Aortic AneurysmNCT03157973
Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
A study testing Education intervention in people with Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Education intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2016to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to speak and understand Swedish
- Planned for elective surgical repair of an abdominal aortic aneurysm
Who cannot join
- Severe visual impairment or blindness
- Severe hearing impairment or deafness
- Diagnosed dementia
- Medical condition with a suspected life expectancy of < 1 year.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, 17176
About this study
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.
Read the 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.
- Conditions
- Aortic Aneurysm
- Being tested
- Education intervention
- Keywords
- Information Literacy, Nursing Care, Social Support
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education interventionOther
eHealth tool and standardized nurse-led follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Education intervention | Experimental | Not described Receives: Other: Education intervention |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
A validated self-assessment scale that measures symptoms of anxiety and depression in a non-psychiatric population.
Measured: 12 months
Secondary outcomes (2)
SF12
A 12-item questionnaire that measures 8 dimensions of physical and mental health.
Measured: 12 months
Quality from the patient's perspective (QPP)
A validated self-assessment scale measuring patient perceived quality of care.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startDec 2016
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Olga Nilsson, Karolinska University Hospital
- Investigators
- Rebecka Hultgren, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157973
- Sponsor's protocol ID
- Dnr 2016/1253-31/4
- Status last verified
- Dec 2022
- First submitted
- 16 May 2017
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39812416Nilsson 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.
PubMed 34021309
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT03157973
- Acronym / sponsor ID
- Dnr 2016/1253-31/4
- Conditions
- Aortic Aneurysm
- Keywords
- Information Literacy, Nursing Care, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education intervention | Experimental | Other: Education intervention |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to speak and understand Swedish
- Planned for elective surgical repair of an abdominal aortic aneurysm
Key exclusion criteria (4 listed)
- Severe visual impairment or blindness
- Severe hearing impairment or deafness
- Diagnosed dementia
- Medical condition with a suspected life expectancy of < 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education interventioneHealth tool and standardized nurse-led follow-up. | Other | Education intervention |
Primary outcome
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.
2 secondary outcomes
SF12
Time frame: 12 months
Quality from the patient's perspective (QPP)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 39812416Nilsson 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.
- Derived from this study: PubMed 34021309Nilsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecka Hultgren, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education intervention in people with Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.