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临床试验/NCT04450225
NCT04450225已完成不适用

Testing the Psychometric Properties of the Italian Version of the Reintegration to Normal Living Index in Complex Patients Discharge From Physical Medicine and Rehabilitation Unit: a Validation Study

Azienda USL Reggio Emilia - IRCCS2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2020年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
2
主要终点
Phase_1: to test the Content validity of the Reintegration to Normal Living Index

研究概览

简要总结

Since the post-acute phase, patients have occupational needs related to social reintegration, that improve the autonomy, social roles in family, at work and in the community.

Unmet needs could lead to a lower level of social reintegration. Healthcare professionals should be able to recognize the level of social reintegration of complex patients discharged from the Physical Medicine Rehabilitation (PRM) unit with the aim to identify those who need intervention aimed at improving social reintegration.

The preliminary Italian version of the RNL index (RNLI) will describe the social reintegration level of the target population, once its psychometric properties will be tested.

详细描述

The investigators will recruit three groups of participants to test the psychometric properties of the Italian version of the RNLI: complex patients, caregivers and stakeholders.

Phase_1: to test the Content validity. The content validity will be tested on 10 complex patients and 10 stakeholders, who will assess the clarity and relevance of the RNLI items, respectively. In this phase, complex patients are hospitalized in the PMR unit.

From this first phase, the investigators will obtain the preliminary Italian version of the RNLI to test its psychometric properties.

Phase_2: to test the Reliability, Construct validity and Responsiveness. During the hospitalization in the PMR unit, 138 patients and their caregivers will be recruited. During this phase, the investigators will detect the important occupational activities of complex patients enrolled through a semi-structured interview conducted in person.

After discharge, the investigators will contact the patients and their caregivers by telephone at different times (T0, T1 and T2) to test the following psychometric properties through the administration of the Italian version of the RNLI and the Canadian Occupational Performance Measure (COPM). Caregiver will have to answer to the RNLI as a proxy for the patient.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For patient:
  • Inclusion Criteria:
  • hospitalized in the PMR unit of AUSL-IRCCS of Reggio Emilia
  • Rehabilitation Complexity Scale Extended ≥ 9
  • Discharge at home

排除标准

  • language barrier
  • comorbidities that limit communication and/or collaboration (eg aphasia, dementia, cognitive deficits, severe anxious-depressive syndromes pre-existent to hospitalization, etc.)
  • discharge in residential structures, retirement homes or long-term care or transferred to acute wards for complications.
  • For caregiver:
  • main caregivers of the patients enrolled
  • For stakeholders:
  • a rehabilitation healthcare professional with at least 3 years of clinical experience in rehabilitation and reintegration into the living environment of highly complex patients

结局指标

主要结局

Phase_1: to test the Content validity of the Reintegration to Normal Living Index

时间窗: 3 months

A group of complex patients and stakeholders will report the clarity and the relevance of the items of the Reintegration to Normal Living Index (RNLI), respectively. Thus, the content validity of the RNLI will be tested.

次要结局

  • Phase_2: to test the Reliability, Construct validity and Responsivness of the Reintegration to Normal Living Index(19 months)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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