Review question
We reviewed the evidence on the effect of interventions delivered by mobile phone to help people in taking their medication to prevent cardiovascular disease (for example, heart attacks and strokes).
Background
Around 17.6 million people die from cardiovascular disease every year. Medications can help to prevent cardiovascular disease, but many people who have been given these medications do not take them as often or as consistently as recommended. This means that the medication will not work as well as it could to prevent cardiovascular disease. Interventions delivered through mobile phones, for example, prompting by text messaging, may be a low-cost way to help people to take their medication as recommended.
Study characteristics
The evidence is up to date to January 2020. We found 14 studies that tested interventions delivered at least partly by mobile phone, which followed up participants for at least 12 months.
Key results
We were not able to combine the results of most of the trials, because the interventions were very different. Two studies were at low risk of bias and 12 were at high risk of bias. The effects of the interventions were inconsistent across studies, and so we are not confident about their findings. Self-monitoring of blood pressure plus telemedicine support by mobile phone may improve blood pressure control, but we are not confident about the findings due to trials being at risk of bias. Interventions delivered by text message alone may have little or no effect on blood pressure control. Interventions which included text messages and clinician training or clinician decision support (with or without additional features) may have little or no effect on blood pressure or cholesterol. The effects of the interventions which included text messages and provider support (with or without other features) were inconsistent across studies, and so we are not confident about their findings. We are uncertain about the effects of apps held by the patient or apps with additional provider support. Some interventions delivered by mobile phone may help people to take their medication, but the benefits are small or modest. Some trials found that the interventions did not have any beneficial effect. There was no evidence to suggest that these types of interventions caused harm.
There is low-certainty evidence on the effects of mobile phone-delivered interventions to increase adherence to medication prescribed for the primary prevention of CVD. Trials of BP self-monitoring with mobile-phone telemedicine support reported modest benefits. One trial at low risk of bias reported modest reductions in LDL cholesterol but no benefits for BP. There is moderate-certainty evidence that these interventions do not result in harm. Further trials of these interventions are warranted.
Cardiovascular disease (CVD) is a major cause of disability and mortality globally. Premature fatal and non-fatal CVD is considered to be largely preventable through the control of risk factors by lifestyle modifications and preventive medication. Lipid-lowering and antihypertensive drug therapies for primary prevention are cost-effective in reducing CVD morbidity and mortality among high-risk people and are recommended by international guidelines. However, adherence to medication prescribed for the prevention of CVD can be poor. Approximately 9% of CVD cases in the EU are attributed to poor adherence to vascular medications. Low-cost, scalable interventions to improve adherence to medications for the primary prevention of CVD have potential to reduce morbidity, mortality and healthcare costs associated with CVD.
To establish the effectiveness of interventions delivered by mobile phone to improve adherence to medication prescribed for the primary prevention of CVD in adults.
We searched CENTRAL, MEDLINE, Embase, and two other databases on 7 January 2020. We also searched two clinical trials registers on 5 February 2020. We searched reference lists of relevant papers. We applied no language or date restrictions.
We included randomised controlled trials investigating interventions delivered wholly or partly by mobile phones to improve adherence to cardiovascular medications prescribed for the primary prevention of CVD. We only included trials with a minimum of one-year follow-up in order that the outcome measures related to longer-term, sustained medication adherence behaviours and outcomes. Eligible comparators were usual care or control groups receiving no mobile phone-delivered component of the intervention.
We used standard methodological procedures recommended by Cochrane. The main outcomes of interest were objective measures of medication adherence (blood pressure (BP) and cholesterol), CVD events, and adverse events. We contacted study authors for further information when this was not reported.
We included 14 trials with 25,633 randomised participants. Participants were recruited from community-based primary and tertiary care or outpatient clinics. The interventions varied widely from those delivered solely through short messaging service (SMS) to those involving a combination of modes of delivery, such as SMS in addition to healthcare worker training, face-to-face counselling, electronic pillboxes, written materials, and home blood pressure monitors. Some interventions only targeted medication adherence, while others additionally targeted lifestyle changes such as diet and exercise. Due to heterogeneity in the nature and delivery of the interventions and study populations, we reported most results narratively, with the exception of two trials which were similar enough to meaningfully pool in meta-analyses.
The body of evidence for the effect of mobile phone-based interventions on objective outcomes of adherence (BP and cholesterol) was of low certainty, due to most trials being at high risk of bias, and inconsistency in outcome effects. Two trials were at low risk of bias.
Among five trials (total study enrolment: 5441 participants) recording low-density lipoprotein cholesterol (LDL-C), two studies found evidence for a small beneficial intervention effect on reducing LDL-C (−5.30 mg/dL, 95% confidence interval (CI) −8.30 to −2.30; and −9.20 mg/dL, 95% CI −17.70 to −0.70). The other three studies found results varying from a small reduction (−7.7 mg/dL) to a small increase in LDL-C (0.77 mg/dL). All of which had wide confidence intervals that included no effect.
Across 13 studies (25,166 participants) measuring systolic blood pressure, effect estimates ranged from a large reduction (MD −12.45 mmHg, 95% CI −15.02 to −9.88) to a small increase (MD 2.80 mmHg, 95% CI 0.30 to 5.30). We found a similar range of effect estimates for diastolic BP, ranging from −12.23 mmHg (95% CI −14.03 to −10.43) to 1.64 mmHg (95% CI −0.55 to 3.83) (11 trials, 19,716 participants). Four trials showed intervention benefits for systolic and diastolic BP with confidence intervals excluding no effect, and among these were all three of the trials evaluating self-monitoring of blood pressure with mobile phone-based telemedicine. The fourth trial included SMS and provider support (with additional varied features). Seven studies (19,185 participants) reported 'controlled' BP as an outcome, and intervention effect estimates varied from negligible effects (odds ratio (OR) 1.01, 95% CI 0.76 to 1.34) to large improvements in BP control (OR 2.41, 95% CI: 1.57 to 3.68). The three trials of clinician training or decision support combined with SMS (with additional varied features) had confidence intervals encompassing benefits and harms, with point estimates close to zero. Pooled analyses of the two trials of interventions solely delivered through SMS were indicative of little or no beneficial intervention effect on systolic BP (MD −1.55 mmHg, 95% CI −3.36 to 0.25; I2 = 0%) and small increases in controlled BP (OR 1.32, 95% CI 1.06 to 1.65; I2 = 0%).
Based on four studies (12,439 participants), there was very low-certainty evidence (downgraded twice for imprecision and once for risk of bias) relating to the intervention effect on combined (fatal and non-fatal) CVD events.
Two studies (2535 participants) provided low-certainty evidence for the effect of the intervention on cognitive outcomes, with little or no difference between trial arms for perceived quality of care and satisfaction with treatment.
There was moderate-certainty evidence (downgraded due to risk of bias) that the interventions did not cause harm, based on six studies (8285 participants). Three studies reported no adverse events attributable to the intervention. One study reported no difference between groups in experience of adverse effects of statins, and that no participants reported intervention-related adverse events. One study stated that potential side effects were similar between groups. One study reported a similar number of deaths in each arm, but did not provide further information relating to potential adverse events.