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Individualizing Disease Prevention for Middle-Aged Adults

30. marts 2022 opdateret af: Glen Taksler
The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Scheduled for an appointment with primary care provider during study period
  • Two or more of the following risk factors:
  • Tobacco use
  • Overweight/obese
  • Hypertension
  • Hyperlipidemia
  • Diabetes
  • Alcohol Misuse
  • Depression
  • History of Sexually Transmitted Infection
  • Being overdue for the following screenings: Colorectal, cervical, breast, lung

Exclusion Criteria:

- Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Sædvanlig pleje
Eksperimentel: Intervention
Individualized preventive care recommendations will be distributed to subjects.
Andet: Intervention
Written material provided.
Eksperimentel: Development Phase
Non-randomized receipt of individualized preventive care recommendations
Andet: Intervention
Written material provided.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Interest in Individualized Preventive Care Recommendations.
Tidsramme: Within 3 days of index primary care appointment.

Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.

Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)
Within 3 days of index primary care appointment.
Interest in Individualized Preventive Care Recommendations.
Tidsramme: Within 3 days of index primary care appointment.

Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.

Survey question: "In the future, would you like to see updated written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)
Within 3 days of index primary care appointment.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Use of Shared Decision Making.
Tidsramme: Within 3 days of index primary care appointment.
Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)
Within 3 days of index primary care appointment.
Patient Readiness to Change Health Behaviors.
Tidsramme: Within 3 days of index primary care appointment.
Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
Within 3 days of index primary care appointment.
Patient Readiness to Change Health Behaviors
Tidsramme: Within 3 days of index primary care appointment
Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
Within 3 days of index primary care appointment
Patient Readiness to Change Health Behaviors.
Tidsramme: Within 3 days of index primary care appointment
Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
Within 3 days of index primary care appointment
Patient Readiness to Change Health Behaviors
Tidsramme: Within 3 days of index primary care appointment
Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
Within 3 days of index primary care appointment
Decisional Comfort.
Tidsramme: Within 3 days of index primary care appointment.
Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)
Within 3 days of index primary care appointment.
Preventive Care Outcomes for Patients.
Tidsramme: Within 1 year of index primary care appointment.
Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.
Within 1 year of index primary care appointment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Glen Taksler

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Glen Taksler, PhD, The Cleveland Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. februar 2017

Primær færdiggørelse (Faktiske)

12. marts 2020

Studieafslutning (Faktiske)

12. marts 2021

Datoer for studieregistrering

Først indsendt

13. januar 2017

Først indsendt, der opfyldte QC-kriterier

13. januar 2017

Først opslået (Skøn)

18. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 16-854

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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