@misc{10481/112489,
year = {2026},
month = {3},
url = {https://hdl.handle.net/10481/112489},
abstract = {Objective:
To assess the feasibility of randomising a sufficiently large number of pregnant women who screen positive for intimate partner violence (IPV) to perform a full-scale effectiveness trial.
Methods:
This pilot randomised trial was nested within a cohort of IPV-positive pregnant women who accepted an e-health package in Spain and Denmark. This study was co-designed with patient input using a modified Zelen’s design and a qualitative evaluation. Eligible women were randomised to an intervention (received the e-health package) or to a control (received it with a delay). The primary outcome was the proportion of women screened positive for IPV who consented to be randomised to receive an e-health package with a delay.
Results:
Twenty-nine of the 51 women in the cohort were randomised. Of these, 12 were allocated to the control group, and 7 (58.3%) consented to receive the e-health package with a delay, i.e., 24.1% of the total randomised and 13.7% of the total cohort. The proportion of randomized women who adhered to treatment was 31.03% (9/29). Complete outcome data were obtained in 7/17 (41.17%) and 2/12 (16.66%) women in the intervention and control groups, respectively. Qualitative interviews indicated that the women perceived the intervention as beneficial and that delaying it was not acceptable.
Conclusions:
This pilot randomised trial indicated that a future full-scale randomised study would likely be unfeasible based on our a priori criteria to stop the trial. If a future large trial is launched, it should include an internal pilot with strict go/no-go criteria monitored by an independent committee.},
organization = {European Commission’s Rights, Equality and Citizenship program - (REC-RDAP-GBV-AG-2019 grant agreement 881648)},
organization = {Regional Government of Andalusia, Spain - (PPRO-CTS1073-G-2023)},
organization = {Regional Ministry of University, Research, and Innovation and the University of Granada - (DGP_EMEC_2023_00458)},
publisher = {Elsevier},
keywords = {intimate partner violence},
keywords = {e-Health},
keywords = {telemedicine},
title = {E-health intervention in pregnant women exposed to intimate partner violence (eIPV): Results of a pilot randomised controlled trial},
doi = {10.1016/j.conctc.2026.101634},
author = {Zapata Calvente, Antonella Ludmila and Bueno Cavanillas, Aurora and Andreasen, Karen and Søndergaard Linde, Ditte and Rasch, Vibeke and Saeed Khan, Khalid and Martín De Las Heras, Stella},
}