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

Not Applicable

Completed

• Conditions: Aortic Aneurysm
• Interventions: Other: Education intervention

• Registration Number: NCT03157973
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education intervention	Education intervention	-

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	12 months	A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.

Secondary Outcome Measures

Name	Time	Method
SF12	12 months	A 12-item questionnaire that measures 8 dimensions of physical and mental health.
Quality from the patient's perspective (QPP)	12 months	A validated self-assessment scale measuring patient perceived quality of care.

Trial Locations

Locations (1)

Department of Vascular Surgery, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden