Drug-Related ProblemsNCT04841863
Secondary Prevention of Dug-related Problems Through Digital Health
A study testing MyPlan digital health platform and Satndard care in people with Drug-Related Problems, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Related Problems
- What is being tested?
- MyPlan digital health platform and Satndard care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2021to Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years.
- Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N.
- Be independent for activities of daily living (equivalent to Barthel 100).
- Have a Chalson Comorbidity Index 2 <= 3.
- Not present cognitive impairment.
- Be directly responsible for pharmacotherapy.
- Have a mobile device compatible with the MyPlan mobile application and access to Wi-Fi or mobile data, enabling the use of the technology platform from home.
Who cannot join
- Important language barrier.
- Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.
- Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria.
- Patients not residing in the territory who cannot be followed-up later.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de la Santa Creu i Sant Pau
Barcelona
Ana Juanes, Doctor, ajuanes@santpau.cat
Jesús Ruiz, Doctor, jruiz@santpau.cat
About this study
Official title: Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.
Read the detailed description
After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized.
The project is structured in two consecutive phases.
- st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study.
- nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.
- Conditions
- Drug-Related Problems
- Being tested
- MyPlan digital health platform, Satndard care
- Keywords
- DRP, Digital Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPlan digital health platformDevice
Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
Satndard careOther
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Drug Code Active Patient o DCAP | Active comparator | Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. Receives: Device: MyPlan digital health platform |
| Standard care | Placebo comparator | Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. Receives: Other: Satndard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
Measured: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
Measured: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Secondary outcomes (11)
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)
Measured: Baseline
Identify risk factors for ED visits related to DRP
Age, sex, social and familiar environment, blood presure (mmHg), heart frequency (bpm), Hb1Ac (%), pain (visual analog scale), weight (kg) and height (cm), chronic kidney disease, number of drugs at admission and at discharge, number of chronic health problems.
Measured: Baseline
Identify which groups of drugs are more frequently associated to DRP
Using ATC group classification
Measured: Baseline
Change in the patient therapeutic adherence
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
Measured: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in the patient therapeutic adherence
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
Measured: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Mesure therapeutic complexity
Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
Measured: Baseline
Identify predictive factors of a greater capacity for digital empowerment.
Using the CAMBADOS questionnaire
Measured: Baseline
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Using the TrilemaSalud questionnaire
Measured: 90-day after discharge (in phase I, Pilot Trial)
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Using the TrilemaSalud questionnaire
Measured: 12-month after discharge (in phase II, Clinical Trial)
Change in the quality of life of patients in the active group
Using the EQ-5D-3L51 questionnaire
Measured: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in the quality of life of patients in the active group
Using the EQ-5D-3L51 questionnaire
Measured: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Drug-Related ProblemsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Laia López Vinardell, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841863
- Sponsor's protocol ID
- IIBSP-COD-2019-46
- Status last verified
- Apr 2021
- First submitted
- 18 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Monitor clinical trial will have access to all study data
Publications
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.
PubMed 9555760Patel P, Zed PJ. Drug-related visits to the emergency department: how big is the problem? Pharmacotherapy. 2002 Jul;22(7):915-23. doi: 10.1592/phco.22.11.915.33630.
PubMed 12126224Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3.
PubMed 24091839Castro I, Guardiola JM, Tuneu L, Sala ML, Faus MJ, Mangues MA. Drug-related visits to the emergency department in a Spanish university hospital. Int J Clin Pharm. 2013 Oct;35(5):727-35. doi: 10.1007/s11096-013-9795-7. Epub 2013 May 22.
PubMed 23695594Banerjee J, Conroy S, Cooke MW. Quality care for older people with urgent and emergency care needs in UK emergency departments. Emerg Med J. 2013 Sep;30(9):699-700. doi: 10.1136/emermed-2012-202080. Epub 2012 Dec 18. No abstract available.
PubMed 23250895Hamilton HJ, Gallagher PF, O'Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatr. 2009 Jan 28;9:5. doi: 10.1186/1471-2318-9-5.
