A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

Abstract

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

Assessing the acceptability of a text messaging service and smartphone app to support patient adherence to medications prescribed for high blood pressure: a pilot study.

“…'How much of the time during the past month have you felt calm and peaceful'). The tailoring questionnaires was developed based on our previous studies [11,13]. Patients' answers to these questions were used to tailor the content of the advice messages.…”

“…Our recent meta-analyses suggested that automated telephone-based interventions, including text messages [7] and apps [10] double the odds for adherence to medication prescribed for long-term health conditions. Our recent feasibility trial found that digital interventions, including text messages, can provide highly tailored advice to address either or both NINA and INA for medication adherence, and is feasible and potentially effective adjunct to primary care consultations [11]. However, there is no intervention that has combined text messages with a smartphone app, to both maximize the reach of the intervention and to utilise the advantages of the automated tracking technology emended into apps when facilitating a highly tailored behaviour change intervention.…”

“…Based on our previous promising ndings [11] we have developed a 56-days prototype intervention, which we call PAM (Programme on Adherence to Medication), delivered by a text messaging service followed by a smartphone app. This pilot study aimed to pre-test its acceptability to support medication adherence in patients with hypertension.…”

Pharmacoadherence: An Opportunity for Digital Health to Inform the Third Dimension of Pharmacotherapy for Diabetes

“…• • access to the electronic health record, 35,36 • • nudge reminders that subtly encourage rather than mandate change, 37 • • mobile apps sending messages, 38 • • text messaging, 39,40 • • voice messaging by phone, 41 • • serious video games to educate or motivate about medications, 42 and • • multimodal interventions, eg, "Smartphone Medication Adherence Saves Kidneys" for kidney transplantation recipients, consisting of automated reminders and text messages along with automated summary reports for HCPs. 43 These seven forms of communication platforms are examples of telehealth communication rather than true DH, which uses sensor input to determine the type and intensity of the intervention.…”

Assessing the acceptability of a text messaging service and smartphone app to support patient adherence to medications prescribed for high blood pressure: a pilot study.

“…Participants were asked to respond to the query message one per week (when testing the text messages) or when each medication was taken (when switching to the smartphone app). The concept of the query message arose from the behaviour change strategy of 'reporting whether or not the behaviour was performed' [7,11,16]. All participants reported to query messages and most reported that they liked these messages (see Table 3 and Figure 2).…”