Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm

Aortic Aneurysm Clinical Trial

Official title:

Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157973
• Other study ID #: Dnr 2016/1253-31/4
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 30, 2022

Study information

• Verified date: December 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of an eHealth tool and psychosocial support on anxiety, depression and health-related quality of life in patients undergoing surgical treatment for abdominal aortic aneurysm (AAA). Participants in the intervention group will receive access to the eHealth tool and structured follow-up with a contact nurse, the control group will receive standard of care.

Description:

Abdominal aortic anuerysm (AAA) is associated with a decreased health-related quality of life (HRQoL) both at diagnosis and during surgical treatment, although recent studies report somewhat contradictory results. In qualitative research, it has been shown that the health care system fails to meet the patients' information need, as well as their need for psychosocial support during the care process. The aim of this study is therefore to evaluate the effects of an intervention comprising an eHealth tool with individualized information in combination with structured follow-up with a contact nurse on anxiety, depression and HRQoL in patients undergoing surgical treatment for AAA. Patients who are planned for elective surgical treatment, fulfil the inclusion criteria and none of the exclusion criteria will fill out questionnaires. The control group will receive information and follow-up per institution's standard of care. The intervention group will be given access to the eHealth tool, containing individualized information about the condition, surgical procedure and self-care. They will also receive structured follow-up by a contact nurse at discharge, 3 and 12 months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Ability to speak and understand Swedish
• Planned for elective surgical repair of an abdominal aortic aneurysm

Exclusion Criteria:

• Severe visual impairment or blindness
• Severe hearing impairment or deafness
• Diagnosed dementia
• Medical condition with a suspected life expectancy of < 1 year.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Other:
• Education intervention
eHealth tool and standardized nurse-led follow-up.

Locations

Country	Name	City	State
Sweden	Department of Vascular Surgery, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS)	A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.	12 months
Secondary	SF12	A 12-item questionnaire that measures 8 dimensions of physical and mental health.	12 months
Secondary	Quality from the patient's perspective (QPP)	A validated self-assessment scale measuring patient perceived quality of care.	12 months