- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04841863
Secondary Prevention of Dug-related Problems Through Digital Health
Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ana Juanes Borrego, Doctor
- Telefonnummer: 7459 932 91 90 00
- E-post: ajuanes@santpau.cat
Studera Kontakt Backup
- Namn: Jesús Ruiz Ramos, Doctor
- Telefonnummer: 7459 932 91 90 00
- E-post: jruiz@santpau.cat
Studieorter
-
-
-
Barcelona, Spanien
- Hospital de La Santa Creu i Sant Pau
-
Kontakt:
- Ana Juanes, Doctor
- E-post: ajuanes@santpau.cat
-
Kontakt:
- Jesús Ruiz, Doctor
- E-post: jruiz@santpau.cat
-
Huvudutredare:
- Laia López
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Drug Code Active Patient o DCAP
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. |
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.
|
Placebo-jämförare: Standard care
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. |
Inclusion in the control group do not involves the use of MyPlan digital health tool.
Patients will receive the standard of care.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Tidsram: 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)
|
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.
Tidsram: 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)
|
Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Tidsram: Baseline
|
Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)
|
Baseline
|
Identify risk factors for ED visits related to DRP
Tidsram: Baseline
|
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.
|
Baseline
|
Identify which groups of drugs are more frequently associated to DRP
Tidsram: Baseline
|
Using ATC group classification
|
Baseline
|
Change in the patient therapeutic adherence
Tidsram: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
|
Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Change in the patient therapeutic adherence
Tidsram: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
|
Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Mesure therapeutic complexity
Tidsram: Baseline
|
Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
|
Baseline
|
Identify predictive factors of a greater capacity for digital empowerment.
Tidsram: Baseline
|
Using the CAMBADOS questionnaire
|
Baseline
|
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Tidsram: 90-day after discharge (in phase I, Pilot Trial)
|
Using the TrilemaSalud questionnaire
|
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
Tidsram: 12-month after discharge (in phase II, Clinical Trial)
|
Using the TrilemaSalud questionnaire
|
12-month after discharge (in phase II, Clinical Trial)
|
Change in the quality of life of patients in the active group
Tidsram: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Using the EQ-5D-3L51 questionnaire
|
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
Tidsram: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Using the EQ-5D-3L51 questionnaire
|
Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publikationer och användbara länkar
Allmänna publikationer
- Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.
- Tickle-Degnen L. Nuts and bolts of conducting feasibility studies. Am J Occup Ther. 2013 Mar-Apr;67(2):171-6. doi: 10.5014/ajot.2013.006270.
- Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. J Clin Oncol. 2019 Feb 20;37(6):528.
- 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.
- Hamilton 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.
- de la Torre-Diez I, Lopez-Coronado M, Vaca C, Aguado JS, de Castro C. Cost-utility and cost-effectiveness studies of telemedicine, electronic, and mobile health systems in the literature: a systematic review. Telemed J E Health. 2015 Feb;21(2):81-5. doi: 10.1089/tmj.2014.0053. Epub 2014 Dec 4.
- Park 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.
- Patel 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.
- Baena 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.
- Castro 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.
- Banerjee 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.
- Leendertse 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.
- Gheewala 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.
- Patterson 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. Review. Update in: Cochrane Database Syst Rev. 2018 Sep 03;9:CD008165.
- Campins 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.
- Perez 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.
- Donaldson 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.
- Lancaster 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.
- Martinez-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.
- Ritterband LM, Andersson G, Christensen HM, Carlbring P, Cuijpers P. Directions for the International Society for Research on Internet Interventions (ISRII). J Med Internet Res. 2006 Sep 29;8(3):e23. doi: 10.2196/jmir.8.3.e23.
- Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial. J Med Internet Res. 2015 Jun 10;17(6):e142. doi: 10.2196/jmir.4550.
- Piette JD, List J, Rana GK, Townsend W, Striplin D, Heisler M. Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. Circulation. 2015 Nov 24;132(21):2012-27. doi: 10.1161/CIRCULATIONAHA.114.008723.
- Comin-Colet J, Enjuanes C, Verdu-Rotellar JM, Linas A, Ruiz-Rodriguez P, Gonzalez-Robledo G, Farre N, Moliner-Borja P, Ruiz-Bustillo S, Bruguera J. Impact on clinical events and healthcare costs of adding telemedicine to multidisciplinary disease management programmes for heart failure: Results of a randomized controlled trial. J Telemed Telecare. 2016 Jul;22(5):282-95. doi: 10.1177/1357633X15600583. Epub 2015 Sep 7.
- Wei L, Yang X, Li J, Liu L, Luo H, Zheng Z, Wei Y. Effect of pharmaceutical care on medication adherence and hospital admission in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled study. J Thorac Dis. 2014 Jun;6(6):656-62. doi: 10.3978/j.issn.2072-1439.2014.06.20.
- Koshman SL, Charrois TL, Simpson SH, McAlister FA, Tsuyuki RT. Pharmacist care of patients with heart failure: a systematic review of randomized trials. Arch Intern Med. 2008 Apr 14;168(7):687-94. doi: 10.1001/archinte.168.7.687.
