Adherence, Medication, Gout, Lupus Erythematosus, Systemic, Rheumatic Diseases
Conditions
Brief summary
Non-adherence to evidence-based prescription medications results in preventable morbidity and mortality for middle-aged and older adults. Taking medications intended for daily use, like those to prevent or treat chronic conditions, is a repetitive action that has great similarity with other behaviors that must be performed consistently, such as regular exercise, healthy eating, and hand washing. In these cases, people who act consistently do so out of habit. The repetition-cue-reward model proposes that habit formation has three central components: behavioral repetition, associated context cues, and rewards. This model has obvious applicability to the daily repetitive activity of medication-taking but has not been tested for this behavior nor adapted as an intervention for patients in real-world care settings. The goal of this pilot study is to evaluate the feasibility and effectiveness of using the repetition-cue-reward model of healthy habit formation to improve medication adherence in patients with arthritis and other rheumatic diseases.
Detailed description
Non-adherence to evidence-based prescription medications results in preventable morbidity and mortality for middle-aged and older adults. Taking medications intended for daily use, like those to prevent or treat chronic conditions, is a repetitive action that has great similarity with other behaviors that must be performed consistently, such as regular exercise, healthy eating, and hand washing. In these cases, people who act consistently do so out of habit. The repetition-cue-reward model proposes that habit formation has three central components: behavioral repetition, associated context cues, and rewards. This model has obvious applicability to the daily repetitive activity of medication-taking but has not been tested for this behavior nor adapted as an intervention for patients in real-world care settings. The goal of this pilot study is to evaluate the feasibility and effectiveness of using the repetition-cue-reward model of healthy habit formation to improve medication adherence in patients with arthritis and other rheumatic diseases. This pilot study will be a 3-arm parallel randomized pragmatic trial comparing medication adherence for adults over 18 years old with arthritis, lupus, or gout who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of three arms for the duration of the study period. Patients in the first intervention arm will choose an event-based cue and receive daily reminder text messages reminding them of their cue. Patients in the second intervention arm will start by establishing their cue and having the donation made, but only those who show no improvement in adherence after 6 weeks will start receiving the text messages. In both interventions arms, a donation will be made to a local charity every time they take their medication. Patients in the control arm will not receive any intervention (but will receive pill bottles to monitor their adherence). Our outcomes of interest will be medication adherence, as measured by electronic pill bottles.
Interventions
BEHAVIORALCue-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.
BEHAVIORALCue-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.
Sponsors
National Institute on Aging (NIA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* English-speaking patients * receiving their care at a Brigham and Women's Hospital-affiliated rheumatology practice * \>=18 years of age * with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or gout * prescribed \>=1 oral medication for this disease for \>=4 months. * for patients with gout, had a uric acid level checked in the prior 18 months and the most recent level is \>6. * for patients with SLE, their most recent c-reactive protein level collected in the past 18 months must be \>10. * currently have a smartphone with a data plan or WiFi at home * willing and able to set up the platform and adhere to study procedures * either not currently using a pillbox or willing to use electronic pill bottles (EDMs) for diabetes medications for the duration of the study
Exclusion criteria
* Pregnant women * Incarcerated individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Medication Adherence | 18 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Uric Acid Level From Baseline | 18 weeks | Change in uric acid level from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence). | 18 |
| 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. | 18 |
| 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. | 20 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
| Overall Study | Withdrew after randomization but prior to intervention | 1 | 3 | 2 |
Baseline characteristics
| Characteristic | Control | Total | Adaptive Intervention | Non-adaptive Intervention |
|---|---|---|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 12.5 | 55.6 years STANDARD_DEVIATION 12.6 | 60.2 years STANDARD_DEVIATION 11.8 | 50.7 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 52 Participants | 19 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 44 Participants | 17 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 11 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 45 Participants | 15 Participants | 14 Participants |
| Uric Acid Level | 7.07 mg/dL STANDARD_DEVIATION 0.9 | 7.47 mg/dL STANDARD_DEVIATION 1.55 | 7.43 mg/dL STANDARD_DEVIATION 1.06 | 7.92 mg/dL STANDARD_DEVIATION 2.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 20 |
| serious Total, serious adverse events | 1 / 18 | 2 / 18 | 3 / 20 |
Outcome results
Primary
Rate of Medication Adherence
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.
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Rate of Medication Adherence | 0.76 percentage of doses taken | Standard Deviation 0.26 |
| Non-adaptive Intervention | Rate of Medication Adherence | 0.79 percentage of doses taken | Standard Deviation 0.23 |
| Adaptive Intervention | Rate of Medication Adherence | 0.83 percentage of doses taken | Standard Deviation 0.18 |
p-value: 0.7895% CI: [-0.16, 0.12]Generalized linear models
p-value: 0.7995% CI: [-0.1, 0.13]Generalized linear models
Secondary
Change in Uric Acid Level From Baseline
Change in uric acid level from baseline
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Uric Acid Level From Baseline | -1.21 milligrams per deciliter (mg/dL) | Standard Deviation 1.31 |
| Non-adaptive Intervention | Change in Uric Acid Level From Baseline | -1.13 milligrams per deciliter (mg/dL) | Standard Deviation 1.66 |
| Adaptive Intervention | Change in Uric Acid Level From Baseline | -0.55 milligrams per deciliter (mg/dL) | Standard Deviation 1.88 |
p-value: 0.2295% CI: [-0.28, 1.22]Generalized linear models
p-value: 0.2495% CI: [-0.33, 1.26]Generalized linear models