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Health Technology Assessment of an mHealth application (SMART4MD) designed for persons with mild cognitive impairment (PwMCI) and their informal caregivers: Effectiveness and cost-effectiveness analyses
Blekinge Institute of Technology, Faculty of Engineering, Department of Health.ORCID iD: 0000-0001-9360-2809
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

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.

Place, publisher, year, edition, pages
Karlskrona: Blekinge Tekniska Högskola, 2024. , p. 109
Series
Blekinge Institute of Technology Doctoral Dissertation Series, ISSN 1653-2090 ; 2024:15
Keywords [en]
Aged, Cost-effectiveness analysis, Economic evaluation, Gerontechnology, Carer, Elderly, Memory, mHealth, Mild cognitive impairment, Mild dementia, Mobile application, Smartphone
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Research subject
Applied Health Technology
Identifiers
URN: urn:nbn:se:bth-26984ISBN: 978-91-7295-488-5 (print)OAI: oai:DiVA.org:bth-26984DiVA, id: diva2:1904301
Public defence
2024-11-20, J1630, Blekinge institute of technology, Karlskrona, 13:00 (English)
Opponent
Supervisors
Funder
EU, Horizon 2020, 643399Available from: 2024-10-14 Created: 2024-10-08 Last updated: 2025-09-30Bibliographically approved
List of papers
1. The cost-effectiveness of mobile health (Mhealth) interventions for older adults: Systematic review
Open this publication in new window or tab >>The cost-effectiveness of mobile health (Mhealth) interventions for older adults: Systematic review
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2020 (English)In: International Journal of Environmental Research and Public Health, ISSN 1661-7827, E-ISSN 1660-4601, Vol. 17, no 15, p. 1-13, article id 5290Article, review/survey (Refereed) Published
Abstract [en]

The objective of this study was to critically assess and review empirical evidence on the cost-effectiveness of Mobile Health (mHealth) interventions for older adults. We systematically searched databases such as Pubmed, Scopus, and Cumulative Index to Nursing and Allied Literature (CINAHL) for peer-reviewed economic evaluations published in English from 2007 to 2018. We extracted data on methods and empirical evidence (costs, effects, incremental cost-effectiveness ratio) and assessed if this evidence supported the reported findings in terms of cost-effectiveness. The consolidated health economic evaluation reporting standards (CHEERS) checklist was used to assess the reporting quality of the included studies. Eleven studies were identified and categorized into two groups: complex smartphone communication and simple text-based communication. Substantial heterogeneity among the studies in terms of methodological approaches and types of intervention was observed. The cost-effectiveness of complex smartphone communication interventions cannot be judged due to lack of information. Limited evidence of cost-effectiveness was found for interventions related to simple text-based communications. Comprehensive economic evaluation studies are warranted to assess the cost-effectiveness of mHealth interventions designed for older adults. © 2020 by the authors. Licensee MDPI, Basel, Switzerland.

Place, publisher, year, edition, pages
MDPI AG, 2020
Keywords
Aged, Cost-benefit analysis, Economic evaluation, Gerontechnology, Telemedicine, database, elderly care, elderly population, health care, information system, literature review, mobile communication, mobile phone, technology adoption, chronic obstructive lung disease, cost benefit analysis, cost effectiveness analysis, cost minimization analysis, cost utility analysis, diabetes mellitus, follow up, heart disease, human, intervention study, malignant neoplasm, Parkinson disease, peer review, practice guideline, quality adjusted life year, Review, systematic review, text messaging, Unified Parkinson Disease Rating Scale, Willingness To Pay, Scopus
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:bth-20285 (URN)10.3390/ijerph17155290 (DOI)000567271000001 ()2-s2.0-85088283747 (Scopus ID)
Funder
EU, Horizon 2020, 643399
Note