- Ravn-Nielsen LV, Duckert ML, Lund ML, Henriksen JP, Nielsen ML, Eriksen CS, Buck TC, Pottegard A, Hansen MR, Hallas J. Effect of an In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: A Randomized Clinical Trial. JAMA Intern Med. 2018 Mar 1;178(3):375-382. doi: 10.1001/jamainternmed.2017.8274.
- Gomis-Pastor M, Roig Mingell E, Mirabet Perez S, Brossa Loidi V, Lopez Lopez L, Diaz Bassons A, Aretio Pousa A, Feliu Ribera A, Ferrero-Gregori A, Guirado Perich L, Mangues Bafalluy MA. Multimorbidity and medication complexity: New challenges in heart transplantation. Clin Transplant. 2019 Oct;33(10):e13682. doi: 10.1111/ctr.13682. Epub 2019 Aug 28.
- Anglada-Martinez H, Martin-Conde M, Rovira-Illamola M, Sotoca-Momblona JM, Sequeira E, Aragunde V, Moreno MA, Catalan M, Codina-Jane C. Feasibility and Preliminary Outcomes of a Web and Smartphone-Based Medication Self-Management Platform for Chronically Ill Patients. J Med Syst. 2016 Apr;40(4):99. doi: 10.1007/s10916-016-0456-y. Epub 2016 Feb 12.
- Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.
- Chen CE, Harrington RA, Desai SA, Mahaffey KW, Turakhia MP. Characteristics of Digital Health Studies Registered in ClinicalTrials.gov. JAMA Intern Med. 2019 Jun 1;179(6):838-840. doi: 10.1001/jamainternmed.2018.7235.
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IIBSP-COD-2019-46
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- Studieprotokoll
- Statistisk analysplan (SAP)
- Informerat samtycke (ICF)
- Klinisk studierapport (CSR)
- Analytisk kod
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Narkotikarelaterade problem
-
Astellas Pharma Europe B.V.AvslutadFriska ämnen | Farmakokinetik | Drug-Drug Interaction (DDI)Tyskland
-
Astellas Pharma Europe B.V.AvslutadFriska ämnen | Drug-Drug Interaction (DDI)Frankrike
-
Theravance BiopharmaAvslutad
-
Astellas Pharma Europe B.V.Medivation, Inc.AvslutadFriska ämnen | Drug-Drug Interaction (DDI) | Enzalutamids farmakokinetikTyskland
-
Astellas Pharma Europe B.V.AvslutadFriska ämnen | Drug-Drug Interaction (DDI)Storbritannien
-
The Netherlands Cancer InstituteHar inte rekryterat ännuDrug Adherence Marker
-
Astellas Pharma Europe B.V.AvslutadFriska ämnen | Farmakokinetik | Drug-Drug Interaction (DDI)Tyskland
-
Astellas Pharma Europe B.V.Cubist Pharmaceuticals LLCAvslutadFriska ämnen | Drug-Drug Interaction (DDI) | Intestinal absorption | Rosuvastatins farmakokinetik | Farmakokinetiken för FidaxomicinTyskland
-
Astellas Pharma Europe B.V.AvslutadFriska ämnen | Farmakokinetik | DDI (Drug-Drug Interaction)Tyskland
-
University Medical Center GroningenBoehringer Ingelheim; CSL BehringOkänd
Kliniska prövningar på MyPlan digital health platform
-
Johns Hopkins UniversityApple Inc.; iHealthAvslutadHjärtinfarkt | Kranskärlssjukdom | Akut koronarsyndrom | Akut hjärtinfarktFörenta staterna
-
M.A.G.I.C. Clinic LTDHanalytics Solutions Inc.RekryteringMitokondriella sjukdomar | Fabrys sjukdom | Metabolisk sjukdom | Gauchers sjukdom | Pompes sjukdomKanada
-
Pack HealthGlaxoSmithKline; University of WashingtonRekryteringMultipelt myelom | Återfall av hematologisk malignitetFörenta staterna
-
University of Alabama at BirminghamAmerican Heart Association; ConnectionHealth; Memora HealthRekryteringGraviditet | Skillnader | SpädbarnFörenta staterna
-
Deutsches Herzzentrum MuenchenInstitute of Preventive Pediatrics, Technical University of Munich; Stiftung...Avslutad
-
Rhode Island HospitalEmory UniversityRekryteringHIV | Medicinering vidhäftning | TelemedicinFörenta staterna
-
WV Health Right, Inc.ViiV HealthcareRekryteringHIV-infektionerFörenta staterna
-
University of VictoriaAvslutadFysisk aktivitet | HälsofrämjandeKanada
-
Scripps HealthWest Virginia UniversityAvslutadHjärt-kärlsjukdomar | Hjärtsvikt | Hypertoni | Förmaksflimmer | Metaboliskt syndrom | Genetisk sjukdomFörenta staterna
-
NYU Langone HealthNational Institute on Minority Health and Health Disparities (NIMHD)RekryteringMental hälsaFörenta staterna