A Digital Flu Intervention for People With Cardiovascular Conditions (CardioFlu)
23 maj 2022 uppdaterad av: Evidation Health
Increasing Influenza Vaccination in Individuals With Cardiovascular Conditions: Assessing the Effectiveness of a Digital Intervention in a Decentralized Randomized Controlled Trial
A 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular conditions
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
49138
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
San Mateo, California, Förenta staterna, 94401
- Evidation Health
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 18 years or older
- Resides in the U.S.
- Speaks, reads, and understands English
- Has self-reported being diagnosed with any of the following cardiac conditions below in their Achievement profile:
- Atrial Fibrillation or Afib
- Abnormal or irregular heart rhythm, other arrhythmic heart disease
- Cardiac arrest, or heart attack (myocardial infarction)
- Coronary heart disease like a heart blockage, treated with medications, a stent in the heart, or sometimes bypass surgery-
- Heart failure, like congestive heart failure
- Stroke or cerebrovascular accident (CVA)
Exclusion Criteria:
- Participated in Step 1, Part 2 semi-structured interviews used to obtain feedback on the intervention messages
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: cardiovascular disorders digital intervention arm (CVD-I)
Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination
|
Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors.
|
|
Inget ingripande: cardiovascular disorders without digital intervention arm
Individuals with cardiovascular disease who receive no intervention
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
Tidsram: Up to 7 months
|
To determine the effectiveness of a digital intervention designed to increase influenza vaccination rates in individuals with cardiovascular diagnoses (CV diagnoses) by examining differences in self-reported influenza vaccination rates between individuals with cardiovascular disease who receive a targeted digital intervention (CVD-I) aimed at increasing influenza vaccination and those with CV diagnoses who received no intervention (CVD-C) by the end of the study period.
|
Up to 7 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
Tidsram: Up to 7 months
|
Differences in rates of self-reported influenza vaccination status after study start between individuals in the intervention group that completed different numbers of intervention messages (0 to 6 messages) over the course of the study
|
Up to 7 months
|
|
Participant Completion Rate
Tidsram: Up to 7 months
|
Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention
|
Up to 7 months
|
|
Self-Reported Influenza Vaccination Status Prediction
Tidsram: Up to 7 months
|
Development of a logistic regression model to predict self-reported influenza vaccination status using vaccination predictors such as vaccine drivers/barriers, and vaccine knowledge.
|
Up to 7 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Nell Marshall, DrPh, Evidation Health
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
- Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.
- Dale LP, White L, Mitchell M, Faulkner G. Smartphone app uses loyalty point incentives and push notifications to encourage influenza vaccine uptake. Vaccine. 2019 Jul 26;37(32):4594-4600. doi: 10.1016/j.vaccine.2018.04.018. Epub 2018 Apr 23.
- Dos Santos G, Tahrat H, Bekkat-Berkani R. Immunogenicity, safety, and effectiveness of seasonal influenza vaccination in patients with diabetes mellitus: A systematic review. Hum Vaccin Immunother. 2018;14(8):1853-1866. doi: 10.1080/21645515.2018.1446719. Epub 2018 Apr 9.
- Doyle JD, Chung JR, Kim SS, Gaglani M, Raiyani C, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Belongia EA, McLean HQ, Foust A, Sessions W, Berman L, Garten RJ, Barnes JR, Wentworth DE, Fry AM, Patel MM, Flannery B. Interim Estimates of 2018-19 Seasonal Influenza Vaccine Effectiveness - United States, February 2019. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-139. doi: 10.15585/mmwr.mm6806a2.
- Frank L, Basch E, Selby JV; Patient-Centered Outcomes Research Institute. The PCORI perspective on patient-centered outcomes research. JAMA. 2014 Oct 15;312(15):1513-4. doi: 10.1001/jama.2014.11100. No abstract available.