Open access

Available from: 2020-08-14 Created: 2020-08-14 Last updated: 2025-09-30Bibliographically approved
2. Short Term Economic Evaluation of the Digital Platform "Support, Monitoring and Reminder Technology for Mild Dementia" (SMART4MD) for People with Mild Cognitive Impairment and their Informal Caregivers
Open this publication in new window or tab >>Short Term Economic Evaluation of the Digital Platform "Support, Monitoring and Reminder Technology for Mild Dementia" (SMART4MD) for People with Mild Cognitive Impairment and their Informal Caregivers
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2022 (English)In: Journal of Alzheimer's Disease, ISSN 1387-2877, E-ISSN 1875-8908, Vol. 86, no 4, p. 1629-1641Article in journal (Refereed) Published
Abstract [en]

Background: A randomized controlled trial of the SMART4MD tablet application was conducted for persons with mild cognitive impairment (PwMCI) and their informal caregivers to improve or maintain quality of life. Objective: The objective was to conduct economic evaluation of SMART4MD compared to standard care in Sweden from a healthcare provider perspective based on a 6-month follow-up period. Methods: Three hundred forty-five dyads were enrolled: 173 dyads in the intervention group and 172 in standard care. The primary outcome measures for PwMCI and informal caregivers were quality-adjusted life years (QALY). The results are presented as incremental cost-effectiveness ratios, and confidence intervals are calculated using non-parametric bootstrap procedure. Results: For PwMCI, the mean difference in total costs between intervention and standard care was (sic)12 (95%CI: -2090 to 2115) (US$ =(sic) 1.19) and the mean QALY change was -0.004 (95%CI: -0.009 to 0.002). For informal caregivers, the cost difference was -(sic)539 (95%CI: -2624 to 1545) and 0.003 (95%CI: -0.002 to 0.008) for QALY. The difference in cost and QALY for PwMCI and informal caregivers combined was -(sic)527 (95%CI: -3621 to 2568) and -0.001 (95%CI: -0.008 to 0.006). Although generally insignificant differences, this indicates that SMART4MD, compared to standard care was: 1) more costly and less effective for PwMCI, 2) less costly and more effective for informal caregivers, and 3) less costly and less effective for PwMCI and informal caregivers combined. Conclusion: The cost-effectiveness of SMART4MD over 6 months is inconclusive, although the intervention might be more beneficial for informal caregivers than PwMCI.

Place, publisher, year, edition, pages
IOS Press, 2022
Keywords
Carer, cost-effectiveness, economic evaluation, elderly, memory, mHealth, mild cognitive impairment, mild dementia, mobile application, smartphone, COST-EFFECTIVENESS ANALYSIS, MINI-MENTAL-STATE, QUALITY-OF-LIFE, ALZHEIMERS-DISEASE, CLINICAL-TRIALS, EQ-5D, BURDEN
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:bth-22892 (URN)10.3233/JAD-215013 (DOI)000784452600010 ()35213366 (PubMedID)2-s2.0-85129312070 (Scopus ID)
Projects
SMART4MD
Funder
EU, Horizon 2020, 643399
Note

open access

Available from: 2022-05-06 Created: 2022-05-06 Last updated: 2025-09-30Bibliographically approved
3. Erratum to: Short Term Economic Evaluation of the Digital Platform “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for People with Mild Cognitive Impairment and Their Informal Caregivers
Open this publication in new window or tab >>Erratum to: Short Term Economic Evaluation of the Digital Platform “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for People with Mild Cognitive Impairment and Their Informal Caregivers
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2024 (English)In: Journal of Alzheimer's Disease, ISSN 1387-2877, E-ISSN 1875-8908, Vol. 99, no 2, p. 799-810Article in journal (Other academic) Published
Abstract [en]

This contribution corrects cost data from our previously published version in which the 6-month cost data was not censored at baseline and 6-month survey dates. Consequently, the average costs for persons with mild cognitive impairment (PwMCI) and their informal caregivers include costs that occurred outside the initial 6-month period for both intervention and control groups. In this erratum, we have repeated the analysis after appropriately censoring the costs. The results led to numerical differences. However, as both the intervention and control groups have been treated exactly the same, the differences between groups remain insignificant and the general interpretation of the results stand as presented in the original publication. The interpretation of the results in terms of cost-effectiveness has changed for informal caregivers, shifting from "dominant" to "not cost-effective", and for dyads, shifting from "less costly and less effective" to "more costly and less effective". Consequently, ICER and CEAC curves have also changed (see Corrected Fig. 1). However, these changes did not affect the conclusion of the article. 

