Caregivers of Multi-pathological and Polypharmacy AdultsNCT05247801
Safe Use of Medication at Home by Caregivers. Experimental Study
A study testing Psychoeducational intervention for safe medication use at home + Medication dosing device and Medication dosing device in people with Caregivers of Multi-pathological and Polypharmacy Adults, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregivers of Multi-pathological and Polypharmacy Adults
- What is being tested?
- Psychoeducational intervention for safe medication use at home + Medication dosing device and Medication dosing device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Background. Population aging is leading to an increase in the number of multi-pathological and polymedicated patients. These patients are at increased risk of suffering adverse events due to medication errors (ME), especially if Barthel≤55. The management of their medication places an added burden of stress on those who assume responsibility for their care. This task, due to the existing gender gap, falls more often on women.
Objective. To promote the safe use of medication in the home by those who assume the role of caregivers of these patients.
Method. Mixed research study. First: Nominal groups (N=128) and survey (N=1255) to design a psychoeducational intervention aimed at caregivers based on the identification of ME, its causes and consequences, and risk factors that contribute to ME. Second: Single-subject experimental design (two groups, experimental and control, with pre-post measures) to determine the effectiveness of the psycho-educational intervention (n=142).
Setting. Primary care centers and caregivers' associations and training schools in Alicante, Granada, Madrid, Pamplona, Seville, and Zaragoza.
Expected results. Identify critical elements for medication risk management in the home by caregivers. Low-cost psycho-educational intervention for safer use of medication adjusted to the possible different needs of male and female caregivers. The transfer of results will be mainly oriented to reinforce the action carried out by nursing and caregivers' training schools.
- Being tested
- Psychoeducational intervention for safe medication use at home + Medication dosing device, Medication dosing device
- Keywords
- Medication Errors, Patient Safety, Psychoeducational Intervention, Risk Management, Health Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational intervention for safe medication use at home + Medication dosing deviceBehavioural
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.
Medication dosing deviceDevice
Use of medication dosing device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Medication dosing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Pre- and post-intervention measurement (6 months time lapse).
Change from Baseline Therapeutic Adherence after the intervention (12 months later).
Therapeutic Adherence validated questionnaire.
Measured: 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.
Measured: 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).
Measured: Pre- and post-intervention measurement (12 months time lapse).
Perceived usefulness of the information provided at the time of intervention completion.
Ad hoc survey
Measured: 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
Measured: Post-intervention measure (after 3 months).
Perceived usefulness of the information provided after 6 months from the end of the intervention.
Ad hoc survey
Measured: Post-intervention measure (after 6 months).
Perceived usefulness of the information provided after 12 months from the end of the intervention.
Ad hoc survey
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Post-intervention measure (after 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start11 Apr 2022
- Primary completion13 Nov 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Caregivers of Multi-pathological and Polypharmacy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Aragones De Salud, Fondo de Investigación en Salud (FIS), Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Hospital General de Elda, Servicio Navarro de Salud - Osasunbidea, Hospital Universitari Sant Joan d'Alacant, Hospital Universitario San Cecilio, Fundación Pública Andaluza Progreso y Salud
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
- Investigators
- José Joaquín Mira, Ph.D., Principal investigator, Univ. Miguel Hernández; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247801
- Sponsor's protocol ID
- PI21/00646
- Status last verified
- Jun 2025
- First submitted
- 21 Jan 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22797447Haro 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.
PubMed 25480438Masana 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.
PubMed 28832828Heckel 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.
PubMed 28478861Park 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.
PubMed 28956524Guilabert 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.
PubMed 30231535Look 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.
PubMed 28528023Panagioti 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.
PubMed 31315828Mira 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.
PubMed 25774444Mira 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.
PubMed 22522870Mira 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.
PubMed 24821193SCHWARTZ 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.
PubMed 13987359Grossman 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.
PubMed 30061093Sala-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.
PubMed 33578819Schwappach 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.
PubMed 19671916
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Use of Medication at Home by Caregivers. Experimental Study
- ClinicalTrials.gov ID
- NCT05247801
- Acronym / sponsor ID
- PI21/00646
- Keywords
- Medication Errors, Patient Safety, Psychoeducational Intervention, Risk Management, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Servicio Aragones De Salud, Fondo de Investigación en Salud (FIS), Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Hospital General de Elda, Servicio Navarro de Salud - Osasunbidea, Hospital Universitari Sant Joan d'Alacant, Hospital Universitario San Cecilio, Fundación Pública Andaluza Progreso y Salud
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background. Population aging is leading to an increase in the number of multi-pathological and polymedicated patients. These patients are at increased risk of suffering adverse events due to medication errors (ME), especially if Barthel≤55. The management of their medication places an added burden of stress on those who assume responsibility for their care. This task, due to the existing gender gap, falls more often on women.
