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

Primary Purpose

Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Education intervention
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aortic Aneurysm focused on measuring Information Literacy, Nursing Care, Social Support

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Vascular Surgery, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education intervention

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.

Secondary Outcome Measures

SF12
A 12-item questionnaire that measures 8 dimensions of physical and mental health.
Quality from the patient's perspective (QPP)
A validated self-assessment scale measuring patient perceived quality of care.

Full Information

First Posted
May 16, 2017
Last Updated
December 21, 2022
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03157973
Brief Title
Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
Official Title
Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
Keywords
Information Literacy, Nursing Care, Social Support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The nature of the intervention rules out masking.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education intervention
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Education intervention
Intervention Description
eHealth tool and standardized nurse-led follow-up.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
SF12
Description
A 12-item questionnaire that measures 8 dimensions of physical and mental health.
Time Frame
12 months
Title
Quality from the patient's perspective (QPP)
Description
A validated self-assessment scale measuring patient perceived quality of care.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecka Hultgren, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular Surgery, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34021309
Citation
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.
Results Reference
derived

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

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