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临床试验/NCT06320652
NCT06320652招募中不适用

Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation - a Study on Health Literacy, Health Related Quality of Life, and Family Support

Copenhagen University Hospital, Hvidovre2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
2
主要终点
Health Literacy Questonnaire

研究概览

简要总结

The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses.

详细描述

The project is designed inspired by The Complex Intervention Framework (MRC-Guidelines) combined with a patient and family participatory design. The project will consist of three sub-studies. The first study is a co-creation development of a model for the cardiac telerehabilitation intervention. The second study is a quasi-experimental study with a quantitative comparison of the group receiving the cardiac telerehabilitation intervention and control group. The third study will be a descriptive qualitative study which aim to investigate patient's experience with CTR using participant observation and individual interview or dyadic interview.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Patients and their family members affiliated with the Department of Cardiology at Amager and Hvidovre Hospital and attending cardiac rehabilitation.
  • Patients diagnosed with ischemic heart disease, heart failure, persistent atrial fibrillation, and cardiac valve surgery.

排除标准

  • Patients with substantial language barriers and limited cognitive function.
  • Patients who can't use a smart phone, tablet, or computer.

结局指标

主要结局

Health Literacy Questonnaire

时间窗: 3 months

Health literacy is investigated through instruments such as the Health Literacy Questionnaire (HQL). The HLQ contains 44 qustions that cover nine conceptually distinct areas of Health Literacy. Response options for each scale are determined by the content and nature of the items. For scale 1-5 four point ordinal response options are used (strongly disagree, disagree, agree and strongly agree), while for scales 6-9 five-point ordinal response options are used (cannot do, very difficult, quite difficult, quite easy and very easy). HLQ scale scores are calculated as unit-weighted sums of the constituents items averaged by the number of items in the scale such that the nominal range of the scale scores are 1-4 for scale 1-5 and 1-5 for scale 6-9. A low score means worse outcome and a high score means better outcome.

次要结局

  • The European Quality of life five dimensions questionnaire(3 months)
  • The eHealth Literacy Questionnaire(3 months)
  • The Iceland-Family Perceived Support Questionnaire(3 months)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Cecilie Tjustrup

PhD student, MSc, RN

Copenhagen University Hospital, Hvidovre

研究点 (2)

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