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Testing the Impact of the MOHR Follow-up Support

29. april 2026 opdateret af: University of Colorado, Denver

Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition

This study will evaluate the impact of 3 different strategies to increase engagement of participants in My Own Health Report (MOHR) and health behavior change activities over time. This study will evaluate the level of engagement, outcomes, cost and cost-effectiveness of these strategies.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In previous pilot studies was found that patients in clinics randomized to the MOHR intervention vs. control significantly improved physical activity (p < 0.001) and diet risk behaviors (p < 0.001), as well as other risk factors. However, two gaps were identified. First, clinic partners voiced a need for a more flexible menu of delivery options to feasibly adopt and sustain the intervention. Second, to achieve sustained behavior change, particularly for those with unmet social needs, clinics need to provide structured follow-up. Structured follow-up bundles are part of the ERIC strategy of "enhance uptake and adherence (among patients)" and "technical assistance." In other work, additional reminders and resources improved outcomes of goal-setting interventions in general and among those with unmet social needs, so the study team operationalized these to be delivered either electronically (Reminder and Resources (R2) Message) or by a person (R2 Navigation). To fill these two gaps, we engaged with a subset of both UCHealth and rural primary care clinics and patient advisors to co-develop a menu of delivery options for the MOHR intervention and also a menu of options for the R2 Message and R2 Navigation strategy bundles.

In a randomized comparative effectiveness-implementation trial the study team will enroll 1,000 adult patients with two or more cancer risks (including both insufficient physical activity and fruit/vegetable intake). The study team will evaluate the outcomes of R2 Message and R2 Navigation alone or in combination. Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) improvement in practice value outcomes, including patient experience ratings.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1000

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Rekruttering
        • University of Colorado Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Amy Huebschmann
      • Denver, Colorado, Forenede Stater, 80206
        • Rekruttering
        • UCHealth Cherry Creek Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Amy Huebschmann
      • Denver, Colorado, Forenede Stater, 80045
        • Rekruttering
        • UCHealth Women's Integrated Services in Health (WISH)
        • Kontakt:
      • Denver, Colorado, Forenede Stater, 80230
        • Rekruttering
        • UCHealth Internal Medical Clinic - Lowry
        • Kontakt:
        • Ledende efterforsker:
          • Amy Huebschmann
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rekruttering
        • UCHealth Lone Tree Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Amy Huebschmann
      • Westminster, Colorado, Forenede Stater, 80021
        • Rekruttering
        • UCHealth Family Medicine - Westminster
        • Kontakt:
        • Ledende efterforsker:
          • Amy Huebschmann

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults, aged 18 years and older.
  • Completion of the MOHR health risk assessment and goal-setting tool
  • Score in the "at-risk" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit/vegetables
  • Patient at one of the participating clinics

Exclusion Criteria:

  • Incomplete or no MOHR assessment
  • Language preference/proficiency other than English or Spanish
  • Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).

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
Aktiv komparator: Control Arm
Standardized version of usual care
Adfærdsmæssigt: Regular care
Regular (standard) care provided by healthcare provider team
Eksperimentel: R2 Message Only
Reminder and Resources Messages sent to patient
Adfærdsmæssigt: Regular care
Regular (standard) care provided by healthcare provider team
Adfærdsmæssigt: Providing reminder and resources via messages
Patients will be provided reminders and resources using messages sent to patients.
Eksperimentel: R2 Navigation only
Reminder and Resources provided to patient via health navigator
Adfærdsmæssigt: Regular care
Regular (standard) care provided by healthcare provider team
Adfærdsmæssigt: Reminder and resources sent via navigation
Patients will be provided reminders and resources using health navigators calling the patients.
Eksperimentel: R2 Message + R2 Navigation
Both reminder and resources messages and navigation provided to the patient
Adfærdsmæssigt: Regular care
Regular (standard) care provided by healthcare provider team
Adfærdsmæssigt: Providing reminder and resources via messages
Patients will be provided reminders and resources using messages sent to patients.
Adfærdsmæssigt: Reminder and resources sent via navigation
Patients will be provided reminders and resources using health navigators calling the patients.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of MOHR risk factors
Tidsramme: From enrollment to the follow-up survey timepoint at 2 months.
Primary effectiveness outcome measured on scale from -6 to +6 as change of the number of risk factors improved. MOHR questions are organized into 6 risk areas: 1) intake of fruits and vegetables; 2) high sugar beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep. Each risk factor is evaluated as low risk, medium risk, or high risk. Level of improvement in risk factors outcome will be a count score from -6 to 6 (any improvement or decrement in level of risk in each factor will count as 1 or -1).
From enrollment to the follow-up survey timepoint at 2 months.
REACH - specifically representative engagement
Tidsramme: From enrollment to the follow-up survey timepoint at 6 months.
Primary implementation outcome. Representative engagement: Engagement during the follow-up period involves interactions over time of the participant with either or both a navigator or text messages . Engagement will be assessed percent of navigator calls completed (maximum of 12 over 6 months) and percent of text messages successfully sent (maximum of 60 over 6 months). To assess whether engagement is representative our primary assessments will be if there is differential engagement across conditions (e.g., an interaction effect) based on 1) number of baseline social needs, 2) Latine vs. non Latine ethnicity or 3) digital literacy.
From enrollment to the follow-up survey timepoint at 6 months.
Patient experience
Tidsramme: From enrollment to the follow up survey time point at 6 months.
Primary practice value outcome measured by change in mean score on Patient Assessment of Quality-of-Care subscales of goal setting/tailoring and follow-up/coordination (PACIC). Scale ranges from almost never (indicating the worst patient experience) to almost always (indicating the best patient experience).
From enrollment to the follow up survey time point at 6 months.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Colorado, Denver

Samarbejdspartnere

National Cancer Institute (NCI)

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 (Anslået)

20. april 2026

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 25-0224.cc
  • 1R01CA282292-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Due to HIPAA we cannot share IPD from EHR.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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