Development and Validation of a Scale of Propensity for Change in Chronic Disease Prevention (ProChange)
10. august 2026 oppdatert av: University Hospital, Toulouse
Development and Validation of a Propensity-to-change Scale in the Field of Chronic Disease Prevention: the ProChange Scale
Modifiable risk factors are estimated to account for 70% of cardiovascular diseases, 40% of Alzheimer's-type dementias, and 50% of type 2 diabetes cases. Numerous trials have evaluated interventions aimed at modifying these risk factors, whether through the promotion of healthy lifestyle choices (diet, physical activity, etc.) or specific activities (cognitive training, etc.). However, these trials have yielded inconsistent or modest results, potentially due to a failure to adopt the recommended lifestyle changes. To better tailor prevention interventions, it is therefore essential to have scales available that measure the barriers to and facilitators of lifestyle change.
The aim of this study is to develop and validate a Patient-Reported Outcome Measure (PROM) to assess the barriers to and facilitators of change following participation in a prevention program. The scale will be structured into three sub-scales (capability, opportunity, and motivation), administered one month after the prevention activity, and will distinguish between the adoption of new habits and the abandonment of existing ones.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
290
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jason SHOURICK, MD
- Telefonnummer: +33 05 61 14 56 23
- E-post: shourick.j@chu-toulouse.fr
Studiesteder
-
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Oui
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Toulouse, Oui, Frankrike, 31000
- Service d'Epidémiologie Clinique et de Santé Publique CHU de Toulouse, Pôle Santé Publique et Médecine Sociale Faculté de Médecine, 37 allées Jules Guesde
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Ta kontakt med:
- Emeline Muller
- Telefonnummer: 0561778707
- E-post: muller.E@chu-toulouse.Fr
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Ta kontakt med:
- MULLER
- E-post: muller.E@chu-toulouse.Fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients benefiting from a personalized prevention program in the context of geriatrics or cardiovascular diseases.
Beskrivelse
Inclusion Criteria:
- Participant receiving a personalized prevention intervention through the frailty assessment day-hospital program, the Atherosclerosis Detection and Prevention Center (CDPA), or the Salutance program,
- Participant who has received prevention advice aimed at improving their health in at least one of the following two areas: nutrition or physical activity,
- Participant aged 45 or older (we are targeting a middle-aged to older population, as this group is the primary target for cardiovascular prevention initiatives and efforts to prevent pathological aging),
Exclusion Criteria:
- Participant unable to improve their lifestyle, according to the scales used in the study (participant with a maximum score on the ONAPS-PAQ scale and the food frequency score),
- Participant without a postal or email address,
- Participant with a life expectancy of less than 5 years.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Patients benefiting from a personalized prevention initiative
patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health
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Questionnaire administered to patients to develop the scale's items and group them into subscales.
The scale will be administered to the patient in the form of a questionnaire for the testing phase.
The scale will be administered to patients in the form of questionnaires for the validation phase.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Development of the Prochange scale assessing barriers to and facilitators of lifestyle changes for the adoption of non-pharmacological strategies in the field of prevention.
Tidsramme: 3 months after the inclusion
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Development of a scale based on COSMIN criteria (COnsensus-based Standards for the selection of health Measurement INstruments), consisting of three subscales of 10 questions each.
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3 months after the inclusion
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Measurement of the area under the curve of the Prochange scale for the prediction of an improvement in lifestyle at 3 months after the initiation of a preventive action
Tidsramme: 3 months after the inclusion
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3 months after the inclusion
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Comparison of the performance of the ProChange scale with that of pre-existing scales in predicting lifestyle change three months after the initiation of a prevention intervention.
Tidsramme: 3 months after the inclusion
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3 months after the inclusion
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Evaluation of the correlation between the score obtained on the ProChange scale one month after the prevention intervention and the extent of lifestyle modification three months after the initiation of the prevention intervention
Tidsramme: 3 months after the inclusion
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3 months after the inclusion
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Comparison of the ProChange scale with pre-existing scales
Tidsramme: 3 months after the inclusion
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Comparison of the ProChange scale with pre-existing scales in terms of the correlation between the score obtained on the scale one month after the prevention intervention and the extent of lifestyle change three months after the initiation of the prevention intervention.
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3 months after the inclusion
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2028
Studiet fullført (Antatt)
1. juni 2028
Datoer for studieregistrering
Først innsendt
22. juli 2026
Først innsendt som oppfylte QC-kriteriene
10. august 2026
Først lagt ut (Faktiske)
14. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC31/24/0573
- ID-RCB (Annen identifikator: 2025-A00414-45)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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