Clinical trial NCT03157973: Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
Official title: Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Keywords: Information Literacy
Nursing Care
Social Support
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2017-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
Secondary outcomes:
measure: SF12
timeFrame: 12 months
measure: Quality from the patient's perspective (QPP)
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Vascular Surgery, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Rebecka Hultgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson O, Stenman M, Letterstal A, Hultgren R. A randomized clinical trial of an eHealth intervention on anxiety in patients undergoing abdominal aortic aneurysm surgery. Br J Surg. 2021 Aug 19;108(8):917-924. doi: 10.1093/bjs/znab151.