PubMed 19175914Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.
PubMed 18809816Gheewala PA, Peterson GM, Curtain CM, Nishtala PS, Hannan PJ, Castelino RL. Impact of the pharmacist medication review services on drug-related problems and potentially inappropriate prescribing of renally cleared medications in residents of aged care facilities. Drugs Aging. 2014 Nov;31(11):825-35. doi: 10.1007/s40266-014-0208-y.
PubMed 25187228Patterson SM, Cadogan CA, Kerse N, Cardwell CR, Bradley MC, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2014 Oct 7;(10):CD008165. doi: 10.1002/14651858.CD008165.pub3.
PubMed 25288041Campins L, Serra-Prat M, Palomera E, Bolibar I, Martinez MA, Gallo P. Reduction of pharmaceutical expenditure by a drug appropriateness intervention in polymedicated elderly subjects in Catalonia (Spain). Gac Sanit. 2019 Mar-Apr;33(2):106-111. doi: 10.1016/j.gaceta.2017.09.002. Epub 2017 Nov 20.
PubMed 29162290Perez Menendez-Conde C, Bermejo Vicedo T, Delgado Silveira E, Carretero Accame E. Adverse drug reactions which provoke hospital admission. Farm Hosp. 2011 Sep-Oct;35(5):236-43. doi: 10.1016/j.farma.2010.08.003. Epub 2011 May 12. English, Spanish.
PubMed 21570331Donaldson LJ, Kelley ET, Dhingra-Kumar N, Kieny MP, Sheikh A. Medication Without Harm: WHO's Third Global Patient Safety Challenge. Lancet. 2017 Apr 29;389(10080):1680-1681. doi: 10.1016/S0140-6736(17)31047-4. No abstract available.
PubMed 28463129Lancaster K, Abuzour A, Khaira M, Mathers A, Chan A, Bui V, Lok A, Thabane L, Dolovich L. The Use and Effects of Electronic Health Tools for Patient Self-Monitoring and Reporting of Outcomes Following Medication Use: Systematic Review. J Med Internet Res. 2018 Dec 18;20(12):e294. doi: 10.2196/jmir.9284.
PubMed 30563822Martinez-Pillado M, Said-Criado I, Regueiro-Martinez A, Rodriguez IC. E-young chronics y e-senior chronics como nuevos modelos para la atencion a la cronicidad. J Healthc Qual Res. 2018 May-Jun;33(3):119-120. doi: 10.1016/j.jhqr.2018.07.001. No abstract available. Spanish.
PubMed 30328812Park LG, Howie-Esquivel J, Dracup K. A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence. J Adv Nurs. 2014 Sep;70(9):1932-1953. doi: 10.1111/jan.12400. Epub 2014 Apr 1.
PubMed 24689978
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
- ClinicalTrials.gov ID
- NCT04841863
- Acronym / sponsor ID
- IIBSP-COD-2019-46
- Conditions
- Drug-Related Problems
- Keywords
- DRP, Digital Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Apr 2021 (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.
The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.
Detailed description
After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized.
The project is structured in two consecutive phases.
- st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study.
- nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Code Active Patient o DCAP | Active comparator | Device: MyPlan digital health platformInclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. |
| Standard care | Placebo comparator | Other: Satndard careInclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 18 years.
- Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N.
- Be independent for activities of daily living (equivalent to Barthel 100).
- Have a Chalson Comorbidity Index 2 <= 3.
- Not present cognitive impairment.
Key exclusion criteria (4 listed)
- Important language barrier.
- Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.
- Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria.
- Patients not residing in the territory who cannot be followed-up later.
