NCT05247801|Completed
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Sponsor study identifier
interventional
142
1 country
1
Study Start
April 11, 2022
Actual (reported)Primary Completion
November 13, 2024
Actual (reported)Study Completion
December 12, 2024
Actual (reported)Experimental study to test the effectiveness of a psychoeducational intervention using virtual reality, aimed at caregivers of multi-pathological and polypharmacy persons to promote safer medication use at home. Experimental design with two groups (experimental and control), pre-post measures, and participants assignment to groups by simple randomization. Null hypothesis. There will be no differences in the frequency of medication errors at home, the severity of the consequences of medication errors, perceived self-efficacy, and health literacy between caregivers using a dosing device (control group) and caregivers using a dosing device with the reinforcement of a psychoeducational intervention designed ad hoc (experimental group).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 21, 2022
Actual (reported)February 21, 2022
Actual (reported)April 11, 2022
Actual (reported)November 13, 2024
Actual (reported)December 12, 2024
Actual (reported)Change from Baseline Frequency of Medication Errors after the intervention (6 months later).
The number of medication errors, type, and consequences (adverse events and consumption of healthcare resources to mitigate the effect of the error). Self-reported measure. Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
Change from Baseline Health Literacy after the intervention (6 months later).
Health Literacy validated questionnaire.
Pre- and post-intervention measurement (6 months time lapse).
Change from Baseline Therapeutic Adherence after the intervention (12 months later).
Therapeutic Adherence validated questionnaire.
Pre- and post-intervention measurement (12 months time lapse).
Change from Baseline Locus of Control after the intervention (12 months later).
Seventy one caregivers of multi-pathological and polypharmacy patients will receive psychoeducational intervention based on virtual reality and a dosing device for safer medication use at home. The intervention will be developed in a previous project phase using a mixed methodology (observational study and qualitative techniques). The intervention will be group-based and consist of motivational discussions and a review of audiovisual materials to promote self-efficacy and health literacy on the safe use of medication at home (most frequent errors, preventive strategies, etc.). Study period: 15 days intervention and follow-up 6 months.
The 71 subjects assigned to the control group will use a medication dosing device and will receive information on how to use it for medication errors. Study period: 15 days intervention and follow-up 6 months.
The intervention is yet to be defined. Psychoeducational intervention based on virtual reality, demonstrations, and psychoeducational content using virtual reality. Contents: Most frequent medication errors at home. Approaches to risk management in the home. Correct use of the most common medications in different patient profiles. Strategies to avoid medication errors. Guidance to alleviate the burden of responsibility suffered by women as a result of the gender bias derived from assuming the caregiver role. Other.
Miguel Hernández University
Elche, Alicante, 03202, Spain
Tinetti ME, Fried TR, Boyd CM. Designing health care for the most common chronic condition--multimorbidity. JAMA. 2012 Jun 20;307(23):2493-4. doi: 10.1001/jama.2012.5265. No abstract available.
Haro JM, Tyrovolas S, Garin N, Diaz-Torne C, Carmona L, Sanchez-Riera L, Perez-Ruiz F, Murray CJ. The burden of disease in Spain: results from the global burden of disease study 2010. BMC Med. 2014 Dec 5;12:236. doi: 10.1186/s12916-014-0236-9.
José Joaquín Mira, Ph.D.
Univ. Miguel Hernández; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la CV
142 participants (actual enrollment reported by the registry).
Locus of Control Test - Abridged.
Pre- and post-intervention measurement (12 months time lapse).
Change from Baseline Self-efficacy after the intervention (12 months later).
Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015).
Pre- and post-intervention measurement (12 months time lapse).
Perceived usefulness of the information provided at the time of intervention completion.
Ad hoc survey
Post-intervention measure (15 days after the start of the intervention).
Perceived usefulness of the information provided after 3 months from the end of the intervention.
Ad hoc survey
Post-intervention measure (after 3 months).
Perceived usefulness of the information provided after 6 months from the end of the intervention.
Ad hoc survey
Post-intervention measure (after 6 months).
Perceived usefulness of the information provided after 12 months from the end of the intervention.
Ad hoc survey
Post-intervention measure (after12 months).
Family Caregivers' Experience at the time of intervention completion.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (15 days after the start of the intervention).
Family Caregivers' Experience after 3 months from the end of the intervention.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (after 3 months).
Family Caregivers' Experience after 6 months from the end of the intervention.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (after 6 months).
Family Caregivers' Experience after 12 months from the end of the intervention.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (after 6 months).
Use of medication dosing device.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Masana L. [Long-term informal care in Spain: challenges, views and solutions]. Salud Colect. 2017 Apr-Jun;13(2):337-352. doi: 10.18294/sc.2017.1237. Spanish.
Heckel L, Fennell KM, Mohebbi M, Byrnes M, Livingston PM. Demographic characteristics, call details and psychosocial support needs of the family/friends of someone diagnosed with cancer who access Australian Cancer Council telephone information and support services. Eur J Oncol Nurs. 2017 Jun;28:86-91. doi: 10.1016/j.ejon.2017.03.007. Epub 2017 Apr 6.
Park M, Choi S, Lee SJ, Kim SH, Kim J, Go Y, Lee DY. The roles of unmet needs and formal support in the caregiving satisfaction and caregiving burden of family caregivers for persons with dementia. Int Psychogeriatr. 2018 Apr;30(4):557-567. doi: 10.1017/S104161021700196X. Epub 2017 Sep 28.
