Trial Outcomes & Findings for Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial (NCT NCT04776161)
NCT ID: NCT04776161
Last Updated: 2023-10-04
Results Overview
Medication adherence will be measured as the percentage of times a patient opened the electronic pill bottle out of the number of doses prescribed for each bottle in each day, averaged across the study medications and over follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
18 weeks
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
Control
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
|
Non-adaptive Intervention
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
|
Adaptive Intervention
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
22
|
|
Overall Study
COMPLETED
|
17
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Control
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
|
Non-adaptive Intervention
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
|
Adaptive Intervention
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
|
|---|---|---|---|
|
Overall Study
Withdrew after randomization but prior to intervention
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
Baseline Characteristics
Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
Baseline characteristics by cohort
| Measure |
Control
n=18 Participants
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
|
Non-adaptive Intervention
n=18 Participants
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
|
Adaptive Intervention
n=20 Participants
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Uric Acid Level
|
7.07 mg/dL
STANDARD_DEVIATION 0.90 • n=5 Participants
|
7.92 mg/dL
STANDARD_DEVIATION 2.31 • n=7 Participants
|
7.43 mg/dL
STANDARD_DEVIATION 1.06 • n=5 Participants
|
7.47 mg/dL
STANDARD_DEVIATION 1.55 • n=4 Participants
|
PRIMARY outcome
Timeframe: 18 weeksMedication adherence will be measured as the percentage of times a patient opened the electronic pill bottle out of the number of doses prescribed for each bottle in each day, averaged across the study medications and over follow-up.
Outcome measures
| Measure |
Control
n=18 Participants
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
|
Non-adaptive Intervention
n=18 Participants
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
|
Adaptive Intervention
n=20 Participants
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
|
|---|---|---|---|
|
Rate of Medication Adherence
|
0.76 percentage of doses taken
Standard Deviation 0.26
|
0.79 percentage of doses taken
Standard Deviation 0.23
|
0.83 percentage of doses taken
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 18 weeksChange in uric acid level from baseline
Outcome measures
| Measure |
Control
n=18 Participants
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
|
Non-adaptive Intervention
n=18 Participants
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
|
Adaptive Intervention
n=20 Participants
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
|
|---|---|---|---|
|
Change in Uric Acid Level From Baseline
|
-1.21 milligrams per deciliter (mg/dL)
Standard Deviation 1.31
|
-1.13 milligrams per deciliter (mg/dL)
Standard Deviation 1.66
|
-0.55 milligrams per deciliter (mg/dL)
Standard Deviation 1.88
|
Adverse Events
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-adaptive Intervention
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Adaptive Intervention
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=18 participants at risk
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
|
Non-adaptive Intervention
n=18 participants at risk
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
|
Adaptive Intervention
n=20 participants at risk
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
|
|---|---|---|---|
|
Cardiac disorders
Hospitalization for congestive heart failure
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
|
Injury, poisoning and procedural complications
Hospitalization for fall-related complications
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
|
Surgical and medical procedures
Kidney transplant
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/20 • Adverse events were collected through the entire trial period of 18 weeks.
|
|
Surgical and medical procedures
Appendectomy
|
5.6%
1/18 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/20 • Adverse events were collected through the entire trial period of 18 weeks.
|
|
Vascular disorders
Hospitalization for secondary hypertension
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
|
Gastrointestinal disorders
Hospitalization for colostomy leak
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/20 • Adverse events were collected through the entire trial period of 18 weeks.
|
|
Surgical and medical procedures
Ileostomy reversal
|
0.00%
0/18 • Adverse events were collected through the entire trial period of 18 weeks.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected through the entire trial period of 18 weeks.
|
0.00%
0/20 • Adverse events were collected through the entire trial period of 18 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Candace Feldman, MD, MPH, ScD
Brigham and Women's Hospital
Phone: 617-525-1035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place