Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)
28. Januar 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
80
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60611
- Northwestern Medicine
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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
|
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.
|
|
Experimental: 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.
Verhalten: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
Zeitfenster: Baseline - 6 Months
|
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))
|
Baseline - 6 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Costs to Implement the Intervention
Zeitfenster: Baseline - 12 Months
|
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
|
Baseline - 12 Months
|
|
Change in Hemoglobin A1C
Zeitfenster: Baseline - 12 Months
|
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Systolic Blood Pressure
Zeitfenster: Baseline - 12 Months
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Mean change in systolic blood pressure (mmHg) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Total Cholesterol
Zeitfenster: Baseline - 12 Months
|
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Non-HDL Cholesterol
Zeitfenster: Baseline - 12 Months
|
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
|
Baseline - 12 Months
|
|
Body Mass Change at 6 Months
Zeitfenster: Baseline - 6 Months
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Mean Change in Body Mass (kg) from Baseline to 6 Months
|
Baseline - 6 Months
|
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Body Mass Change at 12 Months
Zeitfenster: Baseline - 12 Months
|
Mean Change in Body Mass (kg) from Baseline to 12 Months
|
Baseline - 12 Months
|
|
Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
Zeitfenster: Baseline - 12 Months
|
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))
|
Baseline - 12 Months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
16. Dezember 2019
Primärer Abschluss (Tatsächlich)
30. Juni 2020
Studienabschluss (Tatsächlich)
30. Juni 2021
Studienanmeldedaten
Zuerst eingereicht
21. Juni 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Juni 2019
Zuerst gepostet (Tatsächlich)
25. Juni 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Februar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Januar 2022
Zuletzt verifiziert
1. Januar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU00207153
- R34DK114773 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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