Guilabert M, Amil P, Gonzalez-Mestre A, Gil-Sanchez E, Vila A, Contel JC, Ansotegui JC, Solas O, Bacigalupe MT, Fernandez-Cano P, Arteagoitia M, Mira JJ. The Measure of the Family Caregivers' Experience. Int J Environ Res Public Health. 2018 Sep 18;15(9):2040. doi: 10.3390/ijerph15092040.
Look KA, Stone JA. Medication management activities performed by informal caregivers of older adults. Res Social Adm Pharm. 2018 May;14(5):418-426. doi: 10.1016/j.sapharm.2017.05.005. Epub 2017 May 16.
Panagioti M, Khan K, Keers RN, Abuzour A, Phipps D, Kontopantelis E, Bower P, Campbell S, Haneef R, Avery AJ, Ashcroft DM. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. BMJ. 2019 Jul 17;366:l4185. doi: 10.1136/bmj.l4185.
Mira JJ, Lorenzo S, Guilabert M, Navarro I, Perez-Jover V. A systematic review of patient medication error on self-administering medication at home. Expert Opin Drug Saf. 2015 Jun;14(6):815-38. doi: 10.1517/14740338.2015.1026326. Epub 2015 Mar 16.
Mira JJ, Navarro IM, Guilabert M, Aranaz J. [Frequency of medication errors by patients]. Rev Panam Salud Publica. 2012 Feb;31(2):95-101. doi: 10.1590/s1020-49892012000200001. Spanish.
Mira JJ, Martinez-Jimeno L, Orozco-Beltran D, Iglesias-Alonso F, Lorenzo S, Nuno R, Perez P, Toro N, Perez-Jover V, Gil-Guillen V. What older complex chronic patients need to know about their everyday medication for safe drug use. Expert Opin Drug Saf. 2014 Jun;13(6):713-21. doi: 10.1517/14740338.2014.916272. Epub 2014 May 12.
SCHWARTZ D, WANG M, ZEITZ L, GOSS ME. Medication errors made by elderly, chronically ill patients. Am J Public Health Nations Health. 1962 Dec;52(12):2018-29. doi: 10.2105/ajph.52.12.2018. No abstract available.
Grossman MR, Zak DK, Zelinski EM. Mobile Apps for Caregivers of Older Adults: Quantitative Content Analysis. JMIR Mhealth Uhealth. 2018 Jul 30;6(7):e162. doi: 10.2196/mhealth.9345.
Sala-Gonzalez M, Perez-Jover V, Guilabert M, Mira JJ. Mobile Apps for Helping Informal Caregivers: A Systematic Review. Int J Environ Res Public Health. 2021 Feb 10;18(4):1702. doi: 10.3390/ijerph18041702.
Schwappach DL. Review: engaging patients as vigilant partners in safety: a systematic review. Med Care Res Rev. 2010 Apr;67(2):119-48. doi: 10.1177/1077558709342254. Epub 2009 Aug 11.
Smith F, Francis SA, Gray N, Denham M, Graffy J. A multi-centre survey among informal carers who manage medication for older care recipients: problems experienced and development of services. Health Soc Care Community. 2003 Mar;11(2):138-45. doi: 10.1046/j.1365-2524.2003.00415.x.
Alsaeed D, Jamieson E, Gul MO, Smith FJ. Challenges to optimal medicines use in people living with dementia and their caregivers: A literature review. Int J Pharm. 2016 Oct 30;512(2):396-404. doi: 10.1016/j.ijpharm.2015.12.050. Epub 2015 Dec 22.
Hodgkinson B, Koch S, Nay R, Nichols K. Strategies to reduce medication errors with reference to older adults. Int J Evid Based Healthc. 2006 Mar;4(1):2-41. doi: 10.1111/j.1479-6988.2006.00029.x.
Appel L, Appel E, Bogler O, Wiseman M, Cohen L, Ein N, Abrams HB, Campos JL. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Front Med (Lausanne). 2020 Jan 15;6:329. doi: 10.3389/fmed.2019.00329. eCollection 2019.
Oh-Park M, Doan T, Dohle C, Vermiglio-Kohn V, Abdou A. Technology Utilization in Fall Prevention. Am J Phys Med Rehabil. 2021 Jan 1;100(1):92-99. doi: 10.1097/PHM.0000000000001554.
Brydon M, Kimber J, Sponagle M, MacLaine J, Avery J, Pyke L, Gilbert R. Virtual Reality as a Tool for Eliciting Empathetic Behaviour in Carers: An Integrative Review. J Med Imaging Radiat Sci. 2021 Sep;52(3):466-477. doi: 10.1016/j.jmir.2021.04.005. Epub 2021 May 20.
Mira JJ, Gil-Hernandez E, Sanchez-Garcia A, Ribeiro-Neves V, Matarredona V, Perez-Esteve C, Carrillo I, Arroyo A, Ballester P, Guilabert M. A randomised trial of a psychoeducational intervention to improve home care safety for informal caregivers. Sci Rep. 2026 Jun 8. doi: 10.1038/s41598-026-56850-6. Online ahead of print.
First Submitted
January 21, 2022
First Posted
February 21, 2022
Study Start
April 11, 2022
Actual (reported)Primary Completion
November 13, 2024
Actual (reported)Study Completion
December 12, 2024
Actual (reported)Last Updated
June 26, 2025
Record last verified: 2025-06
The databases, without identification and code registration, will be available at OSF (Center for Open Science) for access by the scientific community. the scientific community.
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