Effect of Nurse-led Education on Health, Quality of Life and Sexual Health for Patients Undergoing Endovascular Intervention for Abdominal Aortic Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 主要终点
- Health Education Impact Questionnaire (HeiQ)
研究概览
简要总结
The main hypothesis is that a nurse-led education provided to patients who received endovascular treatment due to enlarged abdominal aorta would present a difference in perceived health, quality of life and sexual health.
详细描述
A longitudinal, prospective single-centre randomized control trial to evaluate the effects of a nurse-led educational intervention for patients undergoing endovascular intervention for abdominal aortic aneurysm.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •patients who received endovascular treatment for abdominal aortic aneurysm.
- •patients who could understand and communicate in Swedish.
排除标准
- •cognitive impairment or language impairment that prevents communication and informed consent.
- •patients who did not receive endovascular treatment.
研究组 & 干预措施
Intervention
the intervention group received standard care plus they were also offered two consultations at a specialist surgical nurse-led clinic
干预措施: Consultation (Other)
Control
The control group received standard care.
结局指标
主要结局
Health Education Impact Questionnaire (HeiQ)
时间窗: from enrollment to 12 month after enrollment
A generic instrument (40 items), that measures health effects after education. The instrument consists of eight scales that measure different perceived health-related aspects: 1. health directed activities, 2. positive and active engagement in life, 3. emotional distress, 4. self-monitoring and insight, 5. Constructive attitudes and approaches, 6. skills and technique acquisition, 7. social integration and support, and 8. health service navigation. The response options for each item are scored 1-4: "strongly disagree," "disagree," "agree" and "strongly agree." The HeiQ-scales are scored by summarizing within scale item scores, followed by dividing the sum with the number of scale items. A higher number represents better outcomes in all scales except for the emotional distress scale, where a higher score represents worse outcome.
Male Sexual Function-4 Questionnaire
时间窗: from enrollment to 12 month after enrollment
Questionnaire consisting of four items designed to asses aspects of sexual function, as well as perception of overall sexual quality of life. The four items include interest in sex, achieving orgasm, quality of erection, and achieving ejaculation. Each item is scored on a six-point Likert scale ranging from 0 to 5. The raw scores are linearly transformed to a global sex life index ranging from 0 to 100, where a lower score indicates better preserved sexual function. For female participants, four specific items related to female sexual function were used, based on MSF-4 and derived from a previous study that investigated female patients undergoing colorectal surgery; first two items were interest in sex and achieving orgasm and both used a six-point Likert scale ranging from 0 to 5 where a lower score indicates better outcome. The second two items were problems with insufficient vaginal moisture and changes in the vaginal sense postoperatively, both items used binary yes/no answers.
次要结局
- Diastolic blood pressure(from enrollment to 12 month after enrollment)
- Complementary questions for sexual function(from enrollment to 12 month after enrollment)
- Laboratory analysis - Cholesterol(from enrollment to 12 month after enrollment)
- Laboratory analysis - Triglycerids(from enrollment to 12 month after enrollment)
- Laboratory analysis - High density lipoprotein (HDL)(from enrollment to 12 month after enrollment)
- Laboratory analysis - Low density lipoprotein (LDL)(from enrollment to 12 month after enrollment)
- Laboratory analysis - Plasma glucose(from enrollment to 12 month after enrollment)
- Systolic blood pressure(from enrollment to 12 month after enrollment)
- EuroQol Five Dimension (EQ-5D-3L)(from enrollment to 12 month after enrollment)
- Complementary questions for the intervention(from enrollment to 12 month after enrollment)
