/12 participants (pts) analyzed Cycles(C) 1-4. 1 pts MEMS cap malfunctioned (= 0 data across any C). 10/12 pts analyzed C5-8. 1 additional pt withdrew from the study, resulting in 0 MEMS data beginning C5. 8/12 pts analyzed C9-12 \& C13-18. 1 pt withdrew from study after C9 \& 1 failed to return their MEMS Cap. Due to battery expiration between clinic visits, at least 1C was unable to be obtained for 5pts. And 1pt had missing data due to forgetting to replace the cap on the next cycle's bottle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores | Cycles 1-4 | -.215 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores | Cycles 5-8 | 0.049 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores | Cycles 9-12 | -0.048 Correlation coefficient |
| Adult Participants (18+ Years) | Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores | Cycles 13-18 | -0.167 Correlation coefficient |
p-value: 0.52695% CI: [-0.731, 0.459]Spearman correlation (non-parametric)
p-value: 0.89495% CI: [-0.613, 0.67]Spearman correlation (non-parametric)
p-value: 0.91195% CI: [-0.74, 0.694]Spearman correlation (non-parametric)
p-value: 0.69395% CI: [-0.79, 0.626]Spearman correlation (non-parametric)
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events
Here is the number of participants with serious and/or non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Baseline to cycle 18 (end of study), approximately 504 days (1.38 years)
Population: As pre-specified by the protocol, adverse events occurring because of treatment for the underlying condition or medical treatment for pain will NOT be recorded in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adult Participants (18+ Years) | Number of Participants With Serious and/or Non-serious Adverse Events | 0 Participants |