Dataset Information

Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial.

ABSTRACT:

Importance

Forgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.

Objective

To compare the effect of 3 low-cost reminder devices on medication adherence.

Design, setting, and participants

This 4-arm, block-randomized clinical trial involved 53 480 enrollees of CVS Caremark, a pharmacy benefit manager, across the United States. Eligible participants were aged 18 to 64 years and taking 1 to 3 oral medications for long-term use. Participants had to be suboptimally adherent to all of their prescribed therapies (with a medication possession ratio of 30% to 80%) in the 12 months before randomization. Participants were stratified on the basis of the medications they were using at randomization: medications for cardiovascular or other nondepression chronic conditions (the chronic disease stratum) and antidepressants (the antidepressant stratum). In each stratum, randomization occurred within blocks defined by whether all of the patient's targeted medications were dosed once daily. Patients were randomized to receive in the mail a pill bottle strip with toggles, digital timer cap, or standard pillbox. The control group received neither notification nor a device. Data were collected from February 12, 2013, through March 21, 2015, and data analyses were on the intention-to-treat population.

Main outcomes and measures

The primary outcome was optimal adherence (medication possession ratio ≥80%) to all eligible medications among patients in the chronic disease stratum during 12 months of follow-up, ascertained using pharmacy claims data. Secondary outcomes included optimal adherence to cardiovascular medications among patients in the chronic disease stratum as well as optimal adherence to antidepressants.

Results

Of the 53 480 participants, mean (SD) age was 45 (12) years and 56% were female. In the primary analysis, 15.5% of patients in the chronic disease stratum assigned to the standard pillbox, 15.1% assigned to the digital timer cap, 16.3% assigned to the pill bottle strip with toggles, and 15.1% assigned to the control arm were optimally adherent to their prescribed treatments during follow-up. There was no statistically significant difference in the odds of optimal adherence between the control and any of the devices (standard pillbox: odds ratio [OR], 1.03 [95% CI, 0.95-1.13]; digital timer cap: OR, 1.00 [95% CI, 0.92-1.09]; and pill bottle strip with toggles: OR, 0.94 [95% CI, 0.85-1.04]). In direct comparisons, the odds of optimal adherence were higher with a standard pillbox than with the pill bottle strip (OR, 1.10 [95% CI, 1.00-1.21]). Secondary analyses yielded similar results.

Conclusions and relevance

Low-cost reminder devices did not improve adherence among nonadherent patients who were taking up to 3 medications to treat common chronic conditions. The devices may have been more effective if coupled with interventions to ensure consistent use or if targeted to individuals with an even higher risk of nonadherence.

Trial registration

clinicaltrials.gov Identifier: NCT02015806.

SUBMITTER: Choudhry NK

PROVIDER: S-EPMC5470369 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Poor medication adherence is common and limits the effectiveness of treatment. OBJECTIVE:To investigate how social supports, automated alerts, and their combination improve medication adherence. DESIGN:Four-arm, randomized clinical trial with a 6-month intervention. PARTICIPANTS:A total of 179 CVS health employees or adult dependents with CVS Caremark prescription coverage, a current daily statin prescription, a medication possession ratio less than 80%, and Internet access. INTERVENTIONS:Participants were randomly assigned to control, social support (partner), automated adherence alert messages (alert), or both social support and alerts (partner?+?alert). Participants in the social support arms were asked to name a medication adherence partner (MAP) to help them take their medication. Participants in the alert arms were sent emails, text messages, or automated phone calls if they had failed to adhere on the previous day and on one or both of the 2 days before that. In partner?+?alert, both participants and fully enrolled MAPs received alerts. MAIN MEASURES:Adherence measured by wireless pill bottle opening. KEY RESULTS:Compared to 36.0% adherence in control, adherence was significantly greater in the alert arm (52.9%, difference vs. control of 17.0%, 95% CI for difference 6.3 to 27.6%, P?=?0.002) and the partner?+?alert arm (54.5%, difference vs. control of 18.6%, 95% CI for difference 6.6 to 30.5%, P?=?0.003). Adherence in the partner arm was not statistically significantly greater than control (43.2%, difference vs. control of 7.2%, 95% CI of difference -?5.2% to 19.5%, P?=?0.25). There were no statistically significant differences among the three treatment arms. Fewer participants invited a MAP in the partner?+?alert arm than the partner arm (P?=?0.02). CONCLUSIONS:Automated alerts were effective at improving medication adherence. Assigning a medication adherence partner did not statistically significantly affect adherence rates. TRIAL REGISTRATION:ClinicalTrials.gov Number NCT01890018 [ https://clinicaltrials.gov /].

Project description:INTRODUCTION:The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. METHODS AND ANALYSIS:Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. TRIAL REGISTRATION NUMBER:ACTRN12616000661471; Pre-results.

