An interventional study of Cue-Reward Intervention and Cue-Reward Intervention with possible intensification in Rheumatic Diseases, Gout and Adherence, Medication, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
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.
380 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.
This study's enrollment of 62 is below the median of 73 across 213 interventional studies indexed under Rheumatic Diseases.
Browse Rheumatic Diseases studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
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.
Behavioral: Cue-Reward 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.
Behavioral: Cue-Reward Intervention with possible intensification
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.
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
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
Change in Uric Acid Level From Baseline
Change in uric acid level from baseline
Time frame: 18 weeks
| Milestone | Control | Non-adaptive Intervention | Adaptive Intervention |
|---|---|---|---|
| Started | 19 | 21 | 22 |
| Completed | 17 | 17 | 18 |
| Not completed | 2 | 4 | 4 |
| Withdrew: Withdrew after randomization but prior to intervention | 1 | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 1 |
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.
| percentage of doses taken | Control | Non-adaptive Intervention | Adaptive Intervention |
|---|---|---|---|
| Rate of Medication Adherence | 0.76 ± 0.26 | 0.79 ± 0.23 | 0.83 ± 0.18 |
Change in uric acid level from baseline
| milligrams per deciliter (mg/dL) | Control | Non-adaptive Intervention | Adaptive Intervention |
|---|---|---|---|
| Change in Uric Acid Level From Baseline | -1.21 ± 1.31 | -1.13 ± 1.66 | -0.55 ± 1.88 |
Collected over Adverse events were collected through the entire trial period of 18 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) |
| Non-adaptive Intervention | 0/18 (0%) | 2/18 (11.1%) | 0/18 (0%) |
| Adaptive Intervention | 0/20 (0%) | 3/20 (15%) | 0/20 (0%) |
| Event | Control | Non-adaptive Intervention | Adaptive Intervention |
|---|---|---|---|
| Kidney transplantSurgical and medical procedures | 0/18 | 1/18 | 0/20 |
| AppendectomySurgical and medical procedures | 1/18 | 0/18 | 0/20 |
| Hospitalization for colostomy leakGastrointestinal disorders | 0/18 | 1/18 | 0/20 |
| Ileostomy reversalSurgical and medical procedures | 0/18 | 1/18 | 0/20 |
| Hospitalization for congestive heart failureCardiac disorders | 0/18 | 0/18 | 1/20 |
| Hospitalization for fall-related complicationsInjury, poisoning and procedural complications | 0/18 | 0/18 | 1/20 |
| Hospitalization for secondary hypertensionVascular disorders | 0/18 | 0/18 | 1/20 |
We consented and randomized 62 participants in total (see Results Participant Flow). However, 6 participants never started the trial, so they are not included in the Baseline Analysis Population. Thus, the baseline population represented here are the 56 participants who consented and initiated the trial. Those 6 participants are reflected in the Results Participant Flow under withdrawal reason "withdrew after randomization but prior to intervention."
| Age, Continuous(years) | Control | Non-adaptive Intervention | Adaptive Intervention | Total |
|---|---|---|---|---|
| Mean | 54.8 ± 12.5 | 50.7 ± 12.4 | 60.2 ± 11.8 | 55.6 ± 12.6 |
| Sex: Female, Male(Participants) | Control | Non-adaptive Intervention | Adaptive Intervention | Total |
|---|---|---|---|---|
| Female | 2 | 4 | 5 | 11 |
| Male | 16 | 14 | 15 | 45 |
| Ethnicity (NIH/OMB)(Participants) | Control | Non-adaptive Intervention | Adaptive Intervention | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 1 | 4 |
| Not Hispanic or Latino | 17 | 16 | 19 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Non-adaptive Intervention | Adaptive Intervention | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 2 | 9 |
| White | 14 | 13 | 17 | 44 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Uric Acid Level(mg/dL) | Control | Non-adaptive Intervention | Adaptive Intervention | Total |
|---|---|---|---|---|
| Mean | 7.07 ± 0.90 | 7.92 ± 2.31 | 7.43 ± 1.06 | 7.47 ± 1.55 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Aug 2021 to primary completion in Sep 2022, 13 months.
Results were first posted in Oct 2023, 1 year after primary completion.
Of 102 non-industry interventional studies with no phase under Rheumatic Diseases, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's 13 months is below that.
Counting every sponsor, half of 106 studies reached it within 21 months; a quarter within 8 and three quarters within 43.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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