"Mild Cognitive Impairmentamong Community DwellingAdults: Prevalence, Associated Factors, and Feasibilityof a Multidomain Intervention Package for Preventing Cognitive Decline."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Cognitive ability will be assessed using Addenbrookes cognitive examination
研究概览
简要总结
Study population: Older adults, 60-75 years of age with mild cognitive impairment.
Study sample: Randomly selectedolder adults, in the age group of 60-75 years with mild cognitive impairment in Tiruvalla taluk of Pathanamthitta district in Kerala.
Sample size:
Various studies reported a difference of 0.01 to 0.03 in Z scores between the intervention and control group with standard deviation 0.002 to 0.042 (3-4). Also, their sample size ranges from 165 to 600. Therefore, we calculated the sample size for the present study using the parameters, difference in mean z -score as 0.01 and standard deviation 0.03 for a 90 % power and 5% type 1 error. We used the sample size formula to calculate the sample size for the difference in mean. We calculated the sample size as 189 and an expected possibility of 10% drop out. Based on this, we decided to enroll 210 as minimum required participants in our study in each arm.
Sampling procedure:
Our sampling area consists of 54 wards from Tiruvalla Taluk of Pathanamthitta district. From these wards, 15 urban and 5 (total 20 wards) ruralwards will be randomly picked. Identified, consented adults (60 to 75 year old) will be screened using the study tool and classify them according to the various levels (mild, moderate, severe) of cognitive impairment, lead to the burden assessment as an initial phase of the study. We randomly divide the selected 20 wards in to 10 each, say A and B and the flipped coin will decide which one is intervention and control group. Further, those diagnosed as Mild Cognitive Impairment (MCI), 21 each will be randomly enrolled into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 60.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals between 60-75 years old, willing to participate and comply with all the study evaluation and intervention procedures CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of 6 points or higher Mini Mental State Examination, MMSE <26 and >20.
排除标准
- •Barthel index <
- •Geriatric Depression Scale ≥ 9 Dementia or Moderate Cognitive impairment (MMSE < 20).
- •Disorders that may affect safe involvement in the intervention (eg, malignancy, symptomatic cardiovascular disease, Large vessel stroke in the past two years, History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months, revascularisation within 1 year previously, severe loss of vision, hearing, or communicative ability) Coincident participation in another intervention trial.
- •Recent (< 3 months) bone fracture.
- •History of hip fracture, joint replacement, or spinal surgery in the last 6 months Clinically significant abnormalities in laboratory blood tests as per the judgment of the site study clinician.
结局指标
主要结局
Cognitive ability will be assessed using Addenbrookes cognitive examination
时间窗: Cognitive ability will be assessed at baseline, 6 months, 12 months and 24 months.
次要结局
- Depresiion, quality of life , ADL(measurements will be made at baseline, 12 months & 24 months)