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Clinical Trials/NCT03157973
NCT03157973
Completed
Not Applicable

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

Karolinska University Hospital1 site in 1 country120 target enrollmentDecember 2016
ConditionsAortic Aneurysm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Aneurysm
Sponsor
Karolinska University Hospital
Enrollment
120
Locations
1
Primary Endpoint
Hospital Anxiety and Depression Scale (HADS)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
May 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Olga Nilsson

RN, SC

Karolinska University Hospital

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.

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale (HADS)

Time Frame: 12 months

A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.

Secondary Outcomes

  • SF12(12 months)
  • Quality from the patient's perspective (QPP)(12 months)

Study Sites (1)

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