Effect of Nurse-led Education on Health, Quality of Life and Sexual Health

NCT06986252 | Terminated DMC

• 1 other identifier: DNR064-13
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Aortic Aneurysms (AAA)

Outcome Measures

Primary Outcomes (2)

• 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: 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.

  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.

  from enrollment to 12 month after enrollment

Secondary Outcomes (10)

• 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

the intervention group received standard care plus they were also offered two consultations at a specialist surgical nurse-led clinic

Other: Consultation

Control

NO INTERVENTION

The control group received standard care.

Interventions

Consultation OTHER

Consultations at a specialist surgical nurse-led clinic

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who received endovascular treatment for abdominal aortic aneurysm.
• patients who could understand and communicate in Swedish.

You may not qualify if:

• cognitive impairment or language impairment that prevents communication and informed consent.
• patients who did not receive endovascular treatment.

Sponsors & Collaborators

• Göteborg University: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Monica Pettersson, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: May 22, 2025
• Study Start: April 20, 2015
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: May 22, 2025

Record last verified: 2025-04