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临床试验/NCT02663856
NCT02663856Unknown不适用

My Smart Age With HIV (MySAwH): Smartphone Self-assessment of Frailty and Information - Communication Technology to Promote Healthy Ageing in HIV.

University of Modena and Reggio Emilia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Measure Multi-morbidity

研究概览

简要总结

Understanding the complexity of aging and frailty in chronic HIV infection motivated Italian team members to begin to build a frailty index (FI) including 37 health variables at the Modena HIV Metabolic Clinic (MHMC). The validation of FI in HIV patients have been recently published, and more data comparing FI in HIV infected vs un-infected people, have been presented at international meeting and are at present submitted for publication.

The research consortium (MHMC, HCC and HHMP) of this study was motivated to begin preliminary work in consideration of the similar multidisciplinary approach in Ageing care and capacity to address health status in ageing HIV patients using shared definitions of co-morbidities, multi-morbidity and measures of Physical Function and Cognition impairment, disability and quality of life. The investigators wanted to overcome the major criticism intrinsic in the FI, that is the needs to collects many variables not easily available in most HIV centres. The the investigators approach is to make patient living with HIV (PLWH), be the source of health variables taking advantage of information and communication technologies available with smart phones and fitness tracking device, collecting physiological parameters and patient related outcomes.

详细描述

In this study the investigators plan to empower elderly HIV patients via health promotion, assessing reduction in health deficit and improvement in quality of life using My Smart Age (MySAwH) application.

MySAwH is an interactive mobile application designed to empower elderly HIV patients in health promotion through self assessment of ageing transition using a FI. FI is generated from health variables which include physical function data routinely collected by fitness tracking devices, Ecological momentary assessment data collected with smart phones and Physician health data collected during patient visits. The change in frailty index over time describes health transition. Although health generally worsens with age, the relationship between aging and health is dynamic and periodic improvement and stability in frailty index may be the result of the patients engagement in health promotion and improved life style.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • HIV infection on ART
  • HIV1-RNA<40 c/mL for at least 6 months
  • Age stratification:
  • 50 pts (per centre) aged 50-64 years
  • 50 pts (per centre) aged ≥ 65 years
  • Routine access to a smart phone and willingness to use the fitness tracking device
  • Willingness to be trained to use an interactive mobile application

排除标准

  • 未提供

结局指标

主要结局

Measure Multi-morbidity

时间窗: 18 months

Assed by physician, based on the presence of 2 or more co-morbidities (hypertension, diabetes, cardiovascular disease, etc)

Measure quality of life

时间窗: 18 months

Assed using quality of life questionnaire

Measure change of frailty index

时间窗: 18 months

Assed by MySAwH application

Measure disability

时间窗: 18 months

Assed using disability questionnaire

Measure Physical Function

时间窗: 18 months

Assed using a Short Physical Performance Battery

Measure Cognition impairment

时间窗: 18 months

Assed using neurocognitive tests

次要结局

未报告次要终点

研究者

发起方
University of Modena and Reggio Emilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Guaraldi

MD

University of Modena and Reggio Emilia

研究点 (1)

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