Prof Eric P Moll van Charante MD , Marieke P Hoevenaar-Blom PhD , Manshu Song PhD , Prof Sandrine Andrieu MD , Linda Barnes RGN , Cindy Birck PhD , Rachael Brooks BA , Nicola Coley PhD , Esmé Eggink PhD , Jean Georges PhD , Melanie Hafdi PhD , Prof Willem A van Gool MD , Ron Handels PhD , Haifeng Hou PhD , Prof Jihui Lyu MD , Prof Yixuan Niu MD , Libin Song BSc , Prof Wenzhi Wang PhD , Prof Youxin Wang PhD , Anders Wimo PhD , Xi Wei
{"title":"Prevention of dementia using mobile phone applications (PRODEMOS): a multinational, randomised, controlled effectiveness–implementation trial","authors":"Prof Eric P Moll van Charante MD , Marieke P Hoevenaar-Blom PhD , Manshu Song PhD , Prof Sandrine Andrieu MD , Linda Barnes RGN , Cindy Birck PhD , Rachael Brooks BA , Nicola Coley PhD , Esmé Eggink PhD , Jean Georges PhD , Melanie Hafdi PhD , Prof Willem A van Gool MD , Ron Handels PhD , Haifeng Hou PhD , Prof Jihui Lyu MD , Prof Yixuan Niu MD , Libin Song BSc , Prof Wenzhi Wang PhD , Prof Youxin Wang PhD , Anders Wimo PhD , Xi Wei","doi":"10.1016/S2666-7568(24)00068-0","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>The expected increase of dementia prevalence in the coming decades will mainly be in low-income and middle-income countries and in people with low socioeconomic status in high-income countries. This study aims to reduce dementia risk factors in underserved populations at high-risk using a coach-supported mobile health (mHealth) intervention.</p></div><div><h3>Methods</h3><p>This open-label, blinded endpoint, hybrid effectiveness–implementation randomised controlled trial (RCT) investigated whether a coach-supported mHealth intervention can reduce dementia risk in people aged 55–75 years of low socioeconomic status in the UK or from the general population in China with at least two dementia risk factors. The primary effectiveness outcome was change in cardiovascular risk factors, ageing, and incidence of dementia (CAIDE) risk score from baseline to after 12–18 months of intervention. Implementation outcomes were coverage, adoption, sustainability, appropriateness, acceptability, fidelity, feasibility, and costs assessed using a mixed-methods approach. All participants with complete data on the primary outcome, without imputation of missing outcomes were included in the analysis (intention-to-treat principle). This trial is registered with ISRCTN, ISRCTN15986016, and is completed.</p></div><div><h3>Findings</h3><p>Between Jan 15, 2021, and April 18, 2023, 1488 people (601 male and 887 female) were randomly assigned (734 to intervention and 754 to control), with 1229 (83%) of 1488 available for analysis of the primary effectiveness outcome. After a mean follow-up of 16 months (SD 2·5), the mean CAIDE score improved 0·16 points in the intervention group versus 0·01 in the control group (mean difference –0·16, 95% CI –0·29 to –0·03). 1533 (10%) invited individuals responded; of the intervention participants, 593 (81%) of 734 adopted the intervention and 367 (50%) of 734 continued active participation throughout the study. Perceived appropriateness (85%), acceptability (81%), and fidelity (79%) were good, with fair overall feasibility (53% of intervention participants and 58% of coaches), at low cost. No differences in adverse events between study arms were found.</p></div><div><h3>Interpretation</h3><p>A coach-supported mHealth intervention is modestly effective in reducing dementia risk factors in those with low socioeconomic status in the UK and any socioeconomic status in China. Implementation is challenging in these populations, but those reached actively participated. Whether this intervention will result in less cognitive decline and dementia requires a larger RCT with long follow-up.</p></div><div><h3>Funding</h3><p>EU Horizon 2020 Research and Innovation Programme and the National Key R&D Programmes of China.</p></div><div><h3>Translation</h3><p>For the Mandarin translation of the abstract see Supplementary Materials section.</p></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":"5 6","pages":"Pages e431-e442"},"PeriodicalIF":13.4000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756824000680/pdfft?md5=347ab4be77fe24ccc214ac7df12a2777&pid=1-s2.0-S2666756824000680-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Healthy Longevity","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666756824000680","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GERIATRICS & GERONTOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background
The expected increase of dementia prevalence in the coming decades will mainly be in low-income and middle-income countries and in people with low socioeconomic status in high-income countries. This study aims to reduce dementia risk factors in underserved populations at high-risk using a coach-supported mobile health (mHealth) intervention.
Methods
This open-label, blinded endpoint, hybrid effectiveness–implementation randomised controlled trial (RCT) investigated whether a coach-supported mHealth intervention can reduce dementia risk in people aged 55–75 years of low socioeconomic status in the UK or from the general population in China with at least two dementia risk factors. The primary effectiveness outcome was change in cardiovascular risk factors, ageing, and incidence of dementia (CAIDE) risk score from baseline to after 12–18 months of intervention. Implementation outcomes were coverage, adoption, sustainability, appropriateness, acceptability, fidelity, feasibility, and costs assessed using a mixed-methods approach. All participants with complete data on the primary outcome, without imputation of missing outcomes were included in the analysis (intention-to-treat principle). This trial is registered with ISRCTN, ISRCTN15986016, and is completed.
Findings
Between Jan 15, 2021, and April 18, 2023, 1488 people (601 male and 887 female) were randomly assigned (734 to intervention and 754 to control), with 1229 (83%) of 1488 available for analysis of the primary effectiveness outcome. After a mean follow-up of 16 months (SD 2·5), the mean CAIDE score improved 0·16 points in the intervention group versus 0·01 in the control group (mean difference –0·16, 95% CI –0·29 to –0·03). 1533 (10%) invited individuals responded; of the intervention participants, 593 (81%) of 734 adopted the intervention and 367 (50%) of 734 continued active participation throughout the study. Perceived appropriateness (85%), acceptability (81%), and fidelity (79%) were good, with fair overall feasibility (53% of intervention participants and 58% of coaches), at low cost. No differences in adverse events between study arms were found.
Interpretation
A coach-supported mHealth intervention is modestly effective in reducing dementia risk factors in those with low socioeconomic status in the UK and any socioeconomic status in China. Implementation is challenging in these populations, but those reached actively participated. Whether this intervention will result in less cognitive decline and dementia requires a larger RCT with long follow-up.
Funding
EU Horizon 2020 Research and Innovation Programme and the National Key R&D Programmes of China.
Translation
For the Mandarin translation of the abstract see Supplementary Materials section.
期刊介绍：
The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.
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