- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07559409
CORE Study - Research Into Weight Management Services in the UK (CORE)
Clinical Observations and Research on Engagement in Weight Management Services
Weight management services (previously known as Tier 3 services) represent a multidisciplinary specialist approach, available in community or secondary care settings. This tier caters to individuals with a Body Mass Index (BMI) greater than 35 (or over 30 if they have diabetes) and complex medical conditions, offering pharmacotherapy, low-energy liquid diets, and pre- and post-bariatric surgery care. Tier 4 services, located within secondary care, focus on bariatric surgery.
Data on obesity rates are systematically collected by the National Audit Office, enabling monitoring of Tier 1 effectiveness. Additionally, the National Bariatric Database provides insights into bariatric surgery rates, patient characteristics, and surgical outcomes.
However, comprehensive data on weight management services remain scarce, with information primarily available from only 4 of the 42 weight management clinics. Consequently, it is challenging to ascertain the availability of weight management services across different regions, the volume of referrals, the demographics of individuals accessing these services, and their outcomes during treatment. This lack of data hinders our ability to evaluate equitable access, appropriate referrals, and the overall effectiveness of these services throughout the UK.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Bristol, Det Forenede Kongerige
- Society for Endocrinology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients able to provide informed consent
- Patients able to download and use an English Language app
- Patients seen in a weight management service
Exclusion Criteria:
- Patients unable to comply with the inclusion criteria
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To demonstrate that our system can be integrated into NHS specialist weight management clinics and collect data on patients attending clinics.
Tidsramme: 24 months
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The number of clinics using the system by end of year 2 of the project. Our aim would be to have 50% of weight management clinics using this system. That the clinics on average are collecting data on 60% of the patients that attend their clinics and on these they have at least 80% data on our key outcomes |
24 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- SfECORE
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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