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 |
|---|---|---|
| MyPlan digital health platformInclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions. | Device | Drug Code Active Patient o DCAP |
| Satndard careInclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care. | Other | Standard care |
Primary outcome
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Time frame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Time frame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
11 secondary outcomes
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Time frame: Baseline
Identify risk factors for ED visits related to DRP
Time frame: Baseline
Identify which groups of drugs are more frequently associated to DRP
Time frame: Baseline
Change in the patient therapeutic adherence
Time frame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in the patient therapeutic adherence
Time frame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Mesure therapeutic complexity
Time frame: Baseline
Identify predictive factors of a greater capacity for digital empowerment.
Time frame: Baseline
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Time frame: 90-day after discharge (in phase I, Pilot Trial)
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Time frame: 12-month after discharge (in phase II, Clinical Trial)
Change in the quality of life of patients in the active group
Time frame: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in the quality of life of patients in the active group
Time frame: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 9555760Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.
- Background: PubMed 12126224Patel P, Zed PJ. Drug-related visits to the emergency department: how big is the problem? Pharmacotherapy. 2002 Jul;22(7):915-23. doi: 10.1592/phco.22.11.915.33630.
- Background: PubMed 24091839Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3.
- Background: PubMed 23695594Castro I, Guardiola JM, Tuneu L, Sala ML, Faus MJ, Mangues MA. Drug-related visits to the emergency department in a Spanish university hospital. Int J Clin Pharm. 2013 Oct;35(5):727-35. doi: 10.1007/s11096-013-9795-7. Epub 2013 May 22.
- Background: PubMed 23250895Banerjee J, Conroy S, Cooke MW. Quality care for older people with urgent and emergency care needs in UK emergency departments. Emerg Med J. 2013 Sep;30(9):699-700. doi: 10.1136/emermed-2012-202080. Epub 2012 Dec 18. No abstract available.
- Background: PubMed 19175914Hamilton HJ, Gallagher PF, O'Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatr. 2009 Jan 28;9:5. doi: 10.1186/1471-2318-9-5.
- Background: PubMed 18809816Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.
- Background: PubMed 25187228Gheewala PA, Peterson GM, Curtain CM, Nishtala PS, Hannan PJ, Castelino RL. Impact of the pharmacist medication review services on drug-related problems and potentially inappropriate prescribing of renally cleared medications in residents of aged care facilities. Drugs Aging. 2014 Nov;31(11):825-35. doi: 10.1007/s40266-014-0208-y.
- Background: PubMed 25288041Patterson SM, Cadogan CA, Kerse N, Cardwell CR, Bradley MC, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2014 Oct 7;(10):CD008165. doi: 10.1002/14651858.CD008165.pub3.
- Background: PubMed 29162290Campins L, Serra-Prat M, Palomera E, Bolibar I, Martinez MA, Gallo P. Reduction of pharmaceutical expenditure by a drug appropriateness intervention in polymedicated elderly subjects in Catalonia (Spain). Gac Sanit. 2019 Mar-Apr;33(2):106-111. doi: 10.1016/j.gaceta.2017.09.002. Epub 2017 Nov 20.
- Background: PubMed 21570331Perez Menendez-Conde C, Bermejo Vicedo T, Delgado Silveira E, Carretero Accame E. Adverse drug reactions which provoke hospital admission. Farm Hosp. 2011 Sep-Oct;35(5):236-43. doi: 10.1016/j.farma.2010.08.003. Epub 2011 May 12. English, Spanish.
- Background: PubMed 28463129Donaldson LJ, Kelley ET, Dhingra-Kumar N, Kieny MP, Sheikh A. Medication Without Harm: WHO's Third Global Patient Safety Challenge. Lancet. 2017 Apr 29;389(10080):1680-1681. doi: 10.1016/S0140-6736(17)31047-4. No abstract available.
- Individual participant dataSharing planned: Yes. Monitor clinical trial will have access to all study data
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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.
Laia López Vinardell principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPlan digital health platform and Satndard care in people with Drug-Related Problems, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Juanes Borrego, Doctor (932 91 90 00 ext. 7459, ajuanes@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment. (time frame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)). The study lists 2 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 NCT04841863, which also lists 30 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 12 Apr 2021.