A supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial.
Endometriosis
Feasibility
Intervention
Randomised controlled trial
Text message
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
19
09
2022
revised:
24
01
2023
accepted:
13
02
2023
entrez:
10
3
2023
pubmed:
11
3
2023
medline:
11
3
2023
Statut:
epublish
Résumé
As a high symptom burden chronic condition, endometriosis is associated with diminished quality of life (QoL) and psychological distress. The EndoSMS text message intervention was developed to inform and support individuals living with endometriosis. The primary aim of this study is to assess the acceptability, feasibility and preliminary efficacy of EndoSMS, to improve endometriosis-specific QoL and reduce psychological distress in a randomised controlled trial, compared with care as usual. We will additionally assess the impact of EndoSMS on self-efficacy for managing endometriosis. A two-arm parallel pilot randomised controlled trial with waitlist control was conducted. Baseline assessments included QoL, psychological distress, self-efficacy, demographic and medical variables. Following baseline survey completion, participants were randomised to either the Intervention (EndoSMS: 3-months of text messaging) or Control condition. At 3-month follow-up, all participants completed an online survey reassessing outcomes, and Intervention participants provided quantitative and qualitative user feedback on EndoSMS. Data collection commenced on 18 November 2021 and was completed on 30 March 2022. Descriptive statistics will be used to analyse feasibility and acceptability of the intervention. Preliminary efficacy analyses will be conducted using linear mixed models for QoL, psychological distress and self-efficacy outcomes. Subgroup analyses will also be conducted for typically underserved populations (e.g., rural/regional). This pilot will provide acceptability, feasibility and preliminary efficacy evidence for the impact of a supportive text messaging program for endometriosis. It will contribute to understanding how to optimally support individuals in living with and managing their endometriosis. Australian New Zealand Clinical Trials Registry.
Identifiants
pubmed: 36895681
doi: 10.1016/j.conctc.2023.101093
pii: S2451-8654(23)00039-X
pmc: PMC9989515
doi:
Types de publication
Journal Article
Langues
eng
Pagination
101093Informations de copyright
© 2023 Published by Elsevier Inc.
Déclaration de conflit d'intérêts
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Funding for this project was granted by Endometriosis Australia. JR is funded by a NHMRC Investigator Grant Leadership Level 2 [GNT2007946]. AS receives a PhD stipend provided by the University of Sydney, Australian Government Research Training Program Scholarship and a Supplementary Postgraduate Research Scholarship in Breast Cancer.
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