Trial Outcomes & Findings for Project SMART Automated Pillbox Study (NCT NCT04418076)
NCT ID: NCT04418076
Last Updated: 2023-05-15
Results Overview
Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Week 12
Results posted on
2023-05-15
Participant Flow
Participants were recruited from two sites--New Haven and Hartford, CT. Recruitment started in June 2017 and concluded in January 1st 2020.
This study required participants to change their pharmacy for delivery of HIV medication , so that the medication blister pack could be inserted into the TowerView smart pillbox. In some cases, participants who had severe opioid use disorder were prevented by their provider from participating in this study; they prefer close monitoring. Other factors preventing participants from continuing included co-morbidities (cancer, severe SUD), incarceration, and difficulty with transportation.
Participant milestones
| Measure |
No Feedback
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
16
|
23
|
|
Overall Study
9 Participants Had Complete Lab Results at 16 Weeks
|
1
|
3
|
4
|
1
|
|
Overall Study
57 Participants Completed 12 Weeks
|
15
|
15
|
11
|
16
|
|
Overall Study
COMPLETED
|
13
|
15
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
6
|
Reasons for withdrawal
| Measure |
No Feedback
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Overall Study
Dropped out after receiving pillbox and phone
|
2
|
0
|
2
|
3
|
Baseline Characteristics
Project SMART Automated Pillbox Study
Baseline characteristics by cohort
| Measure |
No Feedback
n=19 Participants
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
n=20 Participants
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
n=16 Participants
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
n=23 Participants
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.91 years
STANDARD_DEVIATION 7.70 • n=93 Participants
|
54.78 years
STANDARD_DEVIATION 6.81 • n=4 Participants
|
51.45 years
STANDARD_DEVIATION 6.45 • n=27 Participants
|
55.94 years
STANDARD_DEVIATION 6.35 • n=483 Participants
|
54.65 years
STANDARD_DEVIATION 6.95 • n=36 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
39 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Transgender (male to female)
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Transgender (female to male)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Puerto Rican
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Health literacy
|
4.04 units on a scale
STANDARD_DEVIATION .99 • n=93 Participants
|
3.92 units on a scale
STANDARD_DEVIATION .92 • n=4 Participants
|
3.92 units on a scale
STANDARD_DEVIATION .85 • n=27 Participants
|
3.86 units on a scale
STANDARD_DEVIATION 1.02 • n=483 Participants
|
3.93 units on a scale
STANDARD_DEVIATION .94 • n=36 Participants
|
|
Mental health (CESD-D10)
|
10.89 units on a scale
STANDARD_DEVIATION 6.67 • n=93 Participants
|
9.80 units on a scale
STANDARD_DEVIATION 7.13 • n=4 Participants
|
9.56 units on a scale
STANDARD_DEVIATION 6.18 • n=27 Participants
|
11.43 units on a scale
STANDARD_DEVIATION 7.20 • n=483 Participants
|
10.50 units on a scale
STANDARD_DEVIATION 6.77 • n=36 Participants
|
|
Alcohol screening AUDIT C
|
5.50 units on a scale
STANDARD_DEVIATION 3.09 • n=93 Participants
|
3.46 units on a scale
STANDARD_DEVIATION 3.13 • n=4 Participants
|
5.10 units on a scale
STANDARD_DEVIATION 3.64 • n=27 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 2.88 • n=483 Participants
|
4.45 units on a scale
STANDARD_DEVIATION 3.17 • n=36 Participants
|
|
Presence of cocaine use disorder
Yes
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Presence of cocaine use disorder
No
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Week 12Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
Outcome measures
| Measure |
No Feedback
n=15 Participants
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
n=15 Participants
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
n=11 Participants
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
n=16 Participants
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
|---|---|---|---|---|
|
Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
|
91.07 percentage of times pills taken
Standard Deviation 25.58
|
96.00 percentage of times pills taken
Standard Deviation 12.98
|
99.82 percentage of times pills taken
Standard Deviation .60
|
94.81 percentage of times pills taken
Standard Deviation 13.48
|
PRIMARY outcome
Timeframe: Week 16This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.
Outcome measures
| Measure |
No Feedback
n=13 Participants
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
n=15 Participants
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
n=12 Participants
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
n=17 Participants
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
|---|---|---|---|---|
|
Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)
|
96.31 percentage of times pills taken
Standard Deviation 7.49
|
93.00 percentage of times pills taken
Standard Deviation 25.76
|
92.75 percentage of times pills taken
Standard Deviation 21.53
|
93.24 percentage of times pills taken
Standard Deviation 24.15
|
SECONDARY outcome
Timeframe: End of intervention (Week 12)Population: If there is a change from viral suppression or not viral suppression to maximum viral suppression between baseline and intervention end date. Maximum viral suppression is \<20, viral suppression is \<200, not viral suppression is \>200 copies/ML. Only 26 participants whose labs are complete. Thus we were only able to analyze this outcome on 26 participants.
HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.
Outcome measures
| Measure |
No Feedback
n=8 Participants
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
n=10 Participants
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
n=8 Participants
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
|---|---|---|---|---|
|
Changes in HIV 1 RNA, QN PCR (Copies/ML)
Changed to maximum viral suppression
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Changes in HIV 1 RNA, QN PCR (Copies/ML)
Viral load decreased but not achieve max viral suppression
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Changes in HIV 1 RNA, QN PCR (Copies/ML)
Viral load increase
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Changes in HIV 1 RNA, QN PCR (Copies/ML)
No change and remained max suppression
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Changes in HIV 1 RNA, QN PCR (Copies/ML)
No change and remained viral suppression or no viral suppression
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and End of intervention (Week 12)Population: 18 lab results were missing or lost and not available. 60 participants submitted their CD4 data (summarized here) vs. 57 participants completed all data measures at week 12.
CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.
Outcome measures
| Measure |
No Feedback
n=14 Participants
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
|
Automated Feedback
n=15 Participants
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Group B\_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
|
Automated Feedback + Clinician Feedback
n=14 Participants
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Group C\_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
|
Automated Feedback + Social Network Feedback
n=17 Participants
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Group D\_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
|
|---|---|---|---|---|
|
Percent Change in CD4 Count From Baseline to Week 12
|
27.00 percentage of CD4 (helper cells)
Standard Deviation 13.33
|
26.09 percentage of CD4 (helper cells)
Standard Deviation 12.75
|
28.8 percentage of CD4 (helper cells)
Standard Deviation 9.96
|
30.81 percentage of CD4 (helper cells)
Standard Deviation 6.56
|
SECONDARY outcome
Timeframe: up to End of the study (week 16)Population: These data were not collected due to changes in the research plan.
Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).
Outcome measures
Outcome data not reported
Adverse Events
No Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Automated Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Automated Feedback + Clinician Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Automated Feedback + Social Network Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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