- Healthy People 2020. (2019). Retrieved from https://www.healthypeople.gov/. from Healthy People 2020, United States Department of Health and Human Services, Office of Disease Prevention and Health Promotion, https://www.healthypeople.gov/
- Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Breslin K, Dickinson M, Whittington MD, Roth H, Kempe A. RCT of Centralized Vaccine Reminder/Recall for Adults. Am J Prev Med. 2018 Aug;55(2):231-239. doi: 10.1016/j.amepre.2018.04.022. Epub 2018 Jun 15.
- Jackson ML, Chung JR, Jackson LA, Phillips CH, Benoit J, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman R, Nowalk MP, Fry AM, Flannery B. Influenza Vaccine Effectiveness in the United States during the 2015-2016 Season. N Engl J Med. 2017 Aug 10;377(6):534-543. doi: 10.1056/NEJMoa1700153.
- Lee WN, Stuck D, Konty K, Rivers C, Brown CR, Zbikowski SM, Foschini L. Large-scale influenza vaccination promotion on a mobile app platform: A randomized controlled trial. Vaccine. 2020 Apr 16;38(18):3508-3514. doi: 10.1016/j.vaccine.2019.11.053. Epub 2019 Nov 29.
- Nehme EK, Delphia M, Cha EM, Thomas M, Lakey D. Promoting Influenza Vaccination Among an ACA Health Plan Subscriber Population: A Randomized Trial. Am J Health Promot. 2019 Jul;33(6):916-920. doi: 10.1177/0890117118823157. Epub 2019 Jan 10.
- Rolfes MA, Flannery B, Chung JR, O'Halloran A, Garg S, Belongia EA, Gaglani M, Zimmerman RK, Jackson ML, Monto AS, Alden NB, Anderson E, Bennett NM, Billing L, Eckel S, Kirley PD, Lynfield R, Monroe ML, Spencer M, Spina N, Talbot HK, Thomas A, Torres SM, Yousey-Hindes K, Singleton JA, Patel M, Reed C, Fry AM; US Influenza Vaccine Effectiveness (Flu VE) Network, the Influenza Hospitalization Surveillance Network, and the Assessment Branch, Immunization Services Division, Centers for Disease Control and Prevention. Effects of Influenza Vaccination in the United States During the 2017-2018 Influenza Season. Clin Infect Dis. 2019 Nov 13;69(11):1845-1853. doi: 10.1093/cid/ciz075.
- Samson, S., Lee, J., Tai, C., & Foschini, L. (2020, September). Digital intervention is effective at increasing influenza vaccination in people living with diabetes. Poster presented at the European Association for the Science of Diabetes in Vienna, Austria - Conference to occur digitally 22-25 September, 2020 due to COVID-19.
- Samson SI, Konty K, Lee WN, Quisel T, Foschini L, Kerr D, Liska J, Mills H, Hollingsworth R, Greenberg M, Beal AC. Quantifying the Impact of Influenza Among Persons With Type 2 Diabetes Mellitus: A New Approach to Determine Medical and Physical Activity Impact. J Diabetes Sci Technol. 2021 Jan;15(1):44-52. doi: 10.1177/1932296819883340. Epub 2019 Nov 20.
- Marshall NJ, Lee JL, Schroeder J, Lee WN, See J, Madjid M, Munagala MR, Piette JD, Tan L, Vardeny O, Greenberg M, Liska J, Mercer M, Samson S. Influence of Digital Intervention Messaging on Influenza Vaccination Rates Among Adults With Cardiovascular Disease in the United States: Decentralized Randomized Controlled Trial. J Med Internet Res. 2022 Oct 7;24(10):e38710. doi: 10.2196/38710.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 september 2020
Primärt slutförande (Faktisk)
12 april 2021
Avslutad studie (Faktisk)
12 april 2021
Studieregistreringsdatum
Först inskickad
15 september 2020
Först inskickad som uppfyllde QC-kriterierna
6 oktober 2020
Första postat (Faktisk)
14 oktober 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020/08/14
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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 .