Objective. To promote the safe use of medication in the home by those who assume the role of caregivers of these patients.
Method. Mixed research study. First: Nominal groups (N=128) and survey (N=1255) to design a psychoeducational intervention aimed at caregivers based on the identification of ME, its causes and consequences, and risk factors that contribute to ME. Second: Single-subject experimental design (two groups, experimental and control, with pre-post measures) to determine the effectiveness of the psycho-educational intervention (n=142).
Setting. Primary care centers and caregivers' associations and training schools in Alicante, Granada, Madrid, Pamplona, Seville, and Zaragoza.
Expected results. Identify critical elements for medication risk management in the home by caregivers. Low-cost psycho-educational intervention for safer use of medication adjusted to the possible different needs of male and female caregivers. The transfer of results will be mainly oriented to reinforce the action carried out by nursing and caregivers' training schools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Psychoeducational Intervention) | Experimental | Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing deviceSeventy 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. |
| Control Group (Dosing Device) | Active comparator | Device: Medication dosing deviceThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational intervention for safe medication use at home + Medication dosing deviceThe 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. | Behavioural | Experimental Group (Psychoeducational Intervention) |
| Medication dosing deviceUse of medication dosing device. | Device | Control Group (Dosing Device) |
Primary outcome
Change from Baseline Frequency of Medication Errors after the intervention (6 months later).
Time frame: Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
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).
Change from Baseline Health Literacy after the intervention (6 months later).
Time frame: Pre- and post-intervention measurement (6 months time lapse).
Health Literacy validated questionnaire.
Change from Baseline Therapeutic Adherence after the intervention (12 months later).
Time frame: Pre- and post-intervention measurement (12 months time lapse).
Therapeutic Adherence validated questionnaire.
Change from Baseline Locus of Control after the intervention (12 months later).
Time frame: Pre- and post-intervention measurement (12 months time lapse).
Locus of Control Test - Abridged.
Change from Baseline Self-efficacy after the intervention (12 months later).
Time frame: Pre- and post-intervention measurement (12 months time lapse).
Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015).
Perceived usefulness of the information provided at the time of intervention completion.
Time frame: Post-intervention measure (15 days after the start of the intervention).
Ad hoc survey
Perceived usefulness of the information provided after 3 months from the end of the intervention.
Time frame: Post-intervention measure (after 3 months).
Ad hoc survey
Perceived usefulness of the information provided after 6 months from the end of the intervention.
Time frame: Post-intervention measure (after 6 months).
Ad hoc survey
Perceived usefulness of the information provided after 12 months from the end of the intervention.
Time frame: Post-intervention measure (after12 months).
Ad hoc survey
Family Caregivers' Experience at the time of intervention completion.
Time frame: Post-intervention measure (15 days after the start of the intervention).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Family Caregivers' Experience after 3 months from the end of the intervention.
Time frame: Post-intervention measure (after 3 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Family Caregivers' Experience after 6 months from the end of the intervention.
Time frame: Post-intervention measure (after 6 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Family Caregivers' Experience after 12 months from the end of the intervention.
Time frame: Post-intervention measure (after 6 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 22797447Tinetti 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.
- Background: PubMed 25480438Haro 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.
- Background: PubMed 28832828Masana 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.
- Background: PubMed 28478861Heckel 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.
- Background: PubMed 28956524Park 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.
- Background: PubMed 30231535Guilabert 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.
- Background: PubMed 28528023Look 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.
- Background: PubMed 31315828Panagioti 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.
- Background: PubMed 25774444Mira 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.
- Background: PubMed 22522870Mira 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.
- Background: PubMed 24821193Mira 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.
- Background: PubMed 13987359SCHWARTZ 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Joaquín Mira, Ph.D. principal investigator
Univ. Miguel Hernández; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la CV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention for safe medication use at home + Medication dosing device and Medication dosing device in people with Caregivers of Multi-pathological and Polypharmacy Adults, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Frequency of Medication Errors after the intervention (6 months later). (time frame: Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247801, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.