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OpenTrials
Completed

NCT Number: NCT03157973

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular Surgery, Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education Intervention

Other

eHealth tool and standardized nurse-led follow-up.

Primary outcomes

  1. 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

  1. SF12

    Time frame: 12 months

    A 12-item questionnaire that measures 8 dimensions of physical and mental health.

  2. Quality from the patient's perspective (QPP)

    Time frame: 12 months

    A validated self-assessment scale measuring patient perceived quality of care.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 17, 2017
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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