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临床试验/CTRI/2025/01/079470
CTRI/2025/01/079470招募中不适用

Development and Application of Frailty Management Model for Community Dwelling Elderly

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2025年3月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
388
试验地点
1
主要终点
1.Frailty: It will be assessed by FAST scale both categorical and continuous assessment.

研究概览

简要总结

Rationale: Frailty is one of the common geriatric syndromes and is a major challenge for the healthcare system. In our country, around 1/4th of older adults in rural areas are suffering from frailty (prevalence 24.7%–38.8%). Novelty: This proposal addresses the development of a frailty management model and its implementation among community-dwelling elderly people. Objectives: To develop & implement a frailty management model for community-dwelling elderly and to assess the effectiveness of this model. Methods: The study will be conducted in both urban and rural areas of West Bengal. In the first phase, from the available literature and evidence, a frailty management model will be prepared with the help of related stakeholders like geriatric specialists, nutrition specialists, neuromedicine specialists, physical medicine specialists, mental health specialists & public health specialists. After that, the proposed model will be validated by related experts by using the Delphi technique (qualitative). In the second phase, the prepared model will be implemented among community-dwelling elderly participants by implementation research design involving related stakeholders like family members, Urban Accredited Social Health Activists, ASHA, ANM, and CHO. In the third phase, the outcome of this frailty management model will be assessed on selected variables post-intervention 6 months and 12 months by quantitative assessment. Expected outcome: Development of a frailty management model for community-dwelling elderly population (robust, pre-frail & frail) in a modular format for an Indian setting and its implementation by training related healthcare workers and caregivers. The effectiveness of this frailty management model will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Subjects aged 60 years or more residing in the study area permanently for more than 2 years
  • Ability to speak and understand command.

排除标准

  • Elderly subjects having cognitive impairment
  • Elderly subjects with some specific diseases that would restrict them for dietary and physical activity like heart disease, end-stage kidney disease, cancer, visual and hearing impairments, severe bone and joint diseases (e.g., severe osteoporosis, severe knee, or shoulder joint degeneration).

结局指标

主要结局

1.Frailty: It will be assessed by FAST scale both categorical and continuous assessment.

时间窗: Baseline, 3 months, 6 months

2.Fried frailty index: It encompasses components like nutritional status, physical activity, mobility, strength, energy. Its score ranges from 0 to 5. It identifies three categories as robust, pre-frail and frail.

时间窗: Baseline, 3 months, 6 months

3.Clinical frailty scale: It indicates overall level of fitness or frailty.

时间窗: Baseline, 3 months, 6 months

次要结局

  • Nutritional status: Nutritional status will be assessed by MNA scale. Final result will be compared with baseline nutritional assessment of the participants(Baseline, 3 months, 6 months)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Indranil Saha

ICMR Centre for Ageing and Mental Health. Indian Council of Medical Research

研究点 (1)

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