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

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03157973
• Collaborator: Karolinska Institutet (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm	Other: Education intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: The nature of the intervention rules out masking.
• Primary Purpose: Supportive Care
• Official Title: Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education intervention	Other: Education intervention; eHealth tool and standardized nurse-led follow-up.
No Intervention: Standard of Care

Outcome Measures

Primary Outcome Measures

1. 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

1. SF12 [12 months]

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

2. Quality from the patient's perspective (QPP) [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Vascular Surgery, Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

• Karolinska University Hospital
• Karolinska Institutet

Investigators

• Principal Investigator: Rebecka Hultgren, MD, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olga Nilsson, RN, SC, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT03157973
• Other Study ID Numbers: Dnr 2016/1253-31/4
• First Posted: May 17, 2017
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Olga Nilsson, RN, SC, Karolinska University Hospital: Information Literacy; Nursing Care; Social Support
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of Sep 2, 2020