Rheumatic DiseasesNCT04776161
Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
A study testing Cue-Reward Intervention and Cue-Reward Intervention with possible intensification in people with Rheumatic Diseases and Gout, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatic Diseases, Gout, Adherence, Medication
- What is being tested?
- Cue-Reward Intervention and Cue-Reward Intervention with possible intensification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- Pregnant women
- Incarcerated individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
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.
Read the 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.
- Being tested
- Cue-Reward Intervention, Cue-Reward Intervention with possible intensification
- Medical subject headings
- Rheumatic Diseases, Gout, Medication Adherence, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue-Reward InterventionBehavioural
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.
Cue-Reward Intervention with possible intensificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence). |
| Cue-Reward Intervention | Experimental | 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. Receives: Behavioral: Cue-Reward Intervention |
| Cue-Reward Intervention with possible intensification. | Experimental | 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. Receives: Behavioral: Cue-Reward Intervention with possible intensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Secondary outcomes (1)
Change in Uric Acid Level From Baseline
Change in uric acid level from baseline
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start2 Aug 2021
- Primary completion27 Sep 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Candace Hillary Feldman, MD, Brigham and Women's Hospital
- Investigators
- Candace H Feldman, MD, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776161
- Sponsor's protocol ID
- 2020P003826
- Other IDs
- P30AG064199-01
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2021
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fontanet CP, Choudhry NK, Wood W, Robertson T, Haff N, Oran R, Sears ES, Kim E, Hanken K, Barlev RA, Lauffenburger JC, Feldman CH. Randomised controlled trial targeting habit formation to improve medication adherence to daily oral medications in patients with gout. BMJ Open. 2021 Nov 24;11(11):e055930. doi: 10.1136/bmjopen-2021-055930.
PubMed 34819291
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
- ClinicalTrials.gov ID
- NCT04776161
- Acronym / sponsor ID
- 2020P003826
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence). |
| Cue-Reward Intervention | Experimental | Behavioral: Cue-Reward InterventionPatients 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 with possible intensification. | Experimental | Behavioral: Cue-Reward Intervention with possible intensificationPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women
- Incarcerated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue-Reward InterventionPatients 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. | Behavioural | Cue-Reward Intervention |
| Cue-Reward Intervention with possible intensificationPatients 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. | Behavioural | Cue-Reward Intervention with possible intensification. |
Primary outcome
Rate of Medication Adherence
Time frame: 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.
1 secondary outcome
Change in Uric Acid Level From Baseline
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34819291Fontanet CP, Choudhry NK, Wood W, Robertson T, Haff N, Oran R, Sears ES, Kim E, Hanken K, Barlev RA, Lauffenburger JC, Feldman CH. Randomised controlled trial targeting habit formation to improve medication adherence to daily oral medications in patients with gout. BMJ Open. 2021 Nov 24;11(11):e055930. doi: 10.1136/bmjopen-2021-055930.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace H Feldman, MD, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue-Reward Intervention and Cue-Reward Intervention with possible intensification in people with Rheumatic Diseases and Gout, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Medication Adherence (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04776161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.