Project description:Importance:Although hand hygiene (HH) is considered the most effective strategy for preventing hospital-acquired infections, HH adherence rates remain poor. Objective:To examine whether the frequency of changing reminder signs affects HH adherence among health care workers. Design, Setting, and Participants:This cluster randomized clinical trial in 9 US Department of Veterans Affairs acute care hospitals randomly assigned 58 inpatient units to 1 of 3 schedules for changing signs designed to promote HH adherence among health care workers: (1) no change; (2) weekly; and (3) monthly. Hand hygiene rates among health care workers were documented at entry and exit to patient rooms during the baseline period from October 1, 2014, to March 31, 2015, of normal signage and throughout the intervention period of June 8, 2015, to December 28, 2015. Data analyses were conducted in April 2018. Interventions:Hospital units were randomly assigned into 3 groups: (1) no sign changes throughout the intervention period, (2) signs changed weekly, and (3) signs changed monthly. Main Outcomes and Measures:Hand hygiene adherence as measured by covert observation. Interrupted time series analysis was used to examine changes in HH adherence from baseline through the intervention period by group. Results:Among 58 inpatient units, 19 units were assigned to the no change group, 19 units were assigned to the weekly change group, and 20 units were assigned to the monthly change group. During the baseline period, 9755 HH opportunities were observed at room entry and 10?095 HH opportunities were observed at room exit. During the intervention period, a total of 15?855 HH opportunities were observed at room entry, and 16?360 HH opportunities were observed at room exit. Overall HH adherence did not change from baseline compared with the intervention period at either room entry (4770 HH events [48.9%] vs 3057 HH events [50.1%]; P?=?.14) or exit (6439 HH events [63.8%] vs 4087 HH events [65.2%]; P?=?.06). In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P?<?.001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P?=?.02). No significant changes in HH adherence were observed in other groups. Conclusions and Relevance:The frequency of changing reminder signs had no effect on HH rates overall. Units assigned to change signs most frequently demonstrated worsening adherence. Considering the abundance of signs in the acute care environment, the frequency of changing signs did not appear to provide a strong enough cue by itself to promote behavioral change. Trial Registration:ClinicalTrials.gov Identifier: NCT02223455.

Project description:ImportanceStereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions.ObjectiveTo examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race.Design, setting, and participantsThe Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis.InterventionsFrom a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values.Main outcomes and measuresThe primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured.ResultsOf 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]).Conclusions and relevanceA values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension.Trial registrationClinicalTrials.gov Identifier: NCT03028597.

Project description:BackgroundMedication nonadherence is a global public health challenge that results in suboptimal health outcomes and increases health care costs. Forgetting to take medicines is one of the most common reasons for unintentional medication nonadherence. Research findings indicate that voice-activated virtual home assistants, such as Amazon Echo and Google Home devices, may be useful in promoting medication adherence.ObjectiveThis study aims to create a medication adherence app (skill), MedBuddy, for Amazon Echo devices and measure the use, usability, and usefulness of this medication-taking reminder skill.MethodsA single-group, mixed methods, cohort feasibility study was conducted with women who took oral contraceptives (N=25). Participants were undergraduate students (age: mean 21.8 years, SD 6.2) at an urban university in the Southeast United States. Participants were given an Amazon Echo Dot with MedBuddy-a new medication reminder skill for Echo devices created by our team-attached to their study account, which they used for 60 days. Participants self-reported their baseline and poststudy medication adherence. MedBuddy use was objectively evaluated by tracking participants' interactions with MedBuddy through Amazon Alexa. The usability and usefulness of MedBuddy were evaluated through a poststudy interview in which participants responded to both quantitative and qualitative questions.ResultsParticipants' interactions with MedBuddy, as tracked through Amazon Alexa, only occurred on half of the study days (mean 50.97, SD 29.5). At study end, participants reported missing their medication less in the past 1 and 6 months compared with baseline (χ21=0.9 and χ21=0.4, respectively; McNemar test: P<.001 for both). However, there was no significant difference in participants' reported adherence to consistently taking medication within the same 2-hour time frame every day in the past 1 or 6 months at the end of the study compared with baseline (χ21=3.5 and χ21=0.4, respectively; McNemar test: P=.63 and P=.07, respectively). Overall feedback about usability was positive, and participants provided constructive feedback about the skill's features that could be improved. Participants' evaluation of MedBuddy's usefulness was overwhelmingly positive-most (15/23, 65%) said that they would continue using MedBuddy as a medication reminder if provided with the opportunity and that they would recommend it to others. MedBuddy features that participants enjoyed were an external prompt separate from their phone, the ability to hear the reminder prompt from a separate room, multiple reminders, and verbal responses to prompts.ConclusionsThe findings of this feasibility study indicate that the MedBuddy medication reminder skill may be useful in promoting medication adherence. However, the skill could benefit from further usability enhancements.

