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临床试验/NCT06904690
NCT06904690招募中不适用

JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes

Istituto Nazionale di Ricovero e Cura per Anziani2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
eHealth literacy

研究概览

简要总结

The JACARDI trial is a multicenter study involving an educational training, with the general objective to improve the eHealth of older adults in relation to the management of type 2 diabetes.

详细描述

The JACARDI trial is a multicentric study organized as a blended didactic and interactive educational training, with the general objective to improve the eHealth of older adults in relation to the management of type 2 diabetes, thus contributing to independent living, and reduce risks of negative consequences for the health status and quality of life.

The trial will be preceded by a pre-study, needed to personalize and finalize the contents of the training, together with the beneficiaries of the study. In particular, during the pre-study, a population with similar characteristics of the target group will be involved in focus groups to refine the contents and practicalities of the training before the recruitment starts.

The primary end-point of the JACARDI trial is the improvement of the eHealth literacy after the conduction of the training, to be measured through the eHEALS scale, after 10 weeks of training. The training consisting of 5 modules and will be conducted over 10 weeks (one session every other week), with each session lasting an average of 90 minutes.

研究设计

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

入排标准

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

入选标准

  • •Low eHealth literacy (eHeals scale ≤ 29)
  • •No acute or untreated medical problems
  • •Mini Mental State Examination (MMSE) ≥ 24
  • •Geriatric Depression Scale (GDS) < 2

排除标准

  • •A myocardial infarction or stroke within 6 months
  • •Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility
  • •Uncontrolled hypertension
  • •Advanced Parkinson's disease or other neuromuscular disorder
  • •Metastatic cancer or immunosuppressive therapy
  • •Significant visual or hearing impairment

研究组 & 干预措施

diabetic subjects

Experimental

Subjects with type 2 diabetes who have low eHealth literacy.

干预措施: Educational training (Other)

结局指标

主要结局

eHealth literacy

时间窗: Baseline and 10, 14 and 34 weeks later

Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.

次要结局

  • Health-related quality of life(Baseline and 10, 14 and 34 weeks later)
  • Health literacy(Baseline and 10, 14 and 34 weeks later)
  • Psychological well-being(Baseline and 10, 14 and 34 weeks later)
  • Diabetes related emotional distress(Baseline and 10, 14 and 34 weeks later)

研究者

发起方
Istituto Nazionale di Ricovero e Cura per Anziani
申办方类型
Other
责任方
Sponsor

研究点 (2)

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