Prevention of dementia using mobile phone applications (PRODEMOS): a multinational, randomised, controlled effectiveness-implementation trial.

Journal

The lancet. Healthy longevity
ISSN: 2666-7568
Titre abrégé: Lancet Healthy Longev
Pays: England
ID NLM: 101773309

Informations de publication

Date de publication:
14 May 2024
Historique:
received: 21 12 2023
revised: 11 04 2024
accepted: 15 04 2024
medline: 20 5 2024
pubmed: 20 5 2024
entrez: 19 5 2024
Statut: aheadofprint

Résumé

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. 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. 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. 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. EU Horizon 2020 Research and Innovation Programme and the National Key R&D Programmes of China. For the Mandarin translation of the abstract see Supplementary Materials section.

Sections du résumé

BACKGROUND 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 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 RESULTS
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 CONCLUSIONS
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 BACKGROUND
EU Horizon 2020 Research and Innovation Programme and the National Key R&D Programmes of China.
TRANSLATION UNASSIGNED
For the Mandarin translation of the abstract see Supplementary Materials section.

Identifiants

DOI: 10.1016/S2666-7568(24)00068-0 PMID: 38763155
pubmed: 38763155
pii: S2666-7568(24)00068-0
doi: 10.1016/S2666-7568(24)00068-0
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Investigateurs

Patrick Witvliet (P)
Mart Hoitink (M)
Bram van de Groep (B)
Hongmei Liu (H)
Siqi Ge (S)
Mingyue He (M)
Cancan Li (C)
Xuening Jian (X)
Bin Jiang (B)
Haixin Sun (H)
Xiaojuan Ru (X)
Dongling Sun (D)
Tenghong Lian (T)
Weijiao Zhang (W)
Wenjing Zhang (W)
Jing Qi (J)
Jinghui Li (J)
Huiying Guan (H)
Dongmei Luo (D)
Weijia Zhang (W)
Hao Yue (H)
Zijing Zheng (Z)
Qiang Zeng (Q)
Huangdai Yang (H)
Yanyan Tang (Y)
Tianqi Tao (T)
Yan Song (Y)
Xiaosheng Meng (X)
Sirui Zhu (S)
Dongmei Jia (D)
Mo Li (M)
Wenjie Li (W)
Haiyan Mu (H)
Wenjing Jiang (W)
Wenchao Gao (W)
Yueqing Hu (Y)
Guohua Wang (G)
Xizhu Xu (X)
Yichun Zhang (Y)
Dong Li (D)
Xiaoyu Zhang (X)
Xiuhua Guo (X)
Xiaoyan Ye (X)
Xi Wei (X)

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests AW received research grants from EU IMI2 (MOPEAD), JPND (ADDITION, EURO-FINGER, PMI-AD), IHI (PROMINENT), and the Swedish VINNOVA program (PREDEM)(all paid to institution) and is licence holder of RUD-instrument (in part); outside the submitted work. RH received research grants from JPND, ZonMW, IMI, H2020 (paid to institution); received consulting fees from Lilly Nederland, iMTA, Biogen Nederlands, Biogen MA, Eisai (paid to institution); is a member of ISPOR special interest group open-source models, IPECAD modelling group and Alzheimer Europe Expert Advisory Panel (unpaid); outside the submitted work. SA received grants from EU (Institutional grant [Horizon 2020 Research and Innovation Programme agreement 779238]); Region Occitanie/Pyrénées-Méditerranée (1901175); the European Regional Development Fund (MP0022856); MSD Avenir Inspire Chairs of Excellence (Alzheimer Prevention in Occitania and Catalonia, EDENIS, KORIAN, Pfizer, and Pierre-Fabre); AXA Personal (current); Biogen Personal (2022); Roche Personal (2021); Leventis foundation (2022); ADI (2022); and has a leadership role in the French Alzheimer association (Scientific Committee); outside the submitted work. All other authors declare no competing interests.

Auteurs

Eric P Moll van Charante (EPM)

Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Department of Public and Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: e.p.mollvancharante@amsterdamumc.nl.

Marieke P Hoevenaar-Blom (MP)

Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Department of Public and Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.

Manshu Song (M)

Beijing Key Laboratory of Clinical Epidemiology, School of Public Health, Capital Medical University, Beijing, China; School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia.

Sandrine Andrieu (S)

Aging Research Team, Centre for Epidemiology and Research in Population Health, INSERM-University of Toulouse UPS, Toulouse, France; Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France.

Linda Barnes (L)

Department of Psychiatry, University of Cambridge, Cambridge, UK.

Cindy Birck (C)

Alzheimer Europe, Luxembourg, Luxembourg.

Rachael Brooks (R)

Department of Psychiatry, University of Cambridge, Cambridge, UK.

Nicola Coley (N)

Aging Research Team, Centre for Epidemiology and Research in Population Health, INSERM-University of Toulouse UPS, Toulouse, France; Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France.

Esmé Eggink (E)

Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.

Jean Georges (J)

Alzheimer Europe, Luxembourg, Luxembourg.

Melanie Hafdi (M)

Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.

Willem A van Gool (WA)

Department of Public and Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.

Ron Handels (R)

Division of Neurogeriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Solna, Sweden; Faculty of Health, Medicine, and Life Sciences Department of Psychiatry and Neuropsychology, Alzheimer Centre Limburg, School for Mental Health and Neuroscience, Maastricht University, Maastricht, Netherlands.

Haifeng Hou (H)

Centre for Precision Health, Edith Cowan University, Perth, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia; School of Public Health, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, Shandong, China.

Jihui Lyu (J)

Centre for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.

Yixuan Niu (Y)

Department of Geriatrics, The Second Medical Centre & National Clinical Research Centre for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China.

Libin Song (L)

Comvee Research Institute, Fuzhou Comvee Network & Technology, Fuzhou, China.

Wenzhi Wang (W)

Department of Neuroepidemiology, Beijing Neurosurgical Institute, Beijing, China.

Youxin Wang (Y)

Beijing Key Laboratory of Clinical Epidemiology, School of Public Health, Capital Medical University, Beijing, China; Centre for Precision Health, Edith Cowan University, Perth, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia.

Anders Wimo (A)

Division of Neurogeriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Solna, Sweden.

Yueyi Yu (Y)

Innovation Centre for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.

Jinxia Zhang (J)

Beijing Key Laboratory of Clinical Epidemiology, School of Public Health, Capital Medical University, Beijing, China; Centre for Precision Health, Edith Cowan University, Perth, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia.

Wei Zhang (W)

Centre for Cognitive Neurology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Carol Brayne (C)

Department of Psychiatry, University of Cambridge, Cambridge, UK.

Wei Wang (W)

Beijing Key Laboratory of Clinical Epidemiology, School of Public Health, Capital Medical University, Beijing, China; Centre for Precision Health, Edith Cowan University, Perth, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia; School of Public Health, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, Shandong, China; Department of Neuroepidemiology, Beijing Neurosurgical Institute, Beijing, China; The First Affiliated Hospital of Shantou University Medical College, Shantou, China.

Edo Richard (E)

Department of Public and Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.

Classifications MeSH