Health Technology Assessment (HTA) plays a pivotal role in decision-making within the healthcare sectors of developed countries, such as Sweden and Spain. This thesis investigates the efficacy and cost-effectiveness of a mobile health (mHealth) intervention in addition to standard care compared to standard care only. The intervention, a tablet-based application named Support, Monitoring and Reminder Technology for Mild Dementia (SMART4MD), was implemented in an 18-month pragmatic randomized controlled trial involving persons with mild cognitive impairment (PwMCI) and their informal caregivers. The trial was conducted in Sweden, Spain, and Belgium from December 2017 to September 2020. Its objective was to enhance or sustain the health-related quality of life (HRQoL) of PwMCI and their informal caregivers. Out of the total 1083 participants, 539 were assigned to the intervention group and 544 to the control group. The Belgium site was excluded from analyses due to its low participant count (n=5) and all participants were lost to follow-up at the 18-month. The aim of this thesis was to evaluate the effectiveness and cost-effectiveness of the mHealth intervention introduced through the SMART4MD trial. 

Four studies were undertaken to achieve this objective. Study I encompassed a systematic literature review, aiming to gather and critically appraise the existing evidence available on cost-effectiveness of mHealth intervention designed for older adults. Study I found limited evidence of mHealth interventions being cost-effective within this demographic. 

The effect outcomes data for the remaining three studies was obtained from the SMART4MD trial, while healthcare utilization data for Studies II and IV was retrieved from healthcare registers of the Blekinge regional council, Sweden and Hospital de Terrassa, Terrassa Sanitary Consortium, Terrassa (Barcelona), Spain. 

The effectiveness of the SMART4MD application in addition to standard care compared to standard care alone was investigated across Sweden and Spain during the 18-month trial period (Study III). For PwMCI, the primary outcome measure was quality of life in Alzheimer’s disease scale (QoL-AD), while secondary outcome measures included quality adjusted life years (QALY) measured by EQ-5D-3L index score, mini-mental state examination (MMSE) score, functional status by the Lawton instrumental activities of daily living (IADL) scale and medication adherence. The outcome measures for informal caregivers were QALY and caregiver burden. The findings were presented in terms of the mean changes in outcome measures between the intervention and control groups. For PwMCI, no statistically significant differences were observed between the intervention and control groups. In contrast, the results indicated a significant improvement in the health-related quality of life (measured by QALY) for informal caregivers and dyads in the intervention group when compared to the control group at 18-month follow-up. Notably, the dropout rate was 41.9% within the intervention group (225/537) and 37.7% within the control group (204/541), with a p-value of 0.160 showing insignificant difference in dropout between the groups. 

The within-trial cost-effectiveness of the mHealth intervention (tablet-based application) was investigated at short-term (6-month) and for the trial duration (18-month) from the perspective of the healthcare provider (Studies II and IV respectively). These analyses were based on the study sample collected from the Swedish site, due to the unavailability of cost data from the Spanish sites, except for PwMCI from CST site. The primary outcome measure was QALY for both PwMCI and informal caregivers, whereas the secondary outcome measures were QoL-AD, and MMSE for PwMCI, and Zarit burden interview short form (ZBI) for informal caregivers. Results were presented in terms of incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). Both short-term and full trial duration results indicated that intervention was dominated by standard care for PwMCI and dyads. Further, intervention was not found cost-effective for informal caregivers in terms of improving HRQoL.

The overall results of this thesis indicate that the app provided in the SMART4MD trial did not significantly improve the quality of life or prove to be cost-effective for PwMCI. However, it did improve the quality of life of informal caregivers, though it was not found to be cost-effective for them either. Further research in this area is needed, particularly through larger sample sizes, longer follow-up, and incentives for sustained app usage. Additionally, further investigations should prioritize strategies to minimize dropout rates within mHealth interventions.