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临床试验/CTRI/2024/05/067088
CTRI/2024/05/067088尚未招募3 期

Implementation of contextualized clinical practice guidelines for motor rehabilitation post-stroke in India- the CLAIM INDIA study

Dorcas BC Gandhi1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月30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
10
试验地点
1
主要终点
Reach effectiveness adoption implementation sustainability the REAIM outcome

研究概览

简要总结

This 3 phased mixed methods study is aimed at studying the impact of clinical and implementation outcomes of a multi-component intervention on contextualized motor rehabilitation Clinical Practice Guidelines (CPGs) for stroke rehabilitation in India. Phase 1 will include a qualitative (focus group discussions), co-design method to contextualize existing stroke rehabilitation guidelines for the Indian context, following the methodology for contextualization provided by Grimmer etal. Phase 2 will include a 4-phased qualitative design (survey) to prioritize top recommendations from contextualized CPGs developed in Phase 1 that are most feasible and relevant to be implemented. This phase will also be co-design and based on a prioritization model followed in Australia by Lynch etal. Phase 3 will follow the Hybrid-2 implementation study design to  study the impact of implementing the prioritized recommendations from phase-2 across 2 tertiary hospitals in India. Outcomes will be: the RE-AIM i.e. Reach, Effectiveness, adoption, implementation & maintenance of the intervention/prioritized recommendations.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • For Phase 1: representatives from different Indian zones, rural/urban, public/private hospitals): if they have been practicing stroke rehabilitation as Neurologists/Physiatrists/PTs/OTs/ rehabilitation nurses/Social workers in India for a minimum of 10 years.
  • Persons with lived experience (PwLEs) will be included in the panel after due voluntary informed consent if they have had any type of stroke in the past 5 years and have availed rehabilitation service in India For Phase 2: Stroke experts in motor rehabilitation with clinical experience in India for a minimum of 10 years (equal balance between PTs, OTs, Neurologists, Physiatrists) Stroke researchers of motor rehabilitation working in India for a minimum of 10 years PwLE of stroke (subacute or chronic phases of stroke), representatives from stroke support organization in India Hospital and local administrators Local Policy advisors Social workers/community health worker/ASHA For Phase 3: for stroke rehab providers PTs employed in the SU at the 2 tertiary hospitals with responsibility of assessing, planning and delivering motor rehabilitation post-stroke OTs employed in the SU at the 2 tertiary hospitals with responsibility of assessing, planning and delivering motor rehabilitation post-stroke Inclusion criteria for Stroke PwLE Depending on the recommendation prioritized.

排除标准

  • Those unwilling or not fulfilling selection criteria.

结局指标

主要结局

Reach effectiveness adoption implementation sustainability the REAIM outcome

时间窗: 16th and 24th week post intervention

次要结局

未报告次要终点

研究者

发起方
Dorcas BC Gandhi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dorcas BC Gandhi

Christian Medical College and Hospital

研究点 (1)

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