Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
Condition: Rheumatic Diseases; Gout; Adherence, Medication; Lupus Erythematosus, Systemic
MeSH terms: Rheumatic Diseases; Collagen Diseases; Lupus Erythematosus, Systemic
Study type: Interventional

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.
    

Intervention name(s): Cue-Reward Intervention; Cue-Reward Intervention with possible intensification
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research