Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedDecember 22, 2022
December 1, 2022
5.5 years
May 16, 2017
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
SF12
12 months
Quality from the patient's perspective (QPP)
12 months
Study Arms (2)
Education intervention
EXPERIMENTALStandard of Care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Ability to speak and understand Swedish
- Planned for elective surgical repair of an abdominal aortic aneurysm
You may not qualify if:
- Severe visual impairment or blindness
- Severe hearing impairment or deafness
- Diagnosed dementia
- Medical condition with a suspected life expectancy of \< 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Karolinska Institutetcollaborator
Study Sites (1)
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, 17176, Sweden
Related Publications (2)
Nilsson O, Stenman M, Letterstal A, Hultgren R. One-year results of an eHealth intervention on anxiety in patients undergoing abdominal aortic aneurysm surgery: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae144. doi: 10.1093/bjsopen/zrae144.
PMID: 39812416DERIVEDNilsson 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.
PMID: 34021309DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecka Hultgren, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The nature of the intervention rules out masking.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, SC
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 17, 2017
Study Start
December 1, 2016
Primary Completion
May 30, 2022
Study Completion
May 30, 2022
Last Updated
December 22, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share