JMIR Publications

ABSTRACT

Background:

Mild cognitive impairment (MCI) is a prevalent condition among older adults, often progressing to dementia and imposing significant burdens on healthcare systems and informal caregivers. Digital health interventions, such as the Support, Monitoring and Reminder Technology for Mild Dementia (SMART4MD) tablet application, have been proposed to support people living with MCI (PwMCI) and their caregivers by facilitating daily routines and improving quality of life (QoL). However, evidence regarding their long-term cost-effectiveness remains limited.

Objective:

This study aimed to evaluate the 18-month cost-effectiveness of the SMART4MD tablet-based intervention, in addition to standard care, compared to standard care alone for PwMCI and their informal caregivers, from the perspective of healthcare providers in Sweden and Spain.

Methods:

A pragmatic, multicenter randomized controlled trial was conducted between December 2017 and September 2020 across sites in Sweden and Spain. Dyads consisting of PwMCI and their informal caregivers were randomized to receive either the SMART4MD intervention plus standard care or standard care alone. The primary outcome was health-related quality of life, measured by quality-adjusted life years (QALYs) derived from the EQ-5D-3L instrument. Secondary outcomes included disease-specific QoL (QoL-AD), cognitive function (MMSE), and caregiver burden (Zarit Burden Interview, ZBI). Cost data were collected from healthcare provider registries, and economic evaluation followed the CHEERS guidelines. Incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated, with sensitivity and subgroup analyses performed to assess the uncertainties.

Results:

A total of 345 dyads were included in the Swedish cost-effectiveness analysis. After 18 months, there were no statistically significant differences in total costs or QALYs between the intervention and control groups for PwMCI, informal caregivers, or dyads. For PwMCI, the intervention was associated with slightly higher costs (€9) and lower QALYs (–0.015) compared to standard care, resulting in the intervention being dominated by standard care (negative NMB). For informal caregivers, the intervention group showed a small, non-significant QALY gain (0.006) at higher cost (€468), with an ICER above the Swedish willingness-to-pay threshold, indicating the intervention was not cost-effective. Scenario analysis in the Spanish site showed the intervention could be cost-effective for PwMCI (ICER €3,337/QALY), but differences were not statistically significant. Notably, the intervention group showed a statistically significant improvement in MMSE scores, but no significant differences in other outcomes.

Conclusions:

Over 18 months, the SMART4MD intervention did not result in significant improvements in quality of life for PwMCI or their informal caregivers compared to standard care. The intervention was not cost-effective from a healthcare provider perspective, except in a scenario analysis for one Spanish site. Further research with larger sample sizes, longer follow-up, and strategies to enhance engagement and minimize dropout is warranted to clarify the potential of digital interventions in this population. Clinical Trial: ClinicalTrials.gov: NCT03325699