- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04841863
Secondary Prevention of Dug-related Problems Through Digital Health
Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ana Juanes Borrego, Doctor
- Telefonní číslo: 7459 932 91 90 00
- E-mail: ajuanes@santpau.cat
Studijní záloha kontaktů
- Jméno: Jesús Ruiz Ramos, Doctor
- Telefonní číslo: 7459 932 91 90 00
- E-mail: jruiz@santpau.cat
Studijní místa
-
-
-
Barcelona, Španělsko
- Hospital de la Santa Creu i Sant Pau
-
Kontakt:
- Ana Juanes, Doctor
- E-mail: ajuanes@santpau.cat
-
Kontakt:
- Jesús Ruiz, Doctor
- E-mail: jruiz@santpau.cat
-
Vrchní vyšetřovatel:
- Laia López
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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.
|
Komparátor placeba: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Časové okno: 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.
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
Using ATC group classification
|
Baseline
|
Change in the patient therapeutic adherence
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
|
Baseline
|
Identify predictive factors of a greater capacity for digital empowerment.
Časové okno: Baseline
|
Using the CAMBADOS questionnaire
|
Baseline
|
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IIBSP-COD-2019-46
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
- Formulář informovaného souhlasu (ICF)
- Zpráva o klinické studii (CSR)
- Analytický kód
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Problémy související s drogami
-
Natalia Valadares de MoraesHospital das Clínicas de Ribeirão PretoNeznámý
-
Washington State UniversityNational Center for Complementary and Integrative Health (NCCIH)DokončenoInterakce Drug FoodSpojené státy
-
Washington State UniversityNational Center for Complementary and Integrative Health (NCCIH); Office of...Aktivní, ne náborInterakce Drug FoodSpojené státy
-
Washington State UniversityNational Center for Complementary and Integrative Health (NCCIH)DokončenoInterakce Drug FoodSpojené státy
-
Ventrus Biosciences, IncTKL Research, Inc.DokončenoCLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]Spojené státy
-
King Faisal Specialist Hospital & Research CenterDokončenoFarmakokinetika | Placebo efekt | Drug Half LifeSaudská arábie
-
Beijing Anzhen HospitalNeznámýLOVASTATIN/TICAGRELOR [VA Drug Interaction]Čína
-
University Medicine GreifswaldDokončenoMRI | Farmakokinetika | Játra | Drug Transporter | Gd-EOB-DTPANěmecko
-
Shandong Cancer Hospital and InstituteNeznámýOnemocnění jater | Novotvary podle histologického typu | Novotvary podle místa | Adenokarcinom | Karcinom | Novotvary, žlázové a epiteliální | Novotvary trávicího systému | Karcinom, Hepatocelulární | Novotvary jater | HBV | FENYTOIN/SORAFENIB [VA Drug Interaction] | DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]Čína
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do SulNeznámýStárnutí | Interakce Drug Food | Primární hypotyreózaBrazílie
Klinické studie na MyPlan digital health platform
-
Columbia UniversityNational Institute of Nursing Research (NINR)DokončenoAntikoncepční chováníSpojené státy
-
WV Health Right, Inc.ViiV HealthcareNábor
-
Rhode Island HospitalEmory UniversityNáborHIV | Adherence léků | TelemedicínaSpojené státy
-
Pack HealthGlaxoSmithKline; University of WashingtonNáborMnohočetný myelom | Recidivující hematologická malignitaSpojené státy
-
University of California, San DiegoNational Institute of Mental Health (NIMH); Gilead Sciences; ViiV HealthcareAktivní, ne náborHIV/AIDSSpojené státy
-
Memorial Sloan Kettering Cancer CenterUniversity of Pennsylvania; University of California, Los Angeles; Dana-Farber... a další spolupracovníciAktivní, ne nábor
-
Massachusetts Institute of TechnologyMcGill University; United States Agency for International Development (USAID); Kehea... a další spolupracovníciDokončenoTuberkulóza | Adherence, léky | Tuberkulóza odolná vůči lékům | Přilnavost, pacienteKeňa
-
CoheroHealthLindus Health; Aptar Digital HealthZatím nenabíráme
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)NáborPre-expoziční profylaxe HIVSpojené státy
-
Milton S. Hershey Medical CenterPenn State University; Congressionally Directed Medical Research ProgramsNábor