ISRCTN15986016已完成未知
Prevention of dementia using mobile phone applications: a randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- AMC
- 入组人数
- 2,400
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34108173/ (added 13/08/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36414280/ qualitative pre-results (added 28/11/2022) 2024 Results article in https://doi.org/10.1016/s2666-7568(24)00068-0 (added 20/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age = 55 years - 75 years
- •2. Good proficiency of the national language (English in UK, Mandarin in China)
- •3. Possession of a smartphone
- •4. Persons who currently don’t have good access to preventive health care, including Low SES in the UK (Sussex and Greater Cambridge areas), operationalised as living in a postal code area ranked as equal to or less than the 3rd decile of the index of multiple deprivation (IMD) OR inhabitant of the Greater Beijing area irrespective of SES.
- •5. = two dementia risk factors defined as:
- •5.1. Manifest cardiovascular disease, as diagnosed by specialist or general practitioner
- •5.2. Lack of physical exercise (self-reported), defined as below the World Health Organization (WHO) norm (five times a week 30 minutes or a total of 150 minutes per week of intermediate exercise)
- •5.3. Active smoking (self-reported use of any sort of tobacco in any quantity)
- •5.4. Hypertension, defined by any of the following:
- •5.4.1. Diagnosis by specialist or general practitioner.
- •5.4.2. Currently on anti-hypertensive drugs.
- •5.4.3. Baseline blood pressure: = 140/90 mmHg;
- •5.5. Overweight, defined by any of the following:
- •5.5.1. Body mass index (BMI) = 30 (UK) or 28 (China)
- •5.5.2. Waist circumference men = 102 cm (UK) or 90 cm (China), women = 88 cm or 85 cm (China)
- •5.6. Diabetes mellitus, defined by any of the following:
- •5.6.1. Diagnosis by specialist or general practitioner
- •5.6.2. Use of insulin or other blood glucose-lowering medication
- •5.7. Depression
- •5.7.1. Currently on anti-depressive medication or receiving psychotherapy
- •5.7.2. History of treatment (i.e. drug therapy, psychotherapy etc.) for depression
- •5.8. Dyslipidaemia, defined by any of the following:
- •5.8.1. Diagnosis by specialist or general practitioner
- •5.8.2. Use of lipid-lowering drugs
- •5.8.3. Baseline low density lipoprotein (LDL-C) = 3.0 mmol/L and/or total cholesterol = 5.0 mmol/L.
排除标准
- •1. Previously diagnosed with dementia by a specialist or general practitioner
- •2. Mini Mental State Examination (MMSE) < 24
- •3. Any condition expected to limit 18-months compliance and follow-up, including metastasised malignancy or other terminal illness
- •4. Smartphone illiteracy, defined as not able to send a message from a smartphone
- •5. Visual impairment interfering with operation of a smartphone
- •6. Participating in another RCT
- •7. Present alcohol or illicit drug abuse; binge drinking is not an exclusion criterion – this is a potential target for behaviour change
研究者
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