Coordinating Pragmatic Primary Care Population Management... | NCT03998046

NCT03998046

ID	Type	Description	Link
R34DK114773	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Basic Resources and Services	Active Comparator	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	Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
Coordinated Primary Care Population Management (C3PO)	Experimental	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.	Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Outreach Support for Weight Loss Goal Setting and Self-Weighing	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Achieved 5% Weight Loss Goal at 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

Secondary Outcomes

Measure	Description	Time Frame
Costs to Implement the Intervention	Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components	Baseline - 12 Months
Change in Hemoglobin A1C

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Medicine		Chicago	Illinois	60611	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Basic Resources and Services	Patients received 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
FG001	Coordinated Primary Care Population Management (C3PO)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 1, 2020	Nov 15, 2021

Masking Info

Arm/Group Information

ID	Title	Description
BG000	Basic Resources and Services	Patients received 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.
BG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00038 BG00142 BG00280

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0016

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		.85														Superiority

Secondary

Costs to Implement the Intervention

Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components

Intervention cost inputs include personnel, supplies, contract services, and facility and administrative costs, all from the perspective of the health system. Research-only costs were excluded from intervention cost estimations.

Posted

Number

US Dollars per enrolled participant

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Secondary

Change in Hemoglobin A1C

Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months

Posted

Mean

Standard Deviation

Percent of HbA1C

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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.
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts
Participants	OG000

Secondary

Change in Systolic Blood Pressure

Mean change in systolic blood pressure (mmHg) from baseline to 12 months

Posted

Mean

Standard Deviation

mmHg

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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.
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts
Participants	OG000

Secondary

Change in Total Cholesterol

Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months

Posted

Mean

Standard Deviation

mg/dL

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts
Participants	OG000

Secondary

Change in Non-HDL Cholesterol

Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months

Posted

Mean

Standard Deviation

mg/dL

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts
Participants	OG000

Secondary

Body Mass Change at 6 Months

Mean Change in Body Mass (kg) from Baseline to 6 Months

Posted

Mean

Standard Deviation

Baseline - 6 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts
Participants	OG000

Secondary

Body Mass Change at 12 Months

Mean Change in Body Mass (kg) from Baseline to 12 Months

Posted

Mean

Standard Deviation

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Achieved 5% Weight Loss Goal in 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))

Posted

Count of Participants

Participants

Baseline - 12 Months

ID	Title	Description
OG000	Basic Resources and Services	Patients received 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
OG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Basic Resources and Services	Patients received 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.	0	38	0	38	0	38
EG001	Coordinated Primary Care Population Management (C3PO)	Patients received 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. .	0	42	0	42	0	42

The COVID-19 pandemic began 6-10 weeks into the 12-week active intervention phase. The Illinois stay-at-home order interfered with access to intervention resources as fitness facilities were closed for several months. It also interfered with completion of healthcare visits where follow-up weight measures are captured. Outcome effects observed in this context may not be generalizable if replicated after the Coronavirus pandemic.

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D052439	Lipid Metabolism Disorders

ID	Term
D009765	Obesity
D050177	Overweight
D011236	Prediabetic State
D003924	Diabetes Mellitus, Type 2
D006973	Hypertension
D050171	Dyslipidemias