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临床试验/NCT05304975
NCT05304975已完成不适用

BRAIN-Diabetes: Border Region Area Lifestyle Intervention Study for Healthy Neurocognitive Ageing in Diabetes. A Feasibility Randomised Controlled Trial

Queen's University, Belfast1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Evaluation of recruitment strategies, retention, attrition rates and reasons for withdrawal for study participants in both intervention and control groups

研究概览

简要总结

The objective is to evaluate a culturally tailored adaptation of The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) protocol targeted for individuals with Type 2 diabetes mellitus (DM) living in the border areas of Ireland. The primary research question to be addressed is; what is the feasibility and acceptability of implementing a multicomponent intervention for the target population in a community setting in comparison to standard clinical care. The study protocol was informed by a phase 1 qualitative study (REC ref 19/NI/0011) involving the target population i.e. older people with Type 2 DM from the border areas of N Ireland and the Republic of Ireland and has been amended (version 2.0) in response to the coronavirus pandemic

详细描述

Dementia is the most frequent neurodegenerative condition and poses a major health burden with high socioeconomic costs. Attempts to find pharmacologic treatments have been largely unsuccessful, prompting a focus on interventions aimed at modifying risk factors for dementia that occur throughout the life course. In terms of risk factors for dementia, strongest support is for depression, (midlife) hypertension, physical inactivity, DM, (midlife) obesity, hyperlipidaemia, and smoking. The incidence of any dementia was approximately two-to three-fold higher in people with than in those without DM, leading to suggestions that interventions addressing lifestyle changes and DM treatment could be beneficial.

A number of intervention studies in DM have focused on reduction of cardiovascular outcomes. These results suggest that intensive treatment does not adversely affect patient-reported outcomes. There have been few cognition studies. Identification of cognitive domains most affected by DM can lead to targeted risk modification, possibly through lifestyle interventions (diet/physical activity) and may reduce risk of cognitive dysfunction and possibly dementia. An overview of cognitive testing in DM showed impairment in tests of executive function, working memory, psychomotor and attentional functions. Impairments of executive function and choice reaction time may have consequences for everyday functioning. Trail Making Task, Symbol Digit Modalities Test, Verbal Fluency Task and tests of reaction time and processing speed could be included as core components of test batteries in future intervention studies.

However there are few studies with a multifactorial intervention and cognition as an endpoint in DM.

FINGER showed that an intensive multi-domain lifestyle intervention programme (nutrition, exercise, cognitive stimulation and social activity, intensive vascular risk factor control) applied in older people (60-77 years) at higher risk for dementia produced significant cognitive benefits after 2 years.

There are concerns whether the intensive nature of the FINGER intervention are translatable/applicable to clinical practice in different healthcare systems. Further studies are required to evaluate the efficacy of multi-domain lifestyle interventions in targeted high-risk populations including a need to develop a practical and feasible program which is deliverable in community settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Type 2 Diabetes mellitus
  • aged ≥50 years
  • within five years of diagnosis
  • access to a computer, tablet or smartphone -

排除标准

  • conditions affecting safe engagement in the intervention (especially the exercise component)
  • insulin therapy
  • malignant diseases
  • major depression within 6 months
  • dementia/substantial cognitive decline
  • Mini Mental State Examination <20
  • symptomatic cardiovascular disease
  • revascularization within 1 year
  • severe loss of vision, hearing, or communicative ability
  • conditions preventing cooperation as judged by the study physician
  • coincident participation in any intervention trial. -

结局指标

主要结局

Evaluation of recruitment strategies, retention, attrition rates and reasons for withdrawal for study participants in both intervention and control groups

时间窗: at 6 months. T

This is a feasibility study. we need to collect data on recruitment strategies. We will maintain a record of how many people were contacted, how many consented, the numbers dropping out and the reasons for withdrawal

Determination of fidelity of implementation, feasibility and acceptability of the intervention

时间窗: at 6 months.

we will record subject compliance with the study intervention and the feasibility of that intervention. by a questionnaire

Generation of variability data on the primary outcome measure (cognition) from baseline to 6 months on which to base a formal power calculation for a large-scale trial

时间窗: 6 months.

Cognition will be assessed using CATCH COG

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Passmore

Professor

Queen's University, Belfast

研究点 (1)

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