Keywords
aged, Alzheimer disease, caregiver, clinical article, controlled study, cost effectiveness analysis, dementia, disease management, drug therapy, economic evaluation, informal caregiver, memory, mild cognitive impairment, mobile application, smartphone, telehealth, therapy, erratum
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Research subject
Applied Health Technology
Identifiers
urn:nbn:se:bth-26986 (URN)10.3233/jad-249009 (DOI)38701171 (PubMedID)2-s2.0-85193646507 (Scopus ID)
Available from: 2024-10-08 Created: 2024-10-08 Last updated: 2025-09-30Bibliographically approved
4. Effectiveness of the digital application “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for people with mild cognitive impairment and their informal caregivers
Open this publication in new window or tab >>Effectiveness of the digital application “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for people with mild cognitive impairment and their informal caregivers
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(English)Manuscript (preprint) (Other academic)
Abstract [en]

Background

We evaluated the effectiveness of the SMART4MD tablet app in improving the quality of lives of persons with mild cognitive impairment (PwMCI) and their caregivers, through medication reminders and health appointment alerts. 

Methods and Findings

An 18-month pragmatic randomized controlled trial was conducted in Spain and Sweden from December 2017 to September 2020 and included 1078 PwMCIs and their informal caregivers. 

For PwMCI, there was no significant effect in quality of life or medication adherence. However, quality of life measured by QALY was significantly improved for both caregivers and dyads in the intervention group. A dropout rate of around 40% was noted in both intervention and control groups.

Conclusions

The overall results suggest that the SMART4MD app does not add additional benefits beyond standard care over the 18-month study period except for informal caregivers. 

National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Research subject
Applied Health Technology
Identifiers
urn:nbn:se:bth-26987 (URN)
Funder
EU, Horizon 2020, 643399
Available from: 2024-10-08 Created: 2024-10-08 Last updated: 2025-09-30Bibliographically approved
5. Economic evaluation of the digital application “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for people with mild cognitive impairment and their informal caregivers
Open this publication in new window or tab >>Economic evaluation of the digital application “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for people with mild cognitive impairment and their informal caregivers
Show others...
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Background

The study evaluated the cost-effectiveness of a customised, tablet-based application (SMART4MD) which is developed to support people living with mild cognitive impairment and their informal caregivers.  

Methods

In a pragmatic randomized controlled trial, people with mild cognitive impairment (PwMCI) and their informal caregivers were randomised to intervention and control groups. Intervention group was asked to use SMART4MD app for 18 months.  Control group received standard care. Healthcare costs, quality-adjusted life years (QALY), incremental cost-effectiveness ratios were measured (ICER) in 345 Swedish PwMCI and their informal caregivers and 347 Spanish PwMCI.

Results

The analysis showed higher incremental costs and lower QALYs for Swedish PwMCI than controls whereas higher incremental costs and higher QALYs were observed for Spanish PwMCI. The intervention was found to be not cost-effective for the Swedish informal caregivers with an ICER of €78,000/QALY. In contrast, the Spanish site found the intervention cost-effective for PwMCI yielding an ICER of €3,337/QALY.

Discussion

The divergent findings regarding cost-effectiveness for PwMCI in Sweden and Spain necessitate further research with extended follow-up, ideally involving an increased sample size and conducted in different national contexts.

National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Research subject
Applied Health Technology
Identifiers
urn:nbn:se:bth-26988 (URN)
Funder
EU, Horizon 2020, 643399
Available from: 2024-10-08 Created: 2024-10-08 Last updated: 2025-09-30Bibliographically approved

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