PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles and Health Care

Weight Clinical Trial

Official title:

PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles and Health Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02456090
• Other study ID #: STUDY20110295
• Status: Active, not recruiting
• Start date: May 2015
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.

Description:

The primary objective is to create the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care, which will allow the conduct of patient-centered observational studies on weight across the multiple institutions of the PaTH network. Creating the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care will involve:

1. Recruiting patients with longitudinal weight data in the EHR to participate in the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care

2. Administering surveys to the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care approximately every 6 months to collect patient reported outcomes (PROs)

3. Collecting individual patient health record data into the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care database

4. Identifying potential participants for future research studies.

5. Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.

The secondary objectives are to use the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care to answer patient-centered research questions including:

(1) How do survey response rates, sample demographics and survey responses differ by recruitment technique? (2) What are patients' weight management strategies? How much are health care providers contributing to their weight management approaches? Do these relationships vary by weight status, region, age, sex, or race; (3) What are patients' reasons for seeking bariatric surgery and expectations in terms of weight change?; (4) Among patients seeking bariatric surgery, what proportion with high risk for sleep apnea by survey responses have been evaluated for or diagnosed with this health problem? (5) How does physical activity vary with patients co-morbidity status?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age in years (>= 18 years), at the time of the initial data query

• Height - at least 1 at any time; can be outside 5-year cohort time window

• Weight : Two encounters each with weight within the 5-year cohort time window

Exclusion Criteria:

• Deceased

• Not proficient in English

• Already enrolled in the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care in another PaTH institution

Related Conditions & MeSH terms

• Weight

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Geisinger	Danville	Pennsylvania
United States	Jody McCullough	Hershey	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pittsburgh	Geisinger Clinic, Johns Hopkins University, Penn State University, Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care	Create the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care, which will allow the conduct of patient-centered observational studies on weight across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.	18 months