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

NCT ID: NCT03157973

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Aortic Aneurysm

Keywords

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Information Literacy Nursing Care Social Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

The nature of the intervention rules out masking.

Study Groups

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Education intervention

Group Type EXPERIMENTAL

Education intervention

Intervention Type OTHER

eHealth tool and standardized nurse-led follow-up.

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education intervention

eHealth tool and standardized nurse-led follow-up.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olga Nilsson

RN, SC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecka Hultgren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Department of Vascular Surgery, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 39812416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34021309 (View on PubMed)

Other Identifiers

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Dnr 2016/1253-31/4

Identifier Type: -

Identifier Source: org_study_id