Effect of Ageing on Interpretation of Disease Activity Measures and on Cognition, Physical Activity and Performance in Patients With Rheumatic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Age-specific reference curve Routine Assessment of Patient Index Data (RAPID)3 / Health Assessment Questionnaire (HAQ)2
研究概览
简要总结
The primary objective of the STAR study is to investigate how measures of disease activity and measures for cognition, physical activity and performance behave in ageing population controls and patients with rheumatoid arthritis (RA). If an differential effect of age on outcome over time is apparent, the presence of an inclination point will be assessed. The secondary objective is to investigate additional factors (e.g. lifestyle factors) that might explain any differences between ageing controls and RA patients.
The STAR study is an observational cross-sectional matched case-control study including 420 RA patients and 420 population controls between 55-85 years of age, stratified by five year intervals. All participants will complete generic and RA-specific questionnaires. A subset of 180 participants will be visiting the research center for physical examination and performance tests. Expected outcomes include practical age-specific reference curves that will be constructed for a selection of outcomes (e.g. DAS28).
It is expected that as RA is characterized by tender and painful joints, e.g. the number of tender joints has a higher starting point in RA patients than in the general population. This will most likely increase in both groups with age, although the general population may catch up at an older age. Measures of cognitive status may show a steeper decline with age in RA patients compared to the general population. Measures of physical activity and performance will presumably have a worse starting point in RA patients than in the general population, and might show a steep decline with age. The general population might however catch up with the patients with RA. Most probably, age will not be the only factor explaining 'worse' outcomes in both RA patients and the general population. Other factors such as lifestyle factors (e.g. smoking, diet, BMI, occupation) and comorbidities will probably play a role.
详细描述
Rationale:
As the population ages and the lifespan of people with rheumatoid arthritis (RA) extends, more insight into the effect of ageing on RA is needed. Currently, it is unclear whether ageing has an impact on the interpretation of disease activity measures, specifically the (components of the) DAS28. In addition, the effect of RA on cognitive function, physical activity and performance, three outcomes that will influence treatment decisions, is underinvestigated.
Objectives:
The objectives of this study are to gain insight into the effect of ageing on the result of disease activity measures, decline in cognition, physical activity and performance. A first step towards such understanding is construction of population reference curves in function of age. These curves can be used to discern whether the change in an outcome measure can be explained by age. If age is the only important factor, a similar change in the age-specific curve of both the population and RA patients would be observed. In case of differences in the curve inclination point, it is of interest exploring variables explaining such differences (e.g. lifestyle factors).
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subject is the spouse/partner of the included RA patient.
- •Have severe comorbidity and the treating rheumatologist and/or research team decides they should not be included in the study because of health reasons.
- •A diagnosis of dementia or mental incompetency is always reason for exclusion.
- •Persons of whom the research team estimates that his/her life expectancy is less than 2 years.
- •Do not understand the Dutch language and/or are notable to understand the study information.
结局指标
主要结局
Age-specific reference curve Routine Assessment of Patient Index Data (RAPID)3 / Health Assessment Questionnaire (HAQ)2
时间窗: Day 1
Age-specific reference curve for question 3 and 6 of the RAPID3/Multidimensional HAQ2. The RAPID3 scores vary between 0-30, where higher scores indicate poorer status.
Age-specific reference curve Disease Activity Score (DAS)28
时间窗: Day 1
Age-specific reference curve for components of the DAS28 (in subgroup). The DAS28 refers to 28 joints that examined in this assessment. Scores vary between 0-10, where higher DAS28 scores indicate a higher disease activity.
Age-specific reference curve Telephone Interview Cognitive Status (TICS)
时间窗: Day 1
Age-specific reference curve for the TICS. Total scores vary between 0-50, where a score below \<34 or \<28 may indicate a neurocognitive disorder as mild cognitive impairment (MCI) or dementia.
Age-specific reference curve Health Assessment Questionnaire (HAQ)
时间窗: Day 1
Age-specific reference curve for the HAQ. The HAQ is a questionnaire including 20 items in eight domains that measure difficulties in performing daily activities, where each question is rated on a scale from 0 to 3. A higher total score indicates higher disability in performing daily activities.
Age-specific reference curve timed stand chair test
时间窗: Day 1
Age-specific reference curve for the timed stand chair test (in subgroup).
次要结局
- Age-specific reference curves for the Groningen Frailty Indicator(Day 1)
- Age-specific reference curves for the General Anxiety Disorder (GAD)7(Day 1)
- Age-specific reference curves for the Patient Health Questionnaire (PHQ)9(Day 1)
- Age-specific reference curves for the Fried criteria(Day 1)
- Variables explaining differences between ageing in RA and population controls(Day 1)