Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)
28 januari 2022 uppdaterad av: Ronald Ackermann, Northwestern University
The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector.
With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness.
A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern Medicine
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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:
- BMI ≥ 27 kg/m2
- ≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
- Registered in Northwestern Medical Group's EpicCare MyChart patient portal
- Received and completed MyChart survey of weight loss interest
- Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.
Exclusion Criteria:
- Evidence of hospitalization in past 30 days
- Most recent blood pressure >180/105
- Cancer (non-skin) treatment within the past 2 years
- Encounter diagnosis for hypoglycemia in past 30 days
- Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Basic Resources and Services
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
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Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
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Experimentell: Coordinated Primary Care Population Management (C3PO)
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal.
Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team.
Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
Tidsram: Baseline - 6 Months
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Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
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Baseline - 6 Months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Costs to Implement the Intervention
Tidsram: Baseline - 12 Months
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Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
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Baseline - 12 Months
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Change in Hemoglobin A1C
Tidsram: Baseline - 12 Months
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Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
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Baseline - 12 Months
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Change in Systolic Blood Pressure
Tidsram: Baseline - 12 Months
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Mean change in systolic blood pressure (mmHg) from baseline to 12 months
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Baseline - 12 Months
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Change in Total Cholesterol
Tidsram: Baseline - 12 Months
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Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
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Baseline - 12 Months
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Change in Non-HDL Cholesterol
Tidsram: Baseline - 12 Months
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Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
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Baseline - 12 Months
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Body Mass Change at 6 Months
Tidsram: Baseline - 6 Months
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Mean Change in Body Mass (kg) from Baseline to 6 Months
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Baseline - 6 Months
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Body Mass Change at 12 Months
Tidsram: Baseline - 12 Months
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Mean Change in Body Mass (kg) from Baseline to 12 Months
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Baseline - 12 Months
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Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
Tidsram: Baseline - 12 Months
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Proportion of Participants who Reach a 5% Weight Loss Goal at 12 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 12 months (kg))/(Baseline body mass (kg))
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Baseline - 12 Months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
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)
16 december 2019
Primärt slutförande (Faktisk)
30 juni 2020
Avslutad studie (Faktisk)
30 juni 2021
Studieregistreringsdatum
Först inskickad
21 juni 2019
Först inskickad som uppfyllde QC-kriterierna
24 juni 2019
Första postat (Faktisk)
25 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 januari 2022
Senast verifierad
1 januari 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STU00207153
- R34DK114773 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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Kliniska prövningar på Fetma
-
SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark