Abdominal Aortic Aneurysms (AAA)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERConsultation
Consultations at a specialist surgical nurse-led clinic
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who received endovascular treatment for abdominal aortic aneurysm. * patients who could understand and communicate in Swedish.
Exclusion criteria
* cognitive impairment or language impairment that prevents communication and informed consent. * patients who did not receive endovascular treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Education Impact Questionnaire (HeiQ) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complementary questions for sexual function | from enrollment to 12 month after enrollment | Three complementary content-specific items were added to investigate specific contextual aspects not covered by the MSF-4 questionnaire as follows: one question if the participants had received information regarding potential procedure-related effects on sexual health and function (with a binary yes/no answer), one question about the perceived satisfaction with the provided information (with a binary yes/no answer), and one question about experiencing concern during sexual activity (with a binary yes/no answer). |
| Laboratory analysis - Cholesterol | from enrollment to 12 month after enrollment | blood analysis in mmol/L |
| Laboratory analysis - Triglycerids | from enrollment to 12 month after enrollment | blood analysis in mmol/L |
| Laboratory analysis - High density lipoprotein (HDL) | from enrollment to 12 month after enrollment | blood analysis in mmol/L |
| EuroQol Five Dimension (EQ-5D-3L) | from enrollment to 12 month after enrollment | standardized instrument designed to measure health outcomes that also has been commonly utilized in health economic analysis. An overall classification of perceived health is measured with a visual analog scale where 0 represents the worst possible imaginable health and 100 represents the best possible imaginable health. Health is further classified in five different dimensions: 1. mobility, 2. self-care, 3. daily activities, 4. pain/discomfort, and 5. depression/anxiety. These dimensions can be graded differently depending on what iteration of the instrument is being used. The present study used the three-scale step level version (EQ-5D-3L), with the alternatives no problems, some/moderate problems, and extreme problems for each dimension. |
| Laboratory analysis - Plasma glucose | from enrollment to 12 month after enrollment | blood analysis in mmol/L |
| Systolic blood pressure | from enrollment to 12 month after enrollment | measured in mmHg |
| Diastolic blood pressure | from enrollment to 12 month after enrollment | measured in mmHg |
| Laboratory analysis - Low density lipoprotein (LDL) | from enrollment to 12 month after enrollment | blood analysis in mmol/L |
| Complementary questions for the intervention | from enrollment to 12 month after enrollment | Four complementary items were used to further evaluate the effects of the intervention in the form of visual analog scales: 1. degree of perceived understanding of the diagnosis (1= not at all and 100 = understands completely), 2. degree of perceived understanding of the purpose of postoperative medical imaging examinations (1 = not at all and 100 = understands completely), 3. degree of desire for additional information regarding their disease (0 = no, it is enough and 100 = yes, much more), 4. degree of perceived concern about treated AAA (0 = never and 100 = all the time). |
Outcome results
None listed