JMIR Publications

ABSTRACT

Background:

Population aging has major social and economic consequences. Although many older people can support themselves and continue to make important contributions to society, the burden of disease and disability increases with age. One condition that affects older people is dementia. Even in the early stages it can be burdensome for those affected as well as their relatives. Technology to support the day-to-day living activities at home for people with cognitive impairments have been developed during the last years. Most products focus on single problem solution and few are integrated into a single product. The impact of these devices is seldom studied in other ways than through feasibility studies. Randomized controlled studies (RCT) investigating the effect or effectiveness of these products are sparse.

Objective:

We aim to test the influence on Quality of Life (QoL) of persons with mild cognitive impairment (PwMCI) and carers who use a digital platform (SMART4MD). Also studied are influence on medication adherence, cognitive impairment, functional decline, service utilization and economic analysis.

Methods:

A pragmatic, multicenter RCT following the CONSORT guidelines is performed in Spain, Sweden and Belgium: Consorci Sanitari de Terrassa (Catalonia, Spain), Servicio Andaluz de Salud (Andalusia, Spain), Blekinge Institute of Technology (Sweden) and University Colleges Leuven-Limburg (Belgium). 1200 dyads is the target for recruitment: an intervention group and a control group whom are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD application (a general e-health application adapted specifically for mild cognitive impairment). Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities and sharing health information.

Results:

Inclusion of participants started in December 2017 and recruitment is expected to end in February 2019. Three follow-up visits at 6, 12 and 18 months after the baseline visit.

Conclusions:

The benefits of this RCT will be at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered ICT solution for this particular group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group’s relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people, rather than a source of anxiety. Since effect and effectiveness studies of e-health related products are demanded, results and experiences from this full scale RCT can hopefully serve as a model for further studies in this field. Clinical Trial: ClinicalTrials.gov Identifier: NCT03325699.