Abdominal Aortic Aneurysms (AAA)NCT06986252
Effect of Nurse-led Education on Health, Quality of Life and Sexual Health
A study testing Consultation in people with Abdominal Aortic Aneurysms (AAA), run by Göteborg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA)
- What is being tested?
- Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2015to 24 May 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who received endovascular treatment for abdominal aortic aneurysm.
- patients who could understand and communicate in Swedish.
Who cannot join
- cognitive impairment or language impairment that prevents communication and informed consent.
- patients who did not receive endovascular treatment.
About this study
Official title: Effect of Nurse-led Education on Health, Quality of Life and Sexual Health for Patients Undergoing Endovascular Intervention for Abdominal Aortic Aneurysm
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Being tested
- Consultation
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsultationOther
Consultations at a specialist surgical nurse-led clinic
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | the intervention group received standard care plus they were also offered two consultations at a specialist surgical nurse-led clinic Receives: Other: Consultation |
| Control | No intervention | The control group received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Education Impact Questionnaire (HeiQ)
A generic instrument (40 items), that measures health effects after education.
The instrument consists of eight scales that measure different perceived health-related aspects:
- 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.
Measured: from enrollment to 12 month after enrollment
Male Sexual Function-4 Questionnaire
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.
Measured: from enrollment to 12 month after enrollment
Secondary outcomes (10)
EuroQol Five Dimension (EQ-5D-3L)
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.
Measured: from enrollment to 12 month after enrollment
Complementary questions for the intervention
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).
Measured: from enrollment to 12 month after enrollment
Complementary questions for sexual function
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).
Measured: from enrollment to 12 month after enrollment
Laboratory analysis - Cholesterol
blood analysis in mmol/L
Measured: from enrollment to 12 month after enrollment
Laboratory analysis - Triglycerids
blood analysis in mmol/L
Measured: from enrollment to 12 month after enrollment
Laboratory analysis - High density lipoprotein (HDL)
blood analysis in mmol/L
Measured: from enrollment to 12 month after enrollment
Laboratory analysis - Low density lipoprotein (LDL)
blood analysis in mmol/L
Measured: from enrollment to 12 month after enrollment
Laboratory analysis - Plasma glucose
blood analysis in mmol/L
Measured: from enrollment to 12 month after enrollment
Systolic blood pressure
measured in mmHg
Measured: from enrollment to 12 month after enrollment
Diastolic blood pressure
measured in mmHg
Measured: from enrollment to 12 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start20 Apr 2015
- Primary completion24 May 2019
- Study completion24 May 2019
Why it stopped: Surgical specialist nurses appointed to the intervention resigned from employment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysms (AAA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Pettersson, Professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986252
- Sponsor's protocol ID
- DNR064-13
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nilsson J, Nordanstig J, Ringdal M, Skoog P, Pettersson ME. Impact of nurse-led postoperative education on health outcomes following endovascular aortic repair: a randomized trial. Sci Rep. 2026 May 23;16(1):16009. doi: 10.1038/s41598-026-54460-w.
PubMed 42174117