Evidence map›Paper›PMID 38191813›Full record

Trial reportSurgical endoscopy2024

Better stoma care using the Stoma App: does it help? A first randomized double-blind clinical trial on the effect of mobile healthcare on quality of life in stoma patients.

Sebastiaan L van der Storm, Esther C J Consten, Marc J P M Govaert, Jurriaan B Tuynman, Steven J Oosterling, Brechtje A Grotenhuis, Anke B Smits, Hendrik A Marsman, Charles C van Rossem, Eino B van Duyn and 7 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Surgical endoscopy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Observational
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Sebastiaan L van der StormSurgery, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. s.vanderstorm@amsterdamumc.nl.ORCID 0000-0001-5170-3521
Esther C J ConstenSurgery, Meander Medical Center, Amersfoort, The Netherlands.
Marc J P M GovaertSurgery, Dijklander Ziekenhuis, Hoorn, The Netherlands.
Jurriaan B TuynmanSurgery, Amsterdam UMC - Location VUmc, Amsterdam, The Netherlands.
Steven J OosterlingSurgery, Spaarne Gasthuis, Hoofddorp, The Netherlands.
Brechtje A GrotenhuisSurgery, Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, The Netherlands.
Anke B SmitsSurgery, Antonius Ziekenhuis, Nieuwengein, The Netherlands.
Hendrik A MarsmanSurgery, OLVG Hospital, Amsterdam, The Netherlands.
Charles C van RossemSurgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands.
Eino B van DuynSurgery, Medisch Spectrum Twente, Enschede, The Netherlands.
Lindsey C F de NesSurgery, Maasziekenhuis Pantein, Boxmeer, The Netherlands.
Emiel VerdaasdonkSurgery, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.
Tammo S de Vries ReilinghSurgery, Elkerliek Ziekenhuis, Helmond, The Netherlands.
Wouter VeningSurgery, Rijnstate Ziekenhuis, Arnhem, The Netherlands.
Willem A BemelmanSurgery, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
Marlies P SchijvenSurgery, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. m.p.schijven@amsterdamumc.nl.ORCID 0000-0001-7013-0116
Stoma APPtimize collaborative study group

Funding

Maag Lever Darm Stichting ZP 19-09SIDN funds 191124
6 · The paper itself

Abstract

backgroundReceiving a stoma significantly impacts patients' quality of life. Coping with this new situation can be difficult, which may result in a variety of physical and psychosocial problems. It is essential to provide adequate guidance to help patients cope with their stoma, as this positively influences self-efficacy in return. Higher self-efficacy reduces psychosocial problems increasing patient's quality of life. This study investigates whether a new mobile application, the Stoma App, improves quality of life. And if personalized guidance, timed support, and peer contact offered as an in-app surplus makes a difference.

methodsA double-blind, randomized controlled trial was conducted between March 2021 and April 2023. Patients aged > 18 years undergoing ileostomy or colostomy surgery, in possession of a compatible smartphone were included. The intervention group received the full version of the app containing personalized and time guidance, peer support, and generic (non-personalized) stoma-related information. The control group received a restricted version with only generic information. Primary outcome was stoma quality of life. Secondary outcomes included psychological adaption, complications, re-admittance, reoperations, and length of hospital stay.

resultsThe intervention version of the app was used by 96 patients and the control version by 112 patients. After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month postoperatively (p = 0.038). On secondary outcomes, no significant improvements could be retrieved of the intervention group.

conclusionThe Stoma App improves the quality of life of stoma patients. Peer support and personalized guidance are of significant importance in building self-efficacy. It is to be recommended to implement Stoma app-freely available software qualifying as a medical device-in standard stoma care pathways for the benefits of both patients and healthcare providers.

Indexed as

Mobile ApplicationsSurgical StomasAdultColostomyHumansIleostomyQuality of LifeColorectal surgeryEhealthMhealthMobile applicationQuality of lifeStoma

Identifiers

PMID38191813
PMCPMC10881728

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.