跳至主要内容
临床试验/CTRI/2024/09/073487
CTRI/2024/09/073487尚未招募3 期

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

ICMR Regional Medical Research Centre1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2025年1月15日最近更新:

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

发起方
ICMR Regional Medical Research Centre
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr JAYA SINGH KSHATRI

ICMR Regional Medical Research Centre

研究点 (1)

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