ISRCTN92928122进行中（未招募）Unknown
mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO): a hybrid effectiveness-implementation randomized controlled trial in middle-aged persons with low SES and/or migration background
Amsterdam University Medical Centers0 个研究点目标入组 692 人开始时间: 2024年3月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 692
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/06/2024:
- •1. Age =50 years =75 years
- •2. Basic level of literacy in Dutch
- •3. Possession of a smartphone
- •4. Turkish or South-Asian Surinamese background; OR Dutch background with low SES, operationalised using educational level and occupational status
- •5. Increased risk of dementia based on = one dementia risk factor defined as:
- •5.1. Hypertension, defined by any of the following:
- •5.1.1. Diagnosis by specialist or general practitioner.
- •5.1.2. Currently on anti-hypertensive drugs.
- •5.1.3. Baseline blood pressure: =140/90 mmHg;
- •5.2. Dyslipidaemia, defined by any of the following:
- •5.2.1. Diagnosis by specialist or general practitioner
- •5.2.2. Use of lipid-lowering drugs
- •5.2.3. Baseline total cholesterol =5.0 mmol/L
- •5.3. Diabetes mellitus, defined by any of the following:
- •5.3.1. Diagnosis by specialist or general practitioner
- •5.3.2. Use of any blood glucose-lowering medication
- •5.4. Active smoking (use of any sort of tobacco in any quantity)
- •5.5. Overweight, defined by any of the following:
- •5.5.1. Body mass index (BMI) =30 kg/m²
- •5.5.2. Waist circumference men =102 cm, women =88 cm
- •5.6. Lack of physical exercise, 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)
- •5.7. Depression
- •5.7.1. Currently on anti-depressive medication or receiving psychotherapy for depression
- •5.7.2. History of treatment (i.e. drug therapy or psychotherapy) for depression OR Manifest cardiovascular disease, as diagnosed by specialist or general practitioner
- •Previous inclusion criteria:
- •1. Age =50 years =75 years
- •2. Basic level of literacy in Dutch
- •3. Possession of a smartphone
- •4. Turkish or South-Asian Surinamese background; OR Dutch background with low SES, operationalised using educational level and occupational status
- •5. Increased risk of dementia based on = one dementia risk factor defined as:
- •5.1. Hypertension, defined by any of the following:
- •5.1.1. Diagnosis by specialist or general practitioner.
- •5.1.2. Currently on anti-hypertensive drugs.
- •5.1.3. Baseline blood pressure: =140/90 mmHg;
- •5.2. Dyslipidaemia, defined by any of the following:
- •5.2.1. Diagnosis by specialist or general practitioner
- •5.2.2. Use of lipid-lowering drugs
- •5.2.3. Baseline total cholesterol =5.0 mmol/L
- •5.3. Diabetes mellitus, defined by any of the following:
- •5.3.1. Diagnosis by specialist or general practitioner
- •5.3.2. Use of any blood glucose-lowering medication
- •5.4. Active smoking (use of any sort of tobacco in any quantity)
- •5.5. Overweight, defined by any of the following:
- •5.5.1. Body mass index (BMI) =25 kg/m²
- •5.5.2. Waist circumference men =102 cm, women =88 cm
- •5.6. Lack of physical exercise, 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)
- •5.7. Depression
- •5.7.1. Current depression
- •5.7.2. Currently on anti-depressive medication or receiving psychotherapy for depression
- 另有 1 项未显示
排除标准
- •1. Diagnosed with dementia by a specialist or general practitioner
- •2. A score below 21 on the Rowland Universal Dementia Assessment Scale (RUDAS) validated dementia screening method specifically developed to be less susceptible to cultural, linguistic, and educational biases
- •3. Any condition expected to limit 12 months of compliance and follow-up, including metastasised malignancy or other terminal illness
- •4. Any impairment interfering with the operation of a smartphone
- •5. Participating in another RCT on lifestyle behavioural change
- •6. Present alcohol or illicit drug abuse impairing study participation
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