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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02456090
Other study ID # STUDY20110295
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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