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Randomized Controlled Trial
. 2021 Aug 19;108(8):917-924.
doi: 10.1093/bjs/znab151.

A randomized clinical trial of an eHealth intervention on anxiety in patients undergoing abdominal aortic aneurysm surgery

O Nilsson  1   2 , M Stenman  1   3 , A Letterstål  4   5 , R Hultgren  1   2
Affiliations
Randomized Controlled Trial

A randomized clinical trial of an eHealth intervention on anxiety in patients undergoing abdominal aortic aneurysm surgery

O Nilsson et al. Br J Surg. .

Abstract

Background: The potential benefit of eHealth interventions in patients with abdominal aortic aneurysm (AAA) is uncertain. The primary aim of this study was to investigate the effect of an eHealth intervention on anxiety in patients with AAA undergoing surgery.

Methods: A single-centre randomized clinical trial of patients with AAA scheduled for surgical repair was undertaken. The intervention group received an eHealth tool and psychosocial support besides standard care. The control group received standard care. The analysis of treatment effects was performed as intention-to-treat and per protocol analysis. The primary outcome measure was anxiety mean score (Hospital Anxiety and Depression Scale Anxiety (HADS)-A). Secondary outcomes measures were HADS Depression and short-form 12-item health survey mean scores.

Results: Some 120 participants were randomized. No effect on anxiety mean scores was found in the intention-to-treat analysis (-1.21 versus -0.54, P = 0.330). Among those randomized to the intervention, only 30 of 60 participants used the eHealth tool (application (app) users). The app users were younger and had a higher educational level. A decrease in anxiety mean scores was noted in those who used the app in the per protocol analysis (-2.00 versus -0.54, P = 0.028). The intervention group stated a lower physical-component health-related quality of life (HRQoL) (-4.32 versus -1.16, P = 0.042) but mental-component HRQoL and depressive symptoms were unchanged.

Conclusions: Delivery of an eHealth intervention in this RCT did not result in an improvement in anxiety scores in patients awaiting AAA surgery. Uptake of the eHealth tool was low, although it resulted in lower anxiety scores in those participants who actually used it.

Clinical trial registration number: NCT03157973 (http://www.clinicaltrials.gov).

Plain language summary

The use of digital health technology to deliver information and provide psychosocial support has shown promising results but has been largely unexplored in people undergoing major blood vessel (vascular) surgery. This study reports the results of a randomized, controlled trial to examine the effects of an eHealth intervention on anxiety symptoms in patients undergoing surgical treatment of abdominal aortic aneurysm (a major swelling of the main blood vessel in the tummy). The findings show that an eHealth tool paired with psychosocial support did not reduce anxiety symptoms, measured by Hospital Anxiety and Depression Scale-A. Unfortunately, a large proportion of the participants declined to use the eHealth tool. However, those who used the eHealth tool appeared to benefit from reduced anxiety levels. The findings of the study support further research to understand how to improve engagement of patients with eHealth interventions in surgery. Special attention should be given to improve engagement in people who are elderly and those with lower educational attainment.

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Figures

Fig. 1
Fig. 1
CONSORT diagram Flow diagram describing the design of the study: enrolment, intervention, follow-up and data analysis.
Fig. 2
Fig. 2
Per protocol analyses of mean differences in Hospital Anxiety and Depression Scale Anxiety scores from baseline to follow-up The reference line indicates the minimal clinically important difference. a Changes in Hospital Anxiety and Depression Scale Anxiety (HADS-A) mean scores for control group versus users of the eHealth tool. b Changes in HADS-A mean scores for users versus non-users of the eHealth tool in the intervention group.
See this image and copyright information in PMC

References

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