Project description:ImportanceIncentive spirometers (ISs) were developed to reduce atelectasis and are in widespread clinical use. However, without IS use adherence data, the effectiveness of IS cannot be determined.ObjectiveTo evaluate the effect of a use-tracking IS reminder on patient adherence and clinical outcomes following coronary artery bypass grafting (CABG) surgery.Design, setting, and participantsThis randomized clinical trial was conducted from June 5, 2017, to December 29, 2017, at a tertiary referral teaching hospital and included 212 patients who underwent CABG, of whom 160 participants were randomized (intent to treat), with 145 completing the study per protocol. Participants were stratified by surgical urgency (elective vs nonelective) and sex (men vs women).InterventionsA use-tracking, IS add-on device (SpiroTimer) with an integrated use reminder bell recorded and timestamped participants' inspiratory breaths. Patients were randomized by hourly reminder "bell on" (experimental group) or "bell off" (control group).Main outcomes and measuresIncentive spirometer use was recorded for the entire postoperative stay and compared between groups. Radiographic atelectasis severity (score, 0-10) was the primary clinical outcome. Secondary respiratory and nonrespiratory outcomes were also evaluated.ResultsA total of 145 per-protocol participants (112 men [77%]; mean age, 69 years [95% CI, 67-70]; 90 [62%] undergoing a nonelective procedure) were evaluated, with 74 (51.0%) in the bell off group and 71 (49.0%) in the bell on group. The baseline medical and motivation-to-recover characteristics of the 2 groups were similar. The mean number of daily inspiratory breaths was greater in bell on (35; 95% CI, 29-43 vs 17; 95% CI, 13-23; P < .001). The percentage of recorded hours with an inspiratory breath event was greater in bell on (58%; 95% CI, 51-65 vs 28%; 95% CI, 23-32; P < .001). Despite no differences in the first postoperative chest radiograph mean atelectasis severity scores (2.3; 95% CI, 2.0-2.6 vs 2.4; 95% CI, 2.2-2.7; P = .48), the mean atelectasis severity scores for the final chest radiographs conducted before discharge were significantly lower for bell on than bell off group (1.5; 95% CI, 1.3-1.8 vs 1.8; 95% CI, 1.6-2.1; P = .04). Of those with early postoperative fevers, fever duration was shorter for bell on (3.2 hours; 95% CI, 2.3-4.6 vs 5.2 hours; 95% CI, 3.9-7.0; P = .04). Having the bell turned on reduced noninvasive positive pressure ventilation use rates (37.2%; 95% CI, 24.1%-52.5% vs 19.2%; 95% CI, 10.2%-33.0%; P = .03) for participants undergoing nonelective procedures. Bell on reduced the median postoperative length of stay (7 days; 95% CI, 6-9 vs 6 days; 95% CI, 6-7; P = .048) and the intensive care unit length of stay for patients undergoing nonelective procedures (4 days; 95% CI, 3-5 vs 3 days; 95% CI, 3-4; P = .02). At 6 months, the bell off mortality rate was higher than bell on (9% vs 0%, P = .048) for participants undergoing nonelective procedures.Conclusions and relevanceThe incentive spirometer reminder improved patient adherence, atelectasis severity, early postoperative fever duration, noninvasive positive pressure ventilation use, ICU and length of stay, and 6-month mortality in certain patients. With the reminder, IS appears to be clinically effective when used appropriately.Trial registrationClinicalTrials.gov identifier: NCT02952027.

Project description:BackgroundPatient characteristics are associated with adherence, which has implications for planning clinical research or designing payment systems that reward superior outcomes. It is unclear to what extent clinician efforts to improve adherence can attenuate these associations.MethodsTo identify factors predicting visit and medication adherence in settings designed to optimize adherence, we did a retrospective analysis of participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT recruited participants at 632 sites in North America, Puerto Rico, and the U.S. Virgin Islands for random assignment to antihypertensive treatment with amlodipine, chlorthalidone, or lisinopril. Site investigators reported clinic characteristics at the time they applied to participate in the study and research coordinators used standardized methods to measure patient characteristics. We defined adequate visit adherence as attending at least 80 % of scheduled visits; adequate medication adherence was defined as taking 80 % or more of the randomly assigned medication at all study visits.ResultsThe 31,250 ALLHAT participants eligible for the visit adherence analysis attended 78.5 % of scheduled study visits; 68.9 % attended more than 80 % of scheduled visits. Clinic setting was predictive of both forms of adherence; adherence was worst at private clinics; clinics that enrolled more study participants had superior adherence. Adjusting for clinic characteristics and clinical factors, women, younger participants, Blacks and smokers were less likely to have adequate visit adherence. Among the 28,967 participants eligible for the medication adherence analysis, 21,261 (73.4 %) reported adequate medication adherence. In adjusted analyses, younger and less educated participants, Blacks, and smokers were less likely to report adequate adherence.ConclusionsParticipant demographics were associated with adherence despite strenuous efforts to optimize adherence. Our results could inform decisions by researchers planning trials and policymakers designing payment systems.Trial registrationNCT00000542 . Registered 27 October 1999.

Project description:ImportanceThe rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes.ObjectiveTo measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis.DesignWe conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day.SettingPublic and private sector tuberculosis clinics in Karachi, Pakistan.ParticipantsNewly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group.Main outcomeThe primary outcome was clinically recorded treatment success based upon intention-to-treat.ResultsWe found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment.ConclusionIn this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact.Trial registrationThe trial was registered with ClinicalTrials.gov, NCT01690754.