Effectiveness and Implementation of a Primary Healthcare Intervention for Screening and Management of Multimorbidity and Frailty among Urban Older Adults of Bhubaneswar: The Multi-FrAME Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Health-related quality of life (HRQoL)
研究概览
简要总结
Rationale: Population ageing in low-and middle-income countries (LMICs) such as India has led to a rise in multimorbidity and frailty which have a bidirectional association affecting the quality of life. However, lack of specific intervention prohibits these individuals from getting additional support beyond disease oriented standard care. Novelty: There is a paucity of evidence on interventions for multimorbidity and frailty in low-and middle income settings which necessitates the development and testing of such an intervention and evaluating its implementation at primary healthcare levels. Objectives: To co-design and test the effectiveness of a primary healthcare intervention package for multimorbidity and frailty assessment & management among elderly (Multi-FrAME) on progression of frailty, functional ability, and patient-reported outcome measures (health-related quality of life, healthcare utilization, and life satisfaction). We will also evaluate the fidelity, acceptability, adoption, and sustainability of Multi-FrAME intervention. Methods: We propose the development and testing the effectiveness and implementation of a primary care based Multi-FrAME intervention package, by following three stages: a) Intervention Development, b) testing effectiveness of the intervention, c) implementation assessment. A Cluster Randomized Controlled Trial where we will randomly allocate the Health and Wellness Centers (HWCs) in Bhubaneswar city into intervention and control groups would be undertaken. Participants (≥60 years) residing within urban area of Bhubaneswar with multimorbidity and some degree of frailty will be included. Expected Outcome: This study will develop a primary care based intervention package, and generate evidence on its effectiveness and implementability which could further be deployed in other countries/similar settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants should be residing within the urban area of Bhubaneswar city with multimorbidity
- •Participants are willing to participate in the study by providing informed written consent and agree to be followed up for two years.
排除标准
- •Participants with
- •Severe cognitive impairment
- •Seriously ill/bed-ridden patients.
结局指标
主要结局
Health-related quality of life (HRQoL)
时间窗: 6 & 12 months
次要结局
- Frailty progression, functional ability, healthcare(utilization, healthcare)
研究者
Dr JAYA SINGH KSHATRI
ICMR Regional Medical Research Centre
