Safe Use of Medication at Home by Caregivers. Experimental Study

NCT05247801 | Completed

• 1 other identifier: PI21/00646
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Caregivers of Multi-pathological and Polypharmacy Adults

Keywords

Medication Errors; Patient Safety; Psychoeducational Intervention; Risk Management; Health Literacy

Outcome Measures

Primary Outcomes (13)

• 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).

  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).

Study Arms (2)

Experimental Group (Psychoeducational Intervention)

EXPERIMENTAL

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.

Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing device

Control Group (Dosing Device)

ACTIVE COMPARATOR

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.

Device: Medication dosing device

Interventions

Psychoeducational intervention for safe medication use at home + Medication dosing device BEHAVIORAL

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.

Experimental Group (Psychoeducational Intervention)

Medication dosing device DEVICE

Use of medication dosing device.

Control Group (Dosing Device)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or less than 55).
• Residence in Alicante, Granada, Madrid, Pamplona, Seville, or Zaragoza (in the patient's home or the family member's home).
• At patient's charge for at least six months during the year.

You may not qualify if:

• Caregivers of patients who are institutionalized a minimum of 3 months per year.
• Caregivers with experience of more than six months in the use of medication dosing devices.
• Health education/profession.
• Filing of a property claim in the last 5 years.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Servicio Aragonés de Salud (SALUD): collaborator
• Fondo de Investigación en Salud (FIS): collaborator
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana: collaborator
• Hospital General de Elda: collaborator
• Servicio Navarro de Salud - Osasunbidea: collaborator
• Hospital Universitari Sant Joan d'Alacant: collaborator
• Hospital Universitario San Cecilio: collaborator
• Fundación Pública Andaluza Progreso y Salud: collaborator

Study Sites (1)

Miguel Hernández University

Elche, Alicante, 03202, Spain

Location

Related Publications (21)

• 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.

  PMID: 22797447 BACKGROUND

• 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.

  PMID: 25480438 BACKGROUND

• 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.

  PMID: 28832828 BACKGROUND

• 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.

  PMID: 28478861 BACKGROUND

• 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.

  PMID: 28956524 BACKGROUND

• 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.

  PMID: 30231535 BACKGROUND

• 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.

  PMID: 28528023 BACKGROUND

• 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.

  PMID: 31315828 BACKGROUND

• 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.

  PMID: 25774444 BACKGROUND

• 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.

  PMID: 22522870 BACKGROUND

• 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.

  PMID: 24821193 BACKGROUND

• 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.

  PMID: 13987359 BACKGROUND

• 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.

  PMID: 30061093 BACKGROUND

• 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.

  PMID: 33578819 BACKGROUND

• 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.

  PMID: 19671916 BACKGROUND

• 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.

  PMID: 14629216 BACKGROUND

• 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.

  PMID: 26721728 BACKGROUND

• 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.

  PMID: 21631752 BACKGROUND

• 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.

  PMID: 32010701 BACKGROUND

• 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.

  PMID: 32740053 BACKGROUND

• 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.

  PMID: 34023219 BACKGROUND

Study Officials

• José Joaquín Mira, Ph.D.

  Univ. Miguel Hernández; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la CV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants. Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or lower than 55). Recruitment will be carried out by simple randomization based on the diaries of patients seen in the last 18 months in the collaborating centers. Intervention. Psychoeducational intervention based on virtual reality aimed at increasing self-efficacy and health literacy in medication use. Procedure. By simple randomization, participants will be assigned to one of the two groups (control or experimental) after giving their informed consent. They will not know to which group they belong. Treatments. The subjects in the control group will use a dosing device and will receive information on how to use it to avoid medication errors. The experimental group will receive the psychoeducational intervention and the same medication device. The experimental group will receive the psychoeducational intervention. Intervention period: 15 days. Follow-up: 6 months.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 21, 2022
• Study Start: April 11, 2022
• Primary Completion: November 13, 2024
• Study Completion: December 12, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Six months after the data collecting.
• Access Criteria: Data repository is available for the scientific community.

Locations

ES (1)