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临床试验/NCT02832739
NCT02832739Unknown不适用

Exploring Acceptance and Outcomes of an ICT-based Self-management Support System for Community-dwelling Older Adults With Chronic Diseases and Informal Caregivers: USECARE Study Protocol

Assuta Medical Center2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Level of and potential changes in technology acceptance in participants

研究概览

简要总结

The aim of the USECARE project is to improve and test SENACA, an ICT-based self-management support system for chronically ill patients and informal caregivers. 60 end-users will be instructed to use SENACA for approx. 3 months (in Israel and Norway). Amongst others, clinical and behavioural outcomes will be recorded. Additionally, SENACA's usability will be evaluated to determine its potential future scalability.

详细描述

In Switzerland, SENior health ACAdemy (SENACA, www.senaca.ch) has been developed by the European Medical Network EMN.

SENACA is a structured self-management support system with several interacting components, combining tele-monitoring devices and a solution for personalised health plans. This online support system's usability, the behaviour change techniques it builds on, modes of delivery and its effects on health-related behaviour, clinical and Quality-of-Life outcomes will be established in a larger group of end-users.

Testing the usability of SENACA and practical effectiveness of this intervention is the goal of this multi-national project USECARE (www.usecare.eu).

SENACA will be implemented in two countries (Israel and Norway ) via field test with community-dwelling older adults living with chronic conditions (i.e. diabetes, COPD, chronic heart failure) and their informal caregivers.

Key element of USECARE is a field-test including a study based upon pre-experimental design with three time point measurements and a pre-usability round. Multiple methods will be used to evaluate the usability and to observe clinical and process parameters before, during and after the implementation of the enhanced SENACA prototype.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Inclusion community-dwelling older adults (primary end-users):
  • •receive medical care for one or more of the following chronic diseases in hospital settings and outpatient clinics:
  • •Chronic Heart Failure (CHF, New York Heart Association NYHA IIIIIa);
  • •Diabetes Mellitus (DM, 6< HbA1c<9),
  • •Chronic Obstructive Pulmonary Disease (COPD, GOLD I-II)
  • •Special Orthopaedic Co-Morbidity (SOCM, after elective hip or knee replacement, health status temporarily destabilized respectively challenged, increased monitoring and formal/informal care).
  • •having support of an informal caregiver that is aged 18 years or older
  • •aged 50 years and older (primary end-users)
  • •Exclusion community-dwelling older adults (primary end-users):
  • •known illiteracy (reading and writing difficulties)
  • •lack of local language proficiency
  • •current major mental illness of moderate to severe level
  • •major acute illness or surgery in past 3 months (except elective hip / knee surgery for patients with SOCM)
  • •participation in another intervention study
  • •Inclusion informal caregivers (secondary end-users):
  • •aged 18 years or older
  • •named by primary end-user as designated informal caregiver providing physical, emotional and/or social support for him or her
  • •Both inclusion criteria primary and secondary end-users:
  • •written informed consent
  • •adequate functional, sensory and cognitive abilities to use the SENACA system

排除标准

  • •primary and secondary end-users:
  • •does not have a stable address of residence
  • •no internet/computer access
  • •inability to handle ICT-devices due to cognitive or functional disabilities

研究组 & 干预措施

SENACA - self-management support system

Experimental

Use of enhanced SENACA - ICT based self-management support system prototype by study participants at home for 75-100 days

干预措施: SENACA - ICT based self-management support system (Device)

结局指标

主要结局

Level of and potential changes in technology acceptance in participants

时间窗: Up to three months

Technology acceptance (usability) of system is measured by assessing participants' intention to use, perceived ease of use, perceived usefulness, technology experience, preference in using technology, errors, and user satisfaction. Instruments used are: Technology Acceptance Model (TAM), Post-Study System Usability Questionnaire (PSSUQ), all self-reported questionnaires. In addition, system errors will be reported (number and type of problems).

次要结局

  • Level of and potential changes in eHealth Literacy in participants(Up to three months)
  • Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L(Up to three months)
  • Level of and potential changes in self-efficacy of participants(Up to three months)
  • Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity(Up to three months)
  • Level of and potential changes in uptake and usage of the SENACA intervention by participants(Up to three months)
  • Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)(Up to three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Gindin

Director Geriatric Services

Assuta Medical Center

研究点 (2)

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