A pilot study of a digital ostomy leakage notification system: Impact on worry and quality of life

R.R.W. Brady; J. Fellows; Sø Meisner; J.K. Olsen; M. Vestergaard; T.A. Ajslev

doi:10.12968/bjon.2023.32.6.S4

A pilot study of a digital ostomy leakage notification system: Impact on worry and quality of life

R.R.W. Brady
, J. Fellows
, Sø Meisner
, J.K. Olsen
, M. Vestergaard
, T.A. Ajslev

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

11 Downloads (Pure)

Abstract

Background:
More than 90% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity.

Aims:
To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage.

Method:
A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL).

Findings:
Mean age was 56 years, 60% had an ileostomy, and 40% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (P<0.001), worry about leakage decreased significantly (P<0.001) and QoL improved.

Conclusion:
The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage.

Original language	English
Pages (from-to)	S4 - S12
Journal	British Journal of Nursing (BJN)
Volume	32
Issue number	6
Early online date	23 Mar 2023
DOIs	https://doi.org/10.12968/bjon.2023.32.6.S4
Publication status	Published (in print/issue) - 23 Mar 2023

Bibliographical note

The authors would like to thank the clinical team and Margit's Nursing involved in study execution and data collection, and Helle Doré Hansen for doing the statistical analysis. Furthermore, the authors want to express their gratitude to the people living with an ostomy who participated in the study

Keywords

Ostomy
Leakage
Quality of life
Stoma leakage detection
Digital device
Patient-facing apps

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Cite this

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title = "A pilot study of a digital ostomy leakage notification system: Impact on worry and quality of life",

abstract = "Background: More than 90\% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity. Aims: To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage. Method: A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL). Findings: Mean age was 56 years, 60\% had an ileostomy, and 40\% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (P<0.001), worry about leakage decreased significantly (P<0.001) and QoL improved. Conclusion: The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage.",

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note = "The authors would like to thank the clinical team and Margit's Nursing involved in study execution and data collection, and Helle Dor{\'e} Hansen for doing the statistical analysis. Furthermore, the authors want to express their gratitude to the people living with an ostomy who participated in the study",

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AU - Olsen, J.K.

AU - Vestergaard, M.

AU - Ajslev, T.A.

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N2 - Background: More than 90% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity. Aims: To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage. Method: A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL). Findings: Mean age was 56 years, 60% had an ileostomy, and 40% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (P<0.001), worry about leakage decreased significantly (P<0.001) and QoL improved. Conclusion: The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage.

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A pilot study of a digital ostomy leakage notification system: Impact on worry and quality of life

Abstract